On May 17, 2018 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the selection of four abstracts for oral and poster presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 14-17, 2018 in Stockholm, Sweden (Press release, Verastem, MAY 17, 2018, View Source [SID1234526786]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. An oral presentation by Dr. Matthew Davids, Dana-Farber Cancer Institute, will highlight the latest data from a Phase Ib/II study of duvelisib in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL). Three posters will highlight additional duvelisib data, including crossover extension results from the Phase 3 DUO study in patients with relapsed or refractory CLL/small lymphocytic lymphoma (CLL/SLL), and new biomarker analyses on the tumor microenvironment modulation from DUOTM and the Phase 2 DYNAMOTM study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and the dual PI3K-delta and PI3K-gamma activity of duvelisib in the CONTEMPOTM study in patients with untreated follicular lymphoma who are treated with duvelisib in combination with CD20 antibody immunotherapy.

"At EHA (Free EHA Whitepaper) 2018, Dr. Matthew Davids will deliver an oral presentation describing results from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger CLL patients," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. "To date, the combination regimen has shown to be effective as an initial therapy with an ORR of 97%, including 28% of evaluable patients achieving a complete response or complete response with incomplete blood count recovery, and 69% achieving a partial response. A high rate of 81% bone marrow MRD negativity was observed in patients with at least one evaluation. Collectively, the data being presented at EHA (Free EHA Whitepaper) this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents."

Details for the EHA (Free EHA Whitepaper) 2018 presentation and posters are as follows:

Oral Presentation

Title: A Phase IB/II Study of duvelisib in combination with FCR (DFCR) for Frontline Therapy of Younger CLL Patients
Lead author: Dr. Matthew Davids, Dana-Farber Cancer Institute
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Combination treatment with targeted agents in CLL
Date and Time: Saturday, June 16, 12:15 – 12:30 CEST
Location: Victoria Hall
Final Abstract Code: S807
Poster Presentations

Title:The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension Study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF354

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma.
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF646

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study).
Lead author: Dr. David Weaver, Verastem Oncology
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF649

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov