On May 12, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period ended March 31, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, MAY 12, 2022, View Source [SID1234614332]).

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"We anticipate FDA approvals later this year for poziotinib and eflapegrastim. In the first quarter, we initiated a confirmatory study and presented additional positive scientific data for poziotinib. The resubmitted BLA for eflapegrastim was also accepted for review by the FDA," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are proud of the progress we’ve made toward our core business objectives and we remain dedicated to making a meaningful difference in the lives of cancer patients."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The U.S. Food and Drug Administration (FDA) has accepted Spectrum’s resubmitted Biologics License Application (BLA) for eflapegrastim with a Prescription Drug User Fee Act (PDUFA) date of September 9, 2022. The company is working with its partner, Hanmi Pharmaceutical, to support the FDA regulatory review process.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20 mutations

The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation. The NDA is based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The agency has set a PDUFA date of November 24, 2022. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
A study for poziotinib has been initiated to confirm the clinical benefit seen in Cohort 2, as required for an accelerated approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to enroll 268 patients with previously treated NSCLC harboring HER2 exon 20 mutations. Patients are being randomized 2-to-1 into one of two treatment arms using 8mg of poziotinib orally administered BID (twice daily) versus 75mg/m2 of docetaxel administered intravenously every three weeks. The primary endpoint will be Progression Free Survival.
FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The fall ODAC meeting is being held September 22-23, 2022. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. As usual, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Data from Cohort 4 of the ZENITH20 study in patients with treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations were presented in an oral session at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022. The results showed a confirmed objective response rate (ORR) of 41%, as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the tyrosine kinase inhibitor (TKI) class. Notably, on-target adverse events (AEs) were meaningfully reduced with BID dosing.
The company presented a poster on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Preliminary results suggest that decreases in plasma ctDNA during poziotinib therapy correlate with clinical response in patients with advanced NSCLC with HER2 exon 20 insertion mutations. Additional data from this study will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in early June.
Corporate Updates

Nora E. Brennan was named Chief Financial Officer effective May 25, 2022. Ms. Brennan has served on Spectrum’s Board of Directors since December 2020 and as Chair of the Audit Committee. She will relinquish her board duties to assume her new senior leadership role. Most recently, Ms. Brennan served as Chief Financial Officer of Fore Biotherapeutics, a developer of cancer therapies driven by functional genomics. Prior to Fore, she served as Chief Financial Officer at TELA Bio, Inc. and as Senior Vice President of Treasury and Investor Relations at Integra Life Sciences Holdings Corporation.
Hanmi Pharmaceutical completed a $20 million strategic equity investment in Spectrum in January 2022, which included revisions to the licensing and supply agreements for eflapegrastim and poziotinib.
Two new members of the Board of Directors have been named. In March, Juhyun Lim was appointed to the Board. Ms. Lim currently serves as President, Global Strategy and Planning at Hanmi Science and Hanmi Pharmaceutical, where she leads the execution of corporate strategy and investment. In May, Spectrum named Brittany Bradrick to the Board and she will succeed Ms. Brennan as Chair of the Audit Committee. Ms. Bradrick currently serves as Chief Financial Officer of Neurelis, Inc. Ms. Bradrick is a seasoned executive with 25 years of experience in the life sciences sector including in the areas of mergers and acquisitions, investment banking, finance, strategy and corporate development.
A strategic restructuring with a ~30% staff reduction and ~20-25% reduction in operating cash burn was initiated in January 2022 to focus the company’s development activities on its late-stage assets, poziotinib and eflapegrastim. Development activities for the early-stage pipeline has been deprioritized.
Three-Month Period Ended March 31, 2022 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $15.4 million, or a $0.09 loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a net loss of $35.7 million, or a $0.25 loss per basic and diluted share, in the comparable period in 2021. Total research and development expenses were $4.2 million in the quarter, as compared to $19.4 million in the same period in 2021. Selling, general and administrative expenses were $9.9 million in the quarter, compared to $14.3 million in the same period in 2021.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $9.6 million, or a $0.06 non-GAAP loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a non-GAAP net loss of $29.4 million, or a $0.20 non-GAAP loss per basic and diluted share, in the comparable period in 2021. Non-GAAP research and development expenses were $2.1 million, as compared to $18.0 million in the same period of 2021. Non-GAAP selling, general and administrative expenses were $7.5 million, as compared to $11.5 million in the same period in 2021.

Cash Position and Guidance

In January, the company received a $20 million strategic equity investment from Hanmi Pharmaceutical. Together with this strategic investment, Spectrum ended the quarter with cash, cash equivalents, and marketable securities of approximately $89.2 million. The additional cash, combined with the restructuring, is expected to extend the company’s cash runway into 2023.

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on May 12, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On May 12, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present new preclinical data highlighting the anti-tumor activity of Wugen’s lead memory natural killer (NK) product candidate WU-NK-101 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress being held June 9-12, 2022, virtually and in-person in Vienna, Austria (Press release, Wugen, MAY 12, 2022, View Source [SID1234614331]).

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The data highlight preclinical activity of WU-NK-101 supporting its clinical development for acute myeloid leukemia (AML). WU-NK-101 displayed activity against AML cell lines both in vitro and in vivo, and improved homing to the bone marrow. Further, the functional characteristics of WU-NK-101 support the potential development of WU-NK-101 for solid tumors, with data showing resistance to an adverse and immunosuppressive tumor microenvironment (TME).

The details of Wugen’s poster presentation at EHA (Free EHA Whitepaper) are as follows:

Title: WU-NK-101, An Allogeneic Memory NK Cell, for the Treatment of Relapse or Refractory (R/R) Acute Myeloid Leukemia (AML)
Session date and time: Friday, June 10, 2022, from 4:30 – 5:45 p.m. CEST
Abstract Number: P1426
Presenting Author: Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer, Wugen

Additional meeting information can be found at www.ehaweb.org/congress

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On May 12, 2022 ADC Therapeutics SA (NYSE: ADCT), reported that results from the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma have been accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA2022), which will be held virtually and in Vienna, Austria from June 9-12, 2022 (Press release, ADC Therapeutics, MAY 12, 2022, View Source [SID1234614330]).

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"We continue to be encouraged by the data from our ongoing pivotal Phase 2 trial demonstrating the efficacy and safety of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "As we advance Cami toward a potential BLA submission, we look forward to sharing these data with the hematology community at EHA (Free EHA Whitepaper)2022."

Details of ADC Therapeutics’ oral presentation are as follows:

Camidanlumab Tesirine: Updated Efficacy And Safety In An Open-Label, Multicenter, Phase 2 Study Of Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma (R/R CHL)Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Session Title: Hodgkin lymphoma – Clinical

Session Room: Hall A8

Abstract Code: S201

Presenter: Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy

Details of ADC Therapeutics’ poster presentations are as follows:

Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2)

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: P1717

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1182

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST – 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1181

Titles of ADC Therapeutics’ abstracts accepted for publication only are as follows:

·A Phase 2, Open-Label Study Of Loncastuximab Tesirine In Combination With Rituximab (LONCA-R) In Previously Untreated Unfit/Frail Patients With Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-9) [Trials in progress]

·Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)

·Phase 3 Randomized Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With R/R DLBCL (LOTIS-5) [Trials in progress]

Please note: times and locations are tentative and subject to change.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

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

On May 12, 2022 Paige, a global leader in clinical AI applications in pathology, reported it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software that is designed to detect the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin (H&E)* (Press release, Paige AI, MAY 12, 2022, View Source [SID1234614328]). This is the first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples for Paige, potentially expanding the utility of AI to analyze tissues prepared with the most frequently used stain in histology.

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In contrast to traditional molecular biomarker testing, image-based biomarkers can enable faster turnaround time for results, provide new information at the point of diagnosis and reduces the need for unnecessary and expensive testing on definite negatives, while protecting the integrity of the tissue sample. Specifically, the Paige Prostate Biomarker Suite can detect biomarkers from H&E-stained samples and can inform the need for confirmatory tests such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).

The Paige Prostate Biomarker Suite is designed to assist in the detection of Androgen Receptor (AR), TP53, RB1 and PTEN biomarkers that are associated with the development and progression of prostate cancer. The biomarkers can help physicians stratify patients into treatment paradigms and direct targeted enrollment into clinical trials. The Paige Prostate Biomarker Suite was developed using the same underlying technology from Paige Prostate Detect, which was developed with histology image data from tens of thousands of patients and is already CE-IVD and UKCA marked, in addition to being approved by the FDA in the U.S.

"By employing Paige Prostate Biomarker Suite, clinicians can rapidly reduce laboratory turnaround time while providing a broader range of data at the point of diagnosis," said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. "We’re excited by this regulatory milestone of our biomarker capabilities built on our robust AI technology platform, which can rapidly screen and develop proof-of-concept biomarkers. As we expand our biomarker portfolio, we also look forward to developing novel biomarkers across indications to identify patients that should receive genomic testing or could potentially respond to targeted therapies. This opens the door to a whole new range of biomarker applications and, in turn, new opportunities for industry collaboration."

For more information about the Paige Prostate Biomarker Suite, contact [email protected].

*In the United States, Paige Prostate Biomarker Suite is available for Research Use Only and not for use in diagnostic procedures.