BOSTON--(BUSINESS WIRE)-- Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced that five posters highlighting clinical data for COPIKTRA™ (duvelisib) will be presented at the Lymphoma & Myeloma 2019 International Congress taking place October 23-26, 2019, in New York City. The presented abstracts focus on clinical data from the Phase 3 DUO study, including evaluation of COPIKTRA efficacy and safety in high-risk patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), dose modification data and results from a post-hoc analysis evaluating the effect of COPIKTRA on lymphocytosis in patients. Other presented data include the characterization of duvelisib in patients with refractory Marginal Zone Lymphoma from the Phase 2 DYNAMO study, and an update on the safety profile and management of adverse events in heavily pre-treated patients with advanced hematological malignancies.
“Findings from the DUO study demonstrated that patients taking duvelisib who have received two or more prior therapies experienced improved clinical outcomes and a manageable safety profile,” states Matthew S. Davids, MD, Associate Director, Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute. “These results with duvelisib are important for this patient population, which is in need of targeted therapies to control their disease.”
“The data presented at this year’s Lymphoma & Myeloma Congress reflect the utility of duvelisib in patients with relapsed or refractory CLL/SLL after at least two prior therapies, including in patients with advanced disease or at high-risk of recurrence,” commented Hagop Youssoufian, MSc, M.D., Head of Medical Strategy at Verastem Oncology. “Further, the research supports the approach to management of adverse events through dose interruptions or dose reductions without an impact on the patient’s response, which could allow patients who are benefitting to stay on therapy longer.”
COPIKTRA, a targeted oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval as monotherapy from the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of patients with relapsed or refractory CLL/SLL after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Continued approval in FL may be contingent upon verification and description of clinical benefit in confirmatory trials.
Details for the poster presentations are as follows:
Title: An improved benefit-risk profile of duvelisib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who received ≥2 prior therapies Lead author: Matt Davids, M.D., Dana-Farber Cancer Institute, Boston, MA Presentation ID: P-012
Title: Effect of dose modifications on response to duvelisib in patients with relapsed or refractory CLL/SLL in the DUO trial Lead author: Nicole Lamanna, Columbia University Medical Center Presentation ID: P-030
Title: Patterns of duvelisib-induced lymphocytosis in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including those with high-risk factors treated in the DUO trial Lead author: Jacqueline Barrientos, Zucker School of Medicine at Hofstra/Northwell Presentation ID: P-015
Title: Characterization of duvelisib in patients with refractory marginal zone lymphoma: data from the phase 2 DYNAMO trial Lead author: Eric Jacobsen, Dana-Farber Cancer Institute, Boston, MA Presentation ID: P-029
Title: Safety Profile and Management of Adverse Events Associated with Duvelisib in Patients with Advanced Hematologic Malignancies Lead author: Karen Francoeur, Verastem Oncology Presentation ID: P-031
PDF copies of these poster presentations will be available here after the meeting.
COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA™ (duvelisib) safely and effectively. See full Prescribing Information.
| WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS |
| See full Prescribing Information for complete boxed warning |
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