On November 1, 2017 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported that four abstracts have been selected for presentation, including two oral presentations, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting being held December 9-12, 2017 in Atlanta (Press release, Verastem, NOV 1, 2017, View Source [SID1234521407]). Included among the oral presentations are the detailed results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). As previously announced, the DUO study achieved its primary endpoint with oral duvelisib monotherapy demonstrating superiority over ofatumumab for progression free survival (PFS) in patients with CLL/SLL.
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“Previously reported top-line data from the pivotal Phase 3 DUO study significantly favored duvelisib monotherapy over ofatumumab, an approved standard of care treatment for patients with relapsed or refractory CLL/SLL, achieving a statistically significant improvement in median PFS and a hazard ratio (HR) of 0.52 (p<0.0001), with a consistent and manageable safety profile," said Robert Forrester, President and Chief Executive Officer of Verastem. "We look forward to sharing the detailed results from the DUO study with the medical community at ASH (Free ASH Whitepaper) this year."
Verastem recently announced that a meeting was held with the U.S. Food and Drug Administration (FDA) regarding the regulatory path for duvelisib. Based on the meeting with, and written feedback from the FDA, Verastem intends to submit a 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). Along with the clinical data from the DUO study, the duvelisib NDA submission will also contain the favorable results from the Phase 2 DYNAMO study in double-refractory indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46% (p<0.0001). In the subset of patients enrolled in the DYNAMO study with double-refractory FL (n=83), duvelisib demonstrated an ORR of 41%. The Company expects to submit the duvelisib NDA during the first quarter of 2018.
Details for the ASH (Free ASH Whitepaper) 2017 presentations are as follows:
Oral Presentations
Title: Results from the Phase 3 DUOTM Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Presenter: Ian Flinn, M.D., Ph.D., Sarah Cannon Research Institute
Abstract Number/Publication ID: 493
Session: 642. CLL: Therapy, excluding Transplantation: Targeting MRD Negative CLL with Combinations of Novel Agents and Chemoimmunotherapy Regimens, New Treatments; Sunday, December 10, 2017 from 4:30-6:00 PM ET
Date and Time: Sunday, December 10, 2017 at 4:30 PM ET
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4
Title: In Vitro, In Vivo, and Parallel Phase I Evidence Support the Safety and Activity of Duvelisib, a PI3K-δ,γ Inhibitor, in Combination with Romidepsin or Bortezomib in Relapsed/Refractory T-Cell Lymphoma
Presenter: Steven Horwitz, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number/Publication ID: 819
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: T-Cell Lymphoma Clinical Studies; Monday, December 11, 2017 from 4:30-6:00 PM ET
Date and Time: Monday, December 11, 2017 at 5:00 PM ET
Location: Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Poster Presentations
Title: The Dual PI3K-δ,γ Inhibitor Duvelisib Stimulates Anti-Tumor Immunity and Enhances Efficacy of Immune Checkpoint and Co-Stimulatory Antibodies in a B Cell Lymphoma Model
Presenter: Jonathan Pachter, Ph.D., Verastem
Abstract Number/Publication ID: 1541
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I
Date and Time: Saturday, December 9, 2017 from 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Combinatorial Inhibition of Focal Adhesion Kinase and BCL-2 in AML
Presenter: Xiangmeng Wang, Ph.D., MD Anderson Cancer Center
Abstract Number/Publication ID: 2653
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
About Duvelisib
Duvelisib is a first-in-class investigational, 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-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being 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 (CLL)/small lymphocytic lymphoma (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 and Verastem intends to submit a 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). Duvelisib is also being developed by Verastem 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.