We are currently developing duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K-delta and PI3K-gamma), which has successfully met its primary endpoint in a Phase 3 registration trial in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and a Phase 2 study in refractory indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL).
We have a COM (composition-of-matter) patent protection of duvelisib through 2030 before extensions, and has received orphan drug designation for duvelisib in follicular lymphoma (FL), CLL and small lymphocytic lymphoma (SLL) in the United States and the European Union. The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with CLL who have received at least one prior therapy, of patients with FL who have received at least two prior therapies and of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy.
In April 2018, the FDA accepted with Priority Review our New Drug Application (NDA) for duvelisib.
Analyst & Investor Day 2018
In May 2018, Verastem Oncology hosted an Analyst & Investor Day – “Duvelisib: Harnessing the Power of Dual PI3K Inhibition.” Leading experts in hematologic malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), and peripheral T-cell lymphoma (PTCL), provided an in-depth discussion regarding the current U.S. treatment landscape, where phosphoinositide-3-kinase (PI3K)- inhibitors fit into the treatment paradigm and the need for new anti-cancer agents, including duvelisib. Below are highlights from the program.
Brian Koffman, MDCM, DCFP, FCFP, DABFP, MSEd, Physician, Founder & President of the CLL Society, and CLL patient discussed the CLL patient journey, along with the learnings and challenges of living with high-risk disease.
Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School, gave a compelling presentation on the role of PI3K inhibitors as treatment evolves towards a chemo-free future for many patients with B-cell malignancies.
Ian Flinn, MD, PhD, Director, Blood Cancer Research Program at Sarah Cannon Research Institute presented data from the DUO™ and DYNAMO™ studies, the basis for the New Drug Application for duvelisib.
Dr. Steve Horwitz, Medical Oncologist at Memorial Sloan Kettering, presented an overview of the unmet need for new strategies in T-cell lymphoma.
Robert Forrester, President and Chief Executive Officer of Verastem Oncology, reiterated the company’s commitment to developing therapies with the potential to make meaningful differences in the lives of patients battling cancer.
Other clinical product candidates include focal adhesion kinase (FAK) inhibitor defactinib. Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic, ovarian and non-small cell lung cancer (NSCLC), and mesothelioma.