On May 12, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference (Press release, Biodesix, MAY 12, 2022, View Source [SID1234614416]). The meeting will take place May 13-18, 2022, in San Francisco, California.

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Data from the abstract titled, The Impact of Plasma Proteomics Biomarker on Clinical Management Decision in Lung Nodules, presented by Dr. J. P. Uribe of Deaconess Medical Center, Boston, Massachusetts, United States, will highlight data that show the impact of the Nodify XL2 integrated proteomic classifier on management decisions in a "real world" clinical setting. Conclusions show that when used in patients with lung nodules with a nodule probability of malignancy (pCA) of ≤ 50%, the blood-based lung nodule risk assessment test was able to support a decrease in chest imaging, outpatient clinic visits and additional invasive procedures without misclassifying benign lung nodules.

An additional presentation titled, ALTITUDE trial design: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules, will review the ALTITUDE study, a first-in-class biomarker study which aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer. The abstract, authored by Michael N. Kammer, Ph.D. of Vanderbilt University Medical Center, Nashville, Tennessee, Steve Springmeyer, MD, Biodesix, Boulder, Colorado and Gerard Silvestri, MD of Medical University of South Carolina, Charleston, South Carolina will be presented at ATS by Dr. Michael Kammer.

Both poster presentations will occur during ATS discussion Session B30 – THE QUEST FOR THE HOLY GRAIL: MODELING AND BIOMARKERS FOR NODULES AND LUNG CANCER. The session, moderated by Edwin Ostrin, MD, PhD. from MD Anderson Cancer Center, Houston, Texas and Adam Fox, MD, from Medical University of South Carolina, Charleston, South Carolina, will occur at the ATS meeting on May 16th, 2022, from 9:30-11:00AM PT, Room 203-204 (South Building, Level 2), Moscone Center.

On May 12, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company and its partners will present seven abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3 – June 7, 2022, and eight abstracts at the 27th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) from June 9 –12, 2022. Research findings to be presented include data on Rylaze/JZP458, Zepzelca (lurbinectedin), Defitelio (defibrotide sodium) and Vyxeos/Vyxeos Liposomal (daunorubicin and cytarabine), also known as JZP351 (Press release, Jazz Pharmaceuticals, MAY 12, 2022, View Source [SID1234614434]).

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"As part of Jazz’s commitment to explore potential new applications of our oncology medicines to address critical needs, we continue to advance programs that could impact difficult-to-treat therapeutic areas," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Our growing, early-stage pipeline, combined with ongoing Jazz-sponsored and partner research across our portfolio, is making significant progress when it comes to addressing unmet patient needs in cancers that have historically lacked scientific advancements."

Highlights from Jazz and its investigational sponsors at the congresses feature data for our medicines across a range of solid tumors and hematological malignancies, including:

An oral presentation at ASCO (Free ASCO Whitepaper) featuring results from Cohort 1 of a Phase 2/3 trial conducted with the Children’s Oncology Group, evaluating the efficacy and safety of Rylaze administered intramuscularly (IM) on a Monday/Wednesday/Friday dosing schedule, for patients living with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL).
Two poster presentations for JZP351 including preliminary results from Arm B (JZP351 in combination with midostaurin) from the Phase 1b V-FAST trial in adults with previously untreated FLT3-mutated acute myeloid leukemia (AML) and data from the Phase 1b trial evaluating lower-intensity JZP351 + venetoclax in adults with newly diagnosed AML who are unfit for intensive chemotherapy. These data will be presented at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).
Four poster presentations at ASCO (Free ASCO Whitepaper) evaluating Zepzelca in a range of small cell lung cancer (SCLC) settings, both as a monotherapy and in combination with other therapies, and in BRCA1/2-associated metastatic breast cancer.
The Jazz-supported presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting are:

Rylaze Presentations

Presentation Title

Author

Presentation Details

Efficacy and safety of intramuscular (IM) recombinant Erwinia asparaginase in acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL): The Children’s Oncology Group (COG) AALL1931 study

Maese L, et al.

Type: Oral presentation

Session: Oral Abstract Session/ Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date: June 7 at 10:45 a.m. EDT

Abstract number: 7001

Abstract Link

Zepzelca Presentations

Presentation Title

Author

Presentation Details

Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial

Navarro A, et al.

Type: Poster

Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Date: June 6 at 9:00 a.m. EDT

Abstract number: 8524

Abstract link

Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study

Cheng Y, et al.

Type: Poster

Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Date: June 6 at 9:00 a.m. EDT

Abstract number: 8580

Abstract link

A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study

Calles Blanco A, et al.

Type: Poster

Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Date: June 6 at 9:00 a.m. EDT

Abstract number: 8581

Abstract link

Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study

Boni V, et al.

Type: Poster

Session: Breast Cancer – Metastatic

Date: June 6 at 9:00 a.m. EDT

Abstract number: 1092

Abstract link

Vyxeos Presentations

Presentation Title

Author

Presentation Details

V-FAST master trial: Preliminary results of treatment with CPX-351 plus midostaurin in adults with newly diagnosed FLT3-mutated acute myeloid leukemia

McCloskey J, et al.

Type: Poster

Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date: June 4 at 9:00 a.m. EDT

Abstract number: 7043

Abstract link

Lower-intensity CPX-351 + venetoclax for patients with newly diagnosed AML who are unfit for intensive chemotherapy

Uy G.L. et al.

Type: Poster

Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date: June 4 at 9:00 a.m. EDT

Abstract number: 7031

Abstract link

The Jazz-supported presentations at the EHA (Free EHA Whitepaper) 27th Congress are:

Vyxeos Liposomal Presentations

Presentation Title

Author

Presentation Details

Lower-intensity CPX-351 + venetoclax for patients with newly diagnosed acute myeloid leukemia who are unfit for intensive chemotherapy

Uy L. G. et al.

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P515

Abstract link

CPX-351 treatment for acute myeloid leukemia in England: Real-world outcomes in adults aged <60 years versus >60 years

Legg A. et al.

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P513

Abstract link

V-FAST master trial: Preliminary results of treatment with CPX-351 plus midostaurin in adults with newly diagnosed FLT3-mutated acute myeloid leukemia

McCloskey J, et al

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P514

Abstract link

Real life experience using front-line CPX-351 for therapy-related and AML-MRC: results from the Spanish PETHEMA registry (IST)

Bernal T, et al

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P508

Abstract link

A randomised comparison of CPX-351 and FLAG-Ida in high risk acute myeloid leukaemia. Results from the NCRI AML19 trial

Russel N, et al

Type: Oral presentation

Date: June 11

Abstract number: S128

Abstract link

Defitelio Presentations

Presentation Title

Author

Presentation Details

Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) after autologogous hematopoietic cell transplantion (HCT): Outcomes of defibrotide-treated adult patients from the DefiFrance study

Mohty M, et al

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P1355

Abstract link

A systematic literature review (SLR) of the manifestations of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) after hematopoietic cell transplant (HCT) in adults versus children

Angus J, et al.

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P1354

Abstract link

Asparaginase Presentations

Presentation Title

Author

Presentation Details

Phase 1 trial of pegcrisantaspase in combination with venetoclax in adults with relapsed or refractory acute myeloid leukemia (R/R AML) – Safety, efficacy and PK/PD in the first two cohorts

Liu Y, et al

Type: Poster

Date: June 10 at 16:30 CEST

Abstract number: P527

Abstract link

All ASCO (Free ASCO Whitepaper) virtual poster presentations and poster discussion presentations will be available on-demand to registered participants for 180 days beginning June 3, 2022. EHA (Free EHA Whitepaper) presentations will be available on-demand beginning June 20, 2022.

About Zepzelca (lurbinectedin)
Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.2

Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

Important Safety Information for ZEPZELCA

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.

Are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

What should I avoid while using ZEPZELCA?

Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:

fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:

loss of appetite 
nausea or vomiting 
pain on the right side of your stomach area (abdomen)
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.

The most common side effects of ZEPZELCA include:

tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here.

ZEPZELCA is a trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license.

About RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn)
RYLAZE, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. RYLAZE has orphan drug designation for the treatment of ALL/LBL in the United States. RYLAZE is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. RYLAZE was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for RYLAZE is available here.

Important Safety Information for Rylaze

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

About Vyxeos/Vyxeos Liposomal (daunorubicin and cytarabine), also known as JZP351
Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor.

In the U.S., Vyxeos is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.1

More information about Vyxeos in the United States, including Full Prescribing Information, BOXED Warning and Medication Guide, is available here.

In Europe, Vyxeos Liposomal (daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Backed by a robust clinical development program including Phase 3 data, Vyxeos is currently approved in more than 30 countries, and Jazz continues to work with regulatory authorities worldwide to bring this innovative therapy to appropriate patients.

The full Summary of Product Characteristics of Vyxeos Liposomal in Europe is available here.

Important Safety Information for VYXEOS/VYXEOS LIPOSOMAL
WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products.

VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients.

VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles, or legs
unusual tiredness
VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
VYXEOS contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

About Defitelio (defibrotide sodium)
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the prevention of VOD.

Please see full Prescribing Information for Defitelio in the United States.

In Europe, defibrotide is marketed under the name Defitelio ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC.
(View Source)

The full Summary of Product Characteristics of Defitelio in Europe is available here.

Important Safety Information for Defitelio
Defitelio should not be given to patients who are:

Currently taking anticoagulants or fibrinolytics
Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

On May 12, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the first quarter of 2022 (Press release, Molecular Templates, MAY 12, 2022, View Source [SID1234614480]).

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"We continue to make meaningful progress in advancing our pipeline of ETBs," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "We recently commenced dosing in Cohort 3 of our Phase 1 study of MT-6402 in PD-L1+ patients. We intend to report additional data from this study in the second half of the year. Dose finding in the MT-5111 and MT-0169 programs is ongoing with clinical data expected this year. We look forward to continued momentum across our pipeline in 2022, including filing an IND for MT-8421, our ETB targeting CTLA-4, and advancing our earlier stage pipeline of ETBs targeting TIGIT, TROP-2, and BCMA."

Company Highlights and Upcoming Milestones

Corporate

MTEM expects to provide periodic updates on MT-6402, MT-5111, and MT-0169 throughout 2022.
MTEM hosted a webinar on MT-6402 (PD-L1 ETB with Antigen Seeding Technology) with David Spigel, M.D. of the Sarah Cannon Research Institute on April 13. A replay of the event (including slides) can be accessed here.
Abstracts on MT-6402 and MT-5111 (HER2 ETB) have been accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to take place June 3-7, 2022, in Chicago, IL.
Gabriela Gruia, M.D. appointed to Board of Directors.
Megan Filoon promoted to General Counsel.
Immuno-oncology ETBs:

MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

Patient enrollment continues in the Phase 1 study of MT-6402 which began in July 2021. MT-6402 is a 3rd generation ETB designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of approved checkpoint inhibitors.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment (TME) are eligible for enrollment.
As of March 2022, twelve patients with relapsed/refractory tumors that express PD-L1 have been treated to date across two dose cohorts: 16 mcg/kg (n=6) and 24 mcg/kg (n=6). Dosing continues with three patients currently enrolled in the 32 mcg/kg cohort (cohort 3).
One patient in cohort 1 (16 mcg/kg) with non-small cell lung cancer (NSCLC) that had progressed after prior checkpoint therapy (PD-1 and CTLA-4) had evaluable-only multiple sites of bone disease that appeared to have resolved on bone scan with only one remaining site which showed decreased uptake. This patient remained on MT-6402 up to cycle 8 when increased uptake was noted on bone scan and treatment was discontinued.
The 16 mcg/kg cohort was completed with no dose-limiting toxicities (DLTs) observed. One DLT was observed in a single patient in cohort 2 (24 mcg/kg). The patient experienced dermatitis that resolved rapidly with systemic steroids. The patient was rechallenged without incident at 24 mcg/kg. No other DLTs have been reported.
Following determination of the maximum tolerated dose (MTD), MTEM plans expansion cohorts to evaluate MT-6402 as a monotherapy in tumor-specific and PD-L1 positive basket tumor cohorts.
MTEM continues to observe pharmacodynamic (PD) effects including monocyte depletion and T cell activation in the 24 mcg/kg cohort. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg generally showing a more rapid and profound PD effect, including monocyte depletion and T cell activation, potentially in a dose-dependent manner.
These PD effects associated with immune activation were seen across the majority of patients irrespective of HLA type or level of tumor PD-L1 staining. The patient that demonstrated tumor regression was one of two patients treated with high tumor PD-L1 expression and may represent engagement of direct tumor cell-kill and antigen seeding.
MT-8421 (CTLA-4 ETB)

Preclinical data from MTEM’s CTLA-4 program were featured in a poster at the AACR (Free AACR Whitepaper) annual meeting held April 8-13, 2022. In a transgenic mouse model expressing human CTLA-4 and bearing syngeneic subcutaneous tumors, MT-8421 treatment depleted immune suppressive regulatory T cells (Tregs) in the TME.
MT-8421 was well tolerated in a non-human primate toxicology study and achieved serum levels well-above projected IC50 concentrations for Tregs in the TME.
IND filing for MT-8421 is expected in 2H22, with clinical studies expected to commence in 2023.
MT-6402 and MT-8421 represent MTEM’s unique approach to immuno-oncology based on dismantling the TME through direct cell-kill of tumor and immune cells and not just the blocking of ligand-ligand interactions seen with current antibody therapeutics.
Research

MTEM continues to expand its unique approach to immuno-oncology targets with lead optimization on a TIGIT-targeting ETB on-going and additional exploration around new immuno-oncology targets.
Targeted Solid Tumor ETBs:

MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated in November 2021 at a dose of 10 mcg/kg.
As of January 2022, 30 patients had been treated with MT-5111 across eight dose escalation cohorts ranging from 0.5 mcg/kg to 13 mcg/kg without any DLTs. Enrollment in the 17 mcg/kg cohort has been initiated.
Dose escalation will continue to determine the MTD, while the breast cancer expansion cohort collects efficacy and safety data.
No signs of capillary leak syndrome (CLS) or significant cardiotoxicity have been observed to date with MT-5111.
Research

Lead optimization on a 3rd generation ETB targeting TROP-2 continues.
Hematologic Malignancy Targeted ETBs:

MT-0169 (CD38 ETB)

The revised protocol for the ongoing Phase 1 study in patients with relapsed/refractory multiple myeloma or non-Hodgkin’s lymphoma is now open. The revised protocol will explore a lower dose of MT-0169 to reduce the risk of adverse events observed at the initial dose and to enable patients to continue MT-0169 therapy for a longer duration that may drive tumor benefit. Importantly, the robust and rapid NK cell depletion that was observed at the starting dose is expected to be observed at lower doses.
MTEM is opening new sites for the Phase 1 study and anticipates enrollment beginning in the second quarter of 2022.
Research

Lead optimization on BCMA, SLAMF-7, and CD45 continues.
Financial Results

The net loss attributable to common shareholders for the first quarter of 2022 was $21.6 million, or $0.38 per basic and diluted share. This compares with a net loss attributable to common shareholders of $26.8 million, or $0.51 per basic and diluted share, for the same period in 2021.

Revenues for the first quarter of 2022 were $8.5 million, compared to $3.2 million for the same period in 2021. Revenues for the first quarter of 2022 were comprised of revenues from collaborative research and development agreements with Takeda and Bristol Myers Squibb.

Total research and development expenses for the first quarter of 2022 were $21.5 million, compared with $21.4 million for the same period in 2021. Total general and administrative expenses for the first quarter of 2022 were $7.6 million, compared with $8.2 million for the same period in 2021.

As of March 31, 2022, MTEM’s cash and investments totaled $124.5 million. MTEM’s current cash and investments are expected to fund operations to the end of 2023.

For more details on MTEM’s financial results for the first quarter 2022, refer to Form 10Q filed with the SEC.

On May 12, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, LianBio, MAY 12, 2022, View Source [SID1234614312]).

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"LianBio continues to solidify our standing as the partner of choice to bring clinically validated therapeutic candidates to Greater China and other Asian markets," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Several of our partners have recently reached significant global milestones, including a U.S. FDA approval, positive pivotal trial results, and an acquisition. We congratulate our development partners on these important achievements. In China, we are committed to accelerating patient access to potentially transformative therapeutics, and we remain on track to complete enrollment in our ongoing Phase 3 EXPLORER-CN trial of mavacamten and to initiate three additional pivotal studies this year."

Recent Business Highlights and Clinical Development Updates

BMS receives FDA approval for mavacamten and presents additional positive Phase 3 clinical trial results

In April 2022, LianBio’s partner Bristol Myers Squibb (BMS) presented data from two clinical trials of mavacamten at the American College of Cardiology 71st Annual Scientific Session. Data from the EXPLORER-LTE clinical trial demonstrated sustained improvements in clinically meaningful cardiovascular outcomes at weeks 48 and 84 in patients with symptomatic oHCM receiving mavacamten. Data from the Phase 3 VALOR-HCM clinical trial demonstrated the addition of mavacamten significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic oHCM who had been appropriate for SRT at baseline.

In April 2022, BMS announced the U.S. Food and Drug Administration (FDA) approval of mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM to improve functional capacity and symptoms.
Mavacamten development progress continues in China

In January 2022, LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM. Patient enrollment is ongoing.

In February 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with oHCM.

In May 2022, LianBio announced topline results from the Phase 1 pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. A single oral administration of mavacamten in Chinese healthy adult subjects showed no new safety signals. The data demonstrated a favorable PK, safety and tolerability profile comparable to that observed in the Phase 1 pharmacokinetic study of mavacamten conducted by LianBio’s partner, MyoKardia, now a wholly owned subsidiary of BMS, in healthy volunteers in the United States.
TP-03 met all primary and secondary endpoints in Tarsus’s second U.S. pivotal trial

In May 2022, Tarsus announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in Demodex blepharitis (DB) patients. The clinical trial met all primary and secondary endpoints and TP-03 was well-tolerated.

Based on these data, Tarsus announced that it will submit a New Drug Application to the U.S. FDA in the second half of 2022.
Development partner ReViral Ltd. entered into definitive agreement to be acquired by Pfizer Inc.

In April 2022, Pfizer and ReViral entered into a definitive agreement under which Pfizer will acquire ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir.
Formation of Scientific Advisory Board

In April 2022, LianBio formed a Scientific Advisory Board (SAB). The LianBio SAB is comprised of industry leaders in global drug development who are serving as strategic advisors to the Company.
Appointment to the Board of Directors

In April 2022, LianBio appointed Wei Wei Chen to the Board of Directors. Ms. Chen brings over 17 years of experience serving as chief financial officer of companies in the consumer, retail and healthcare sectors.
Business is well-positioned to achieve anticipated milestones

Current cash runway is projected to extend through mid-2024.
Key Milestones Anticipated in 2022

Mavacamten

Enrollment is ongoing in the EXPLORER-CN Phase 3 clinical trial of mavacamten in Chinese patients with oHCM. LianBio expects to complete enrollment in the second half of 2022.
TP-03

LianBio remains on track to initiate a Phase 3 clinical trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
NBTXR3

LianBio expects to begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
Infigratinib

Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

LianBio expects to begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
First Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $12.3 million for the first quarter of 2022 compared to $53.4 million for the first quarter of 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.

General & Administrative Expenses
General and administrative expenses were $16.1 million for the first quarter of 2022 compared to $7.1 million for the first quarter of 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.

Net Loss
Net loss was $27.7 million for the first quarter of 2022 compared to net loss of $61.6 million for the first quarter of 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2022 totaled $389.1 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through mid-2024.

On May 12, 2022 AbbVie (NYSE: ABBV) reported that it will present 46 abstracts across eight types of cancer during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (June 3-7) and the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 9-17) (Press release, AbbVie, MAY 12, 2022, View Source [SID1234614329]).

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"AbbVie continues working to transform the standards of care for cancer treatments as a result of our commitment to patients, innovation and partnerships," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "The data being presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will provide a look at our continued research advancements in cancer across our expanding oncology portfolio and pipeline."

During both meetings, AbbVie will present nine abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, including data from multiple arms of the ongoing phase 1b/2 EPCORE NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL). Additionally, data will be presented from the Phase 2 REFINE study of investigational compound navitoclax + ruxolitinib in JAK inhibitor-treatment-naïve patients with myelofibrosis.

At this year’s ASCO (Free ASCO Whitepaper) annual meeting AbbVie will be presenting on its solid tumor research with data from telisotuzumab vedotin (Teliso-V) in non-small cell lung cancer.

During the EHA (Free EHA Whitepaper) Congress, the five-year update from the CLL14 trial of a combined regimen of venetoclax + obinutuzumab versus obinutuzumab + chlorambucil comparing the efficacy and safety in participants with untreated chronic lymphocytic leukemia (CLL) will be presented.

Details about presentations are as follows:

ASCO 2022 Abstracts

Abstract

Presentation Details

All Times in CT

Ibrutinib

Primary Results From the Double-Blind,
Placebo-Controlled, Phase III SHINE Study of
Ibrutinib in Combination With Bendamustine-
Rituximab (BR) and R Maintenance as a
First-Line Treatment for Older Patients (Pts)
with Mantle Cell Lymphoma (MCL)

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Friday, June 3, 2022

1:00 – 4:00 p.m. CT

Oral

Fixed-Duration (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(tx) of Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL)
3-year Follow-up From the FD Cohort of the
Phase 2 CAPTIVATE Study

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Phase 1/2 Study of Zilovertamab and Ibrutinib
in Mantle Cell Lymphoma (MCL) or Chronic
Lymphocytic Leukemia (CLL)

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

3:00 – 4:30 p.m. CT

Poster

Prognostic Testing and Treatment Patterns in
Black Patients (Pts) With Chronic
Lymphocytic Leukemia (CLL) From the
Inform CLL Prospective
Observational Registry

Abstract Publication Only

Upper Gastrointestinal (GI) Morbidity, Peptic
Ulcer Risk, and Proton Pump Inhibitor
(PPI)/H2 Blocker (H2B) Use in Patients (Pts)
Treated With Bruton’s Tyrosine Kinase
Inhibitors (BTKis) During Routine Care

Abstract Publication Only

Characteristics and Clinical Outcomes
Among Patients Receiving Either Ibrutinib or
Anti-CD20 Monotherapy as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis in Community
Oncology Practice

Abstract Publication Only

Real-World Clinical Outcomes in Patients
Receiving Either Ibrutinib or Chemo-
Immunotherapy (CIT) as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis

Abstract Publication Only

Venetoclax

Efficacy and Safety of Venetoclax
in Combination With Azacitidine or Decitabine in
an Outpatient Setting in Patients with
Untreated Acute Myeloid Leukemia

Session: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab*

First-Line Treatment (Tx) With Subcutaneous
(SC) Epcoritamab (Epco) + R-CHOP in
Patients (Pts) With High-Risk Diffuse Large
B-Cell Lymphoma (DLBCL): Phase 1/2 Data
Update

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab With Rituximab +
Lenalidomide (R2) in Patients (Pts) with
Relapsed or Refractory (R/R) Follicular
Lymphoma (FL): Update from Phase 1/2 Trial

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab + R-DHAX/C in
Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) Who Are Eligible for Autologous
Stem Cell Transplant (ASCT): Preliminary
Phase 1/2 Results

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab (Epco) with Gemcitabine +
Oxaliplatin (GemOx) in Patients (Pts) With
Relapsed or Refractory (R/R) Diffuse Large
B‑Cell Lymphoma (DLBCL) Ineligible for
Autologous Stem Cell Transplant (ASCT)
Induces High Response Rate Even in Pts
Failing CAR T Therapy

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Navitoclax

Navitoclax Plus Ruxolitinib in JAK inhibitor-
Naïve Patients (Pts) With Myelofibrosis:
Preliminary Safety and Efficacy in a
Multicenter, Open-Label Phase 2 Study

Session: Hematologic Malignancies –
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

8:00 – 11:00 a.m. CT

Poster

Saturday, June 4, 2022

1:15 – 2:45 p.m. CT

Poster Discussion

Lemzoparlimab

Lemzoparlimab (Lemzo) with Venetoclax
(Ven) and/or Azacitidine (Aza) in Patients
(Pts) With Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS)
A Phase 1b Dose Escalation Study

Session: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Teliso-V

Phase 1/1B study of Telisotuzumab Vedotin
(Teliso-V) + Osimertinib (Osi), After Failure
on Prior Osi, in Patients (Pts) With Advanced,
c-Met Overexpressing, EGFR-Mutated Non-
Small Cell Lung Cancer (NSCLC).

Session: Lung Cancer – Non-Small Cell
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Discussion

Telisotuzumab Vedotin (Teliso-V)
Monotherapy in Patients (Pts) With
Previously Treated c-Met-Overexpressing
(OE) Advanced Non-Small Cell Lung Cancer
(NSCLC)

Session: Lung Cancer – Non-Small Cell
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Discussion

The ASCO (Free ASCO Whitepaper) 2022 Annual Meeting abstracts are available here.

EHA 2022 Abstracts

Abstract

Presentation Details

All Times in CT

Ibrutinib

Immune Restoration and Synergistic Activity
with First-Line (1L) Ibrutinib (IBR) Plus
Venetoclax (VEN): Translational Analyses of
CAPTIVATE Trial Patients with CLL

Session: CLL: Translational Research

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Primary Results From the Phase 3 Shine Study
of Ibrutinub in Combination With
Bendamustine-Rituximab (BR) and R
Maintenance as a First-Line Treatment for
Older Patients With Mantle-Cell Lymphoma

Session: Indolent and Mantle Cell Lymphoma

Saturday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

Absence of BTK, BCL2, and PLCG2 Mutations
in Relapsing Chronic Lymphocytic Leukemia
(CLL) After First-Line Treatment with Fixed-
Duration Ibrutinib (I) Plus Venetoclax (V)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30-10:45 a.m. CT

Poster

Fixed-Duration (FD) Ibrutinib + Venetoclax for
First-Line Treatment of Chronic Lymphocytic
Leukemia (CLL)/Small Lymophocytic
Lymphoma (SLL): 3-Year Follow-up From the
Phase 2 CAPTIVATE Study FD Cohort

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Cross-Trial Analysis of Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Vs Fludarabine (F),
Cyclophosphamide (C), And Rituximab (R) As
First-Line Treatment for Chronic Lymphocytic
Leukemia (CLL)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Abstract Publication Only

Venetoclax***

Venetoclax-Obinutuzumab for Previously
Untreated Chronic Lymphocytic Leukemia: 5-
Year Results of the Randomized CLL14 Study

Session: CLL: Clinical

Sunday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

VIALE-M: A Randomized, Double-Blind, 2-Arm,
Multicenter, Phase 3 Study of Venetoclax and
Oral Azacitidine Versus Oral Azacitidine as
Maintenance Therapy for Patients With Acute
Myeloid Leukemia in First Remission After
Intensive Chemotherapy

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

VIALE-T: A Randomized, Open-Label, Phase 3
Study of Venetoclax in Combination With
Azacitidine After Allogeneic Stem Cell
Transplantation in Patients With Acute Myeloid
Leukemia

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

The Impact of Post-Remission Granulocyte
Colony-Stimulating Factor Use in the Phase 3
Studies of Venetoclax Combination Treatments
in Patients With Newly Diagnosed Acute
Myeloid Leukemia

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Transfusion Independence Among Newly
Diagnosed Acute Myeloid Leukemia Patients
Receiving Venetoclax-Based Combinations Vs
Other Therapies: Results from the AML Real
World Evidence (ARC) Initiative

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Clinical Outcomes in Patients With
Higher-Risk Myelodysplastic Syndromes
Receiving Hypomethylating Agents:
a Large Population-Based Analysis

Session: Myelodysplastic syndromes – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Patients With Chronic
Lymphocytic Leukemia With 17p Deletion: 6-
Year Follow-Up and Genomic Analyses in a
Pivotal Phase 2 Trial

Session: CLL: Clinical

Friday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

Treatment Sequences and Outcomes of
Patients (Pts) with CLL Treated With Targeted
Agents in Real-World Settings

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Healthcare Resource Utilization and Costs Of
Therapy With Fixed-Duration Venetoclax
Among CLL Patients (Pts)

Abstract Publication Only

Transcriptomic Characterization of MRD
Response and Non-Response in Patients (Pts)

Treated With Fixed-Duration Venetoclax-
Obinutuzumab

Session: CLL: Translational

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Fixed-Duration (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(Tx) of Chronic Lymphocytic Leukemia (CLL) /
Small Lymphocytic Lymphoma (SLL): 3-Year
Follow-Up From the FD Cohort of the Phase 2
CAPTIVATE Study

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

PedAL/EuPAL International Collaboration to
Improve the Outcome of Children With
Relapsed or Refractory Acute Myeloid
Leukemia (AML)

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Cross-Trial Analysis of Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Versus Fludarabine (F),
Cyclophosphamide (C), and Rituximab (R) as
First-Line Treatment for Chromic Lymphoma
Leukemia (CLL)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Abstract Publication Only

Safety and Effectiveness of Venetoclax
Monotherapy in Relapsed/Refractory CLL
Patients (Pts) With or Without Risk-Associated
Genetic Markers – Data from the Observational
VeRVe Study

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Effectiveness and Safety of Venetoclax in
Combination with Rituximab (VenR) in
Relapsed/Refractory CLL Patients With or
Without Risk-Associated Genetic Markers –
Data from the Observational VeRVe Study

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Real-Life Efficacy and Safety of Venetoclax
Monotherapy in Relapsed/Refractory Chronic
Lymphocytic Leukemia – Interim Analysis of
Multicentric Study VERONE

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Combination With Obinutuzumab
in First Line Chromic Leukemia in Argentina: A
Cost-Effectiveness Analysis

Session: Quality of life, palliative care, ethics
and health economics
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Lemzoparlimab**

Lemzoparlimab (Lemzo) With Venetoclax (Ven)
And/Or Azacitidine (Aza) in Patients (Pts) With
Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS): A Phase
1b Dose Escalation Study

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab*

Assessing Safety, Tolerability, and Efficacy of
Subcutaneous Epcoritamab in Novel
Combinations With Anti-Neoplastic Agents in
Patients (Pts) With Non-Hodgkin Lymphoma in
an Open-Label Phase 1B/2 Study

Session: Aggressive Non-Hodgkin lymphoma
– Clinical
Abstract Publication Only

Subcutaneous (SC) Epcoritamab + R-CHOP in
Previously Untreated Patients (Pts) With High-
Risk Diffuse Large B-Cell Lymphoma (DLBCL):
Phase 1/2 Data Update

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Subcutaneous (SC) Epcoritamab With
Rituximab + Lenalidomide (R2) in Patients
(Pts) With Relapsed or Refractory (R/R)
Follicular Lymphoma (FL): Update From Phase
1/2 Trial

Friday, June 10, 2022

4:30 – 5:45 p.m. CT

Poster

Subcutaneous (SC) Epcoritamab + R-DHAX/C
in Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Who Are Eligible For Autologous Stem Cell
Transplant (ASCT): Preliminary Phase 1/2 Data

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab With Gemcitabine + Oxaliplatin
(GemOx) in Patients (Pts) With Relapsed or
Refractory (R/R) Diffuse Large B Cell
Lymphoma (DLBCL) Who Are Ineligible for
Autologous Stem Cell Transplant (ASCT):
Phase 1/2 Data

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax

Navitoclax Monotherapy in Patients (Pts) With
MF Previously Treated With JAK-2 Inhibitors:
Safety and Tolerability

Session: Myeloproliferative neoplasms – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax plus ruxolitinib in JAK Inhibitor-naïve
Patients with Myelofibrosis: Preliminary Safety
and Efficacy in a Multicenter, Open-label Phase
2 Study

Session: Treatments and complications in MPN
Friday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

The EHA (Free EHA Whitepaper) 2022 Congress abstracts are available here.

*Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.

**Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

***Use of venetoclax in myelodysplastic syndromes (MDS) is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Ibrutinib (IMBRUVICA)
IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc. IMBRUVICA blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, to multiply and spread.1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.3

IMBRUVICA is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 ongoing or completed Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA.

IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include adults with CLL/small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p) and adults with Waldenström’s macroglobulinemia (WM), as well as adult patients with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.4

*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Since 2019, the National Comprehensive Cancer Network (NCCN), recommends ibrutinib (IMBRUVICA) as a preferred regimen for first-line treatment of CLL/SLL, with Category 1 status for previously untreated patients without del17p. Additionally, IMBRUVICA is a preferred treatment regimen for previously untreated patients with del17p. Since January 2020, the NCCN Guidelines recommend IMBRUVICA as a category 2A preferred regimen for the treatment of relapsed/refractory MCL. Since September 2020, the NCCN Guidelines recommend IMBRUVICA with or without rituximab as a Category 1 preferred regimen for both untreated and previously treated WM patients.

For more information, visit www.IMBRUVICA.com.

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Side Effect Information5
Before taking IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
have bleeding problems.
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
have an infection.
have liver problems.
are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA and for 1 month after the last dose.
Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA and for 1 month after the last dose.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.

How should I take IMBRUVICA?

Take IMBRUVICA exactly as your healthcare provider tells you to take it.
Take IMBRUVICA 1 time a day.
Swallow IMBRUVICA capsules or tablets whole with a glass of water.
Do not open, break or chew IMBRUVICA capsules.
Do not cut, crush or chew IMBRUVICA tablets.
Take IMBRUVICA at about the same time each day.
If you miss a dose of IMBRUVICA take it as soon as you remember on the same day. Take your next dose of IMBRUVICA at your regular time on the next day. Do not take extra doses of IMBRUVICA to make up for a missed dose.
If you take too much IMBRUVICA call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking IMBRUVICA?

You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.
What are the possible side effects of IMBRUVICA?
IMBRUVICA may cause serious side effects, including:

Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA dose.
High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs.
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
The most common side effects of IMBRUVICA in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

diarrhea
tiredness
muscle and bone pain
rash
bruising
The most common side effects of IMBRUVICA in adults with cGVHD include:

tiredness
bruising
diarrhea
mouth sores (stomatitis)
muscle spasms
nausea
pneumonia
Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.

Please click here for full Prescribing Information.5

About VENCLEXTA/VENCLYXTO (venetoclax)6

VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Important Safety Information7

What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions,
including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. 

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. 

Indications and Important Venclyxto (venetoclax) EU Safety Information8

Indications

VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

VENCLYXTO monotherapy is indicated for the treatment of CLL:

In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as Venclyxto efficacy may be reduced.

Special Warnings & Precautions for Use

Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).

Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase. During postmarketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax.

Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period.

In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.

For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment, including antimicrobials and dose interruption or reduction as appropriate.

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions

In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

CYP3A4 inducers may decrease Venclyxto plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

Adverse Reactions

CLL

The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently occurring serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.

Discontinuations due to adverse reactions occurred in 16% of patients in both combination studies (CLL14 and MURANO). In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.

Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in the CLL14 study, in 15% of patients treated with the combination of venetoclax and rituximab in the Murano study, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.

AML

The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

Discontinuations due to adverse reactions occurred in 24 % of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65 % of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia. The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

Special Populations

Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

This is not a complete summary of all safety information. See Venclyxto (venetoclax) SmPC at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.9 Epcoritamab was developed with selective, silencing mutations that may limit, systemic non-specific activity.10 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.11,12 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.

About Lemzoparlimab
Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway.13 Navitoclax is not approved by any regulatory authority. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie is currently recruiting for two Phase 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with ruxolitinib for the treatment of myelofibrosis that will enroll more than 500 patients. The company anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.

About Telisotuzumab Vedotin
Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy are under evaluation.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit View Source