On May 15, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported it will present data from studies evaluating the BCL-2 inhibitor venetoclax (VENCLEXTA/ VENCLYXTO), among others, from clinical trials across multiple blood cancers at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, being held virtually from June 11-14, 2020 (Press release, AbbVie, MAY 15, 2020, View Source [SID1234558123]). These data will span the company’s investigational and approved oncology portfolio medicines across chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and myelofibrosis (MF).

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"We continue to demonstrate the broad utility of our oncology portfolio – anchored by VENCLEXTA/VENCLYXTO and IMBRUVICA – with new, longer-term and clinically meaningful results presented at this year’s EHA (Free EHA Whitepaper) meeting," said Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie. "We are excited to share these studies with the global oncology community as they reflect our ongoing commitment to improving care for patients with various difficult-to-treat blood cancers."

Researchers will present during EHA (Free EHA Whitepaper) data based on findings from the Phase 3 CLL14 trial evaluating venetoclax in combination with obinutuzumab in patients with previously-untreated CLL (abstract #S155). In March 2020, AbbVie announced the approval of venetoclax plus obinutuzumab in the European Union, based on data from the CLL14 trial.1 Additionally, several abstracts from studies of venetoclax in various tumor types will be presented, including:

Extended follow-up data from the Phase 3 MURANO trial on subgroup-analyses of venetoclax in combination with rituximab in relapsed/refractory CLL, including the impact of premature discontinuation/interruption of venetoclax on outcomes in these patients (abstracts #EP694 and #EP691)
New data on safety and efficacy will be featured from the CAPTIVATE study evaluating ibrutinib (IMBRUVICA) plus venetoclax in first-line treatment of CLL (abstract #S158)
Six-month update from the Phase 3 VIALE-C study of venetoclax in combination with low-dose cytarabine in previously untreated older patients with AML (abstract #S136)
AbbVie sponsored abstracts accepted by EHA (Free EHA Whitepaper) include:

Abstract

Session+

Ibrutinib

First-Line Ibrutinib (Ibr) + Venetoclax (VEN) For Patients (Pts) With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Efficacy And Safety Results From CAPTIVATE-MRD Study. Siddiqi et al. Abstract #S158

Oral Session: CLL – Targeted Therapy I

Ibrutinib Treatment For Pediatric Chronic Graft Versus Host Disease: A Prospective Phase 1/2 Study. Zecca et al. Abstract #EP1387

E-Poster Session: Stem Cell Transplantation – Clinical

Prognostic Biomarker Testing And Treatment Selections In Patients With Chronic Lymphocytic Leukemia Pre- And Post-Approval Of Novel Agents. Mato et al. Abstract #EP712

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Application Of iwCLL Guidelines For Response Assessment In The Treatment Of Patients With Chronic Lymphocytic Leukemia In The Real-World: An Analysis From The INFORMCLL Registry. Barrientos et al. Abstract #PB1908

Publication Only Abstract

Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Venetoclax in CLL

Extrapolating Progression Free Survival Curves In CLL Using Peripheral Blood MRD Measurements From Venetoclax Trials. Alexiou et al.; Abstract #EP708

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Efficacy of Venetoclax in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Primary Endpoint Analysis of the International Phase 3b Trial (VENICE I). Kater et al.; Abstract #S156

Oral Session: CLL – Targeted Therapy I

Impact of Venetoclax Monotherapy on The Quality of Life of Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Results from VENICE II Phase 3b Trial. Cochrane et al.; Abstract #EP701

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Phase 3b Study to Evaluate Debulking Regimens Prior to Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia. Sharman et al.; Abstract #EP687

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Neutropenia Analysis of Venetoclax Monotherapy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Pooled Data from VENICE-I and -II Phase 3b Trials. Anderson et al.; Abstract #EP718

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Fixed-Duration Venetoclax-Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Follow-Up of Efficacy and Safety Results from the Multicenter, Open-Label, Randomized, Phase 3 CLL14 Trial. Al-Sawaf et al.; Abstract #S155

Oral Session: CLL – Targeted Therapy I

Characteristics and Outcome of Patients with Chronic Lymphocytic Leukaemia and Partial Response to Venetoclax-Obinutuzumab. Al-Sawaf et al.; Abstract #EP699

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Impact of Premature Venetoclax (VEN) Discontinuation/Interruption on Outcomes in Relapsed/ Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 MURANO Study. Mato et al.; Abstract #EP691

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

Extended Follow-Up in BIRC3- Mutated Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients Treated With Fixed-Duration Venetoclax Plus Rituximab: Subgroup Analyses of the MURANO Trial. Kater et al.; Abstract #EP694

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

Systematic Literature Review and Network Meta-Analysis Comparing Therapies for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia. Sail et al.; Abstract #EP725

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

CLL2-GiVe, a Prospective, Open-Label, Multicenter Phase-2 Trial of Obinutuzumab (Ga101, G), Ibrutinib (I), Plus Venetoclax (Ve) in Untreated Patients with CLL With 17p Deletion / Tp53 Mutation. Huber et al.; Abstract #S157

Oral Session: CLL – Targeted Therapy I

Kinetics of Response in the Peripheral Blood Predicts Long Term Responses to Ibrutinib + Venetoclax Treatment for Relapsed/Refractory CLL in the Bloodwise TAP CLARITY trial. Rawstron et al.; Abstract #S164

Oral Session: CLL – Targeted Therapy II

Venetoclax in AML

Long-Term Follow Up: Phase 1b/2 Study of Venetoclax Plus Low-Dose Cytarabine in Previously Untreated Older Adults with Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy. Wei et al.; Abstract #EP554

E-Poster Session: Acute Myeloid Leukemia – Clinical

Timing of Response to Venetoclax Combination Treatment in Older Patients with Acute Myeloid Leukemia. Jonas et al.; Abstract #EP535

E-Poster Session: Acute Myeloid Leukemia – Clinical

Real-World Data (RWD) Cohort of Patients with Acute Myeloid Leukemia (AML) in the United States from an Electronic Health Record (EHR)–Derived De-Identified Database. Flahavan et al.; Abstract #EP600

E-Poster Session: Acute Myeloid Leukemia – Clinical

Transfusion Burden on Older Patients with Acute Myeloid Leukemia Receiving Low-Intensity Treatments. Le Blanc et al.; Abstract #EP1739

E-Poster Session: Quality of Life, Palliative & Supportive Care, Ethics and Health Economics

Phase 1b/2 Study of the IDH1-Mutant Inhibitor Ivosidenib with the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies. DiNardo et al.; Abstract #S143*

Oral Session: Acute Myeloid Leukemia – Clinical

A Phase 3 Study of Venetoclax Plus Low-Dose Cytarabine in Previously Untreated Older Patients with Acute Myeloid Leukemia (VIALE-C): A 6-Month Update. Wei et al.; Abstract #S136

Oral Session: AML Randomized Trials

Treatment Patterns and Outcomes of Newly Diagnosed Acute Myeloid Leukemia Patients Receiving Venetoclax Combinations Vs Other Therapies: Results from the AML Real World Evidence (ARC) Initiative. Talati et al. Abstract #PB1831

Publication Only Abstract

Acute Myeloid Leukemia – Clinical

First-In-Human Study of a TRAIL Receptor Agonist Fusion Protein, Eftozanermin Alfa, in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma. Jongen-Lavrencic et al. Abstract #EP589

E-Poster Session: Acute Myeloid Leukemia – Clinical

Venetoclax in MDS

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine for the Treatment of Relapsed/Refractory Myelodysplastic Syndrome. Zeidan et al.; Abstract #S188

Oral Session: Myelodysplastic Syndromes – Clinical

The Prognostic Impact of Cytogenetic Scores in Patients with Higher-Risk Myelodysplastic Syndrome Treated with Venetoclax and Azacitidine in a Phase 1 Study. Garcia et al.; Abstract #EP795

E-Poster Session: Myelodysplastic Syndromes – Clinical

Venetoclax in ALL

Safety and Efficacy of Venetoclax in Combination with Navitoclax in Adult and Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Jabbour et al.; Abstract #S116

Oral Session: Cellular, Antibody and Targeted Therapy

Venetoclax in MM

Updated Results from a Phase 1/2 Study of Venetoclax in Combination with Daratumumab and Dexamethasone, +/- Bortezomib, in Patients with Relapsed/Refractory Multiple Myeloma. Kaufman et al.; Abstract #EP940

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical

Updated Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination With Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Kumar et al.; Abstract #EP939

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical

Evaluation of Minimal Residual Disease in Relapsed/Refractory Multiple Myeloma Patients Treated with Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone: BELLINI Study Analyses. Moreau et al.; Abstract #EP975

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical

The EHA (Free EHA Whitepaper) 2020 Annual Congress abstracts are available at www.ehaweb.org.

AbbVie will also present data from 17 accepted abstracts during the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29-31, 2020, including studies of ibrutinib, venetoclax and veliparib.

About IMBRUVICA
IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company and Janssen Biotech, Inc. The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.2,3 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.4

Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström’s macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.5

IMBRUVICA is now approved in 99 countries and has been used to treat more than 195,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

In early 2019, the National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and it is the only Category 1 treatment for treatment-naïve patients without deletion 17p. In February 2020, the NCCN Guidelines were updated to elevate IMBRUVICA with or without rituximab from other recommended regimens to a preferred regimen for the treatment of relapsed/refractory MCL.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. 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 SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA in 27 clinical trials. Bleeding events, including bruising and petechiae, occurred in 39% of patients who received IMBRUVICA.

The mechanism for the bleeding events is not well understood.

Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA without antiplatelet or anticoagulant therapy experienced major hemorrhage. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA. Monitor for signs and symptoms of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: In 645 patients with B?cell malignancies who received IMBRUVICA as a single agent, Grade 3 or 4 neutropenia occurred in 23% of patients, Grade 3 or 4 thrombocytopenia in 8% and Grade 3 or 4 anemia in 3%, based on laboratory measurements.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,476 patients who received IMBRUVICA in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA in clinical trials. Grade 3 or greater hypertension occurred in 8% of patients. Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months).

Monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA as appropriate.

Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (4%), occurred among the 1,476 patients who received IMBRUVICA in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥30%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal pain (38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%).

The most common Grade ≥ 3 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia (8.2%), and hypertension (8.0%).

Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Co-administration of IMBRUVICA with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Dose modifications of IMBRUVICA may be recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if strong inhibitors are used short-term (e.g., for ≤ 7 days). See dose modification guidelines in USPI sections 2.4 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce recommended IMBRUVICA dose and monitor more frequently for adverse reactions of IMBRUVICA.

Please click here for full Prescribing Information.

About VENCLEXTA/VENCLYXTO (venetoclax)

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. VENCLEXTA/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 and other cancers.

VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

Uses and Important VENCLEXTA (venetoclax) U.S. Safety Information6

Uses
VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.

This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

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.

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.
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.
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 low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts; infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.

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. For more information, ask your healthcare provider or pharmacist.

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.

If you cannot afford your medication, contact www.medicineassistancetool.org for assistance.

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

Indication and Important VENCLYXTO (venetoclax) EU Safety Information7

Indication

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.
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 tumor lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as VENCLYXTO efficacy may be reduced.

Special Warnings & Precautions for Use

TLS, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week 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. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.

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

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

CYP3A inhibitors may increase VENCLYXTO plasma concentrations. 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, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: moderate or strong CYP3A inhibitors must be used, physicians should refer to the VENCLYXTO summary of product characteristics (SmPC) for dose adjustment recommendations.

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

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 treated with venetoclax in combination with obinutuzumab or rituximab in the CLL14 and Murano studies respectively. 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 CLL14 and in 15% of patients treated with the combination of venetoclax and in Murano and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.

Specific Populations

Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS. 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.

On May 15, 2020 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2020 (Press release, Cleveland BioLabs, MAY 15, 2020, View Source [SID1234558122]).

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Cleveland BioLabs reported a net loss of $(0.6) million, excluding minority interests, for the first quarter of 2020, or $(0.05) per share, compared to a net loss, excluding minority interests, of $(0.9) million, or $(0.08) per share, for the same period in 2019 The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a increase in the non-cash adjustment to our warrant liabilities.

As of March 31, 2020, the Company had $1.4 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into August 2020.

Further Financial Results

Revenue for the first quarter of 2020 decreased to $0.16 million compared to $0.20 million for the first quarter of 2019. The net decrease was primarily attributable to decreased revenue from our service contract with Incuron, partially offset by increased revenue from our Peer Reviewed Medical Research Program ("PRMRP") and Joint Warfighter Medical Research Program ("JWMRP") contracts from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the first quarter of 2020 decreased to $0.2 million compared to $0.5 million for the first quarter of 2019. The reduction in research and development costs is due to a $0.17 million decrease in spending for biodefense applications of entolimod, and a $0.11 million decrease in expenses related to curaxins.

General and administrative costs for the first quarter of 2020 decreased to $0.38 million compared to $0.47 million for the first quarter of 2019. This decrease was primarily attributable to a $0.13 million decrease in CBLI’s personnel and professional fees and a $.03 million decrease in facilities costs, partially offset by a $0.10 million increase CBLI’s property taxes compared to the quarter ended March 31, 2019, when we received a property tax refund.

On May 15, 2020 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported financial results for the first quarter ended March 31, 2020 and provided an update on its clinical and operational progress (Press release, IMV, MAY 15, 2020, View Source [SID1234558121]).

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"Despite the current pandemic, we have continued to validate our platform and advance our clinical pipeline targeting various cancers and other serious diseases, including COVID-19," said Frederic Ors, Chief Executive Officer at IMV. "Today, we are especially pleased to announce that SPiReL, a Phase 2 study of a DPX-Survivac combination regimen in patients with r/r DLBCL, has met its primary efficacy endpoint. This represents a significant milestone for DPX-Survivac, which has so far demonstrated the ability to shrink both solid and hematological tumors with long-lasting clinical responses and a differentiated safety profile. We believe these results in r/r DLBCL, taken together with emerging data from our DeCidE1 study in advanced ovarian cancer, support our plan to accelerate development in both of these indications."

Mr. Ors continued, "Our recent financing fortifies our corporate position, with cash to fund operations for more than 12 months and several milestones anticipated across our portfolio in the interim. We look forward to presenting translational and updated clinical response data from DeCidE1 at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, and to further updates from each of our Phase 2 studies of DPX-Survivac later this year. Additionally, we are preparing to advance a DPX-based vaccine candidate for COVID-19, which is on track to enter into clinical trials later this summer."

DPX-Survivac Clinical Program Updates

Phase 2 SPiReL Study in Recurrent / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

The study has met its primary efficacy endpoint with 64% (7/11) of evaluable patients demonstrating a clinical response so far. The study remains ongoing and the top line data are expected to be presented at a conference later in 2020.

In December 2019, updated clinical results were reported in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, FL. At the time of this presentation, 17 subjects were enrolled in the study, of which nine (9/17) were evaluable. At that time, three (3/9) complete responses (CR) and two partial responses (PR) had been observed, with an overall response rate (ORR) of 59% (5/9).

As of May 7, 2020, 20 patients have been enrolled across five different clinical sites in Canada.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

In February, IMV reported interim data from this study, including:

15/19 (79%) evaluable subjects demonstrated disease control, including 10 tumor regressions (53%);

7/19 subjects (37%) achieved clinical benefit with partial response or stable disease lasting > 6 months; and

Treatment was well-tolerated with majority of adverse events being grade 1-2 reactions at the injection site.

At the time of the data cutoff, six (31%) patients remained on therapy. Five (26%) of these patients were still on treatment at > 6 months. Additional data are available here.

An abstract has been selected for a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, which will be held May 29–31, 2020. The poster presentation by Oliver Dorigo, MD, Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, Stanford, CA will provide translational data and an update on clinical responses and their duration.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of May 7, 2020, a total of 92 patients out of the planned 184 patients were enrolled across all five indications at 19 clinical sites in Canada and the US.

The COVID-19 pandemic has impacted data collection and validation processes and IMV now anticipates reporting updated results from this study in the second half of 2020.

DPX-COVID-19 Vaccine Program Update

In early March, IMV announced plans to develop a DPX-based vaccine candidate for COVID-19 in collaboration with experts in the field. IMV is on schedule to complete preclinical studies before the end of May and is on track to initiate a Phase 1 clinical study for DPX-COVID-19 this summer.

Since this update, IMV has met with Health Canada in preparation for its clinical trial application (CTA) and is in the process of finalizing its Phase 1 design. The randomized, placebo-controlled study will enroll approximately 84 healthy subjects in two age strata and will assess two different doses of DPX-COVID-19. IMV has also submitted to relevant authorities’ requests for grants for its DPX-COVID-19 program.

IMV will provide regular updates on the development of DPX-COVID-19 and more information can be found on the dedicated DPX-COVID-19 page on the Company’s website.

Update on Business and Clinical Operations in the Context of COVID-19 Pandemic

IMV continues to closely monitor the COVID-19 pandemic and adapt its business operations while prioritizing the health and well-being of patients, clinical investigators, and personnel. In accordance with recommendations from health authorities, IMV has transitioned to a remote working arrangement to protect employees and the broader community while maintaining business continuity. All clinical trial sites remain open and active with a heightened focus on patient safety and data integrity. While the effects of the pandemic are expected to slow the pace of patient recruitment due to the diversion of healthcare resources to COVID-19 response activities, they have not had a material impact on the Company’s financial condition, liquidity, or longer-term strategic development plans.

To date, the COVID-19 pandemic has impacted data collection and validation processes and as outlined above, this has delayed the planned readout from the Phase 2 basket study of DPX-Survivac/CPA in combination with Keytruda. The Company continues to monitor this situation and will provide regular updates in the future.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

Initiation of Phase 1 clinical trial for DPX-COVID-19 in the summer of 2020

Top line Phase 2 clinical results update in the DLBCL combination trial in 2020

Update on the Phase 2 clinical results in the ovarian monotherapy trial at ASCO (Free ASCO Whitepaper) 2020

Updated Phase 2 clinical results for Basket trial in 2H 2020.

Overview of Q1 2020 Financial Results

Research and development expenses increased by $2,811,000 for the quarter ended March 31, 2020, compared to Q1 2019. These increases are mainly due to a spike in enrollment prior to the onset of the pandemic related to the ongoing basket trial and non-recurring purchases of GMP grade raw materials and contract manufacturing for DPX-Survivac. The purchases of GMP grade materials in 2019 and Q1 2020 covers all the needs of the Corporation for ongoing DPX-Survivac trials until mid-2021. The increase in research and development expenses is, to a lesser extent, also attributable to preclinical development of DPX-SurMAGE for bladder cancer and personnel costs due to an increase in headcount.

General and administrative expenses increased by $1,073,000 for the quarter ended March 31, 2020 compared to Q1 2019. This increase is mainly due to non-cash DSU compensation caused by share price fluctuation, foreign exchange loss, and investor relations activities, including travel costs incurred prior to the start of the COVID-19 pandemic. The Company expects reduced comparative volatility in the DSU compensation expense from Q3 2020 onward as a result of electing to settle all future DSU redemptions in shares effective August 8, 2019.

The net loss and comprehensive loss of $9,664,000 ($0.19 per share) the quarter ended March 31, 2020 was $3,721,000 higher than the net loss and comprehensive loss for the quarter ended March 31, 2019.

At March 31, 2020, the Corporation had cash and cash equivalents of $7,372,000 and working capital of $4,553,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This does not reflect the proceeds from the CDN $25,100,000 private placement completed on May 7th, 2020 or utilization of the ATM Distribution subsequent to the period end date. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than 12 months.

For the quarter ended March 31, 2020, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $8,646,000. IMV expects the cash burn for the remainder of 2020 to return to $5-6,000,000 per quarter due to the impact of COVID-19 and the non-recurring expenditures incurred in Q1 2020.

As of May 14, 2020, the number of issued and outstanding common shares was 60,454,474 and a total of 5,079,375 stock options, deferred share units and warrants were outstanding.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended March 31, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host conference call and webcast today, May 15, 2020 at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 8081886 Other interested parties will be able to access the live audio webcast at this link: View Source

On May 15, 2020 NuCana plc (NASDAQ:NCNA) reported that two abstracts describing non-clinical studies related to the mechanisms of action of its proprietary ProTides, Acelarin (NUC-1031) and NUC-3373, were selected for poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting 2020 on June 22-24, 2020 (Press release, Nucana BioPharmaceuticals, MAY 15, 2020, View Source [SID1234558115]).

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In prior non-clinical studies, Acelarin has shown an ability to cause cancer-cell death via DNA damage. These new in vitro data presented at AACR (Free AACR Whitepaper) suggest that Acelarin may also have a potential immunomodulatory role. Acelarin was found to cause the release of Damage Associated Molecular Patterns, or DAMPs, and increase the expression of PD-L1 on cancer cells. The findings indicate that Acelarin produces changes in the cancer cells and the tumor microenvironment that could alter the recognition by the immune system, thus potentially making Acelarin an attractive combination partner for immune checkpoint inhibitors.

In the second AACR (Free AACR Whitepaper) abstract, an additional novel mode of action was identified for NUC-3373, NuCana’s ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), a very widely used anti-cancer drug. NUC-3373 was found to be a potent inhibitor of thymidylate synthase, which results in DNA damage of cancer cells. The recent in vitro studies have shown NUC-3373 is able to not only damage DNA, but also induce endoplasmic reticulum stress, and the subsequent release of DAMPs. Thus, in addition to being effective DNA damaging agents in cancer cells, these data suggest that both NUC-3373 and Acelarin may have the potential to alter tumor biology and enhance the activity of immune checkpoint inhibitors.

Hugh S. Griffith, NuCana’s Chief Executive Officer, said: "These findings reveal new and exciting modes of action of our ProTides and help to explain why they appear to be such potent anti-cancer agents."

Acelarin is currently being evaluated in a global Phase III study in combination with cisplatin as a first-line treatment for patients with advanced biliary tract cancer. NUC-3373 is in a Phase Ib clinical study in patients with advanced colorectal cancer in combination with other agents with which 5-FU is typically combined and a Phase I clinical study in patients with advanced solid tumors. NuCana’s third ProTide, NUC-7738, a transformation of a novel nucleoside analog, 3’-deoxyadenosine, is in a Phase I study in patients with advanced solid tumors.

Details of NuCana’s e-poster presentations on June 22-24, 2020: AACR (Free AACR Whitepaper) Virtual Annual Meeting II are as follows:

Abstract Title: NUC-1031 causes release of DAMPs and upregulates PD-L1 expression in lung cancer cells

Poster Number: 1840

Poster Session Title: Mechanisms of Drug Action 2

Abstract Title: NUC-3373 induces ER stress and the release of damage-associated molecular patterns in colorectal cancer cells

Poster Number: 1848

Poster Session Title: Mechanisms of Drug Action 2

Abstracts and full session details can be found at www.aacr.org

On May 15, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that preclinical data for TG-1701, the Company’s highly selective, BTK inhibitor, has been selected for presentation at the upcoming 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held virtually (Press release, TG Therapeutics, MAY 15, 2020, View Source [SID1234558114])

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The presentation details are as follows:

Title: TG-1701, a novel irreversible Bruton’s kinase (BTK) inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro, and cooperates with the glycoengineered anti-CD20 mAb, ublituximab, in in vivo mantle cell lymphoma models

Abstract Number: 2939
Available on Demand: Monday, June 22, 2020 at 9:00 AM ET
Session Title: Combination Immunotherapies 2
Presenting Author: Gaël Roué, PhD, Lymphoma Translational Group leader, Josep Carreras Leukaemia Research Institute (IJC)
A copy of the above referenced abstract can be viewed online through the AACR (Free AACR Whitepaper) meeting website at www.aacr.org. Following the presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com/publications.cfm.