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Verastem and The Leukemia & Lymphoma Society Partner to Accelerate Development of Duvelisib for the Treatment of Peripheral T-Cell Lymphoma

BOSTON, Mass.–(BUSINESS WIRE)–Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced a collaboration with The Leukemia & Lymphoma Society® (LLS), to accelerate the development of duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL), an aggressive type of non-Hodgkin lymphoma (NHL). Verastem Oncology’s duvelisib was selected for the LLS’s Therapy Acceleration Program® (TAP) which provides additional resources to support the development of therapies for patients with blood cancers. The Company plans to use the funds to conduct certain translational and clinical activities relating to the development of duvelisib for the treatment of PTCL. LLS and Verastem Oncology will share the cost of the development program, portions of which will be conducted in collaboration with Memorial Sloan Kettering Cancer Center, The Dana-Farber Cancer Institute, The Washington University in St. Louis and Stanford University.

“The selection of duvelisib for a TAP collaboration with the LLS underscores the potential of this innovative, oral monotherapy for patients with relapsed or refractory PTCL,” said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. “This collaboration provides important funding to accelerate the advancement of duvelisib as a potential new treatment for patients battling PTCL, either as a monotherapy or in combination with other anti-cancer agents. We look forward to collaborating with the LLS team on the exciting work ahead in order to advance duvelisib through the clinic and ultimately to the patients and families suffering from this devastating cancer.”

Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, that has demonstrated clinical activity in a Phase 1 clinical trial in 16 heavily pre-treated patients with relapsed or refractory PTCL (Horwitz, et al. Blood. Feb 2018). Results from the study showed duvelisib demonstrated a 50% overall response rate, including 19% complete responses.

Verastem Oncology is currently conducting an open-label, multicenter, Phase 2 clinical trial (the PRIMO study) evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL. This study is expected to enroll approximately 120 patients.

In addition, funds from the TAP will be used to support the expansion of an investigator-sponsored study being conducted by Steven Horwitz, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue. This study is evaluating the combination of duvelisib with romidepsin, an HDAC inhibitor, with a goal to create deeper and more durable responses for patients with relapsed or refractory PTCL. Initial data on the combination as presented at the American Society of Hematology (ASH) 2017 Annual Meeting, demonstrated a 64% overall response rate including 34% complete responses.

“The mission of our TAP program is to identify and fund the most promising investigational therapies that have the potential to change the standard of care for patients with blood cancers, with a particular focus on areas of the highest unmet medical need, such as relapsed or refractory PTCL,” Lee Greenberger, PhD, Chief Scientific Officer of LLS, commented. “Our partnership with Verastem Oncology is an excellent fit with our key initiative to accelerate development of new and cutting edge therapies like duvelisib, which specifically inhibits only certain PI3K family members, that have shown promising early clinical results in PTCL.”

* Duvelisib’s use in patients suffering from PTCL is solely investigational in nature; its use has not been deemed safe and effective by the U.S. Food and Drug Administration.

About the Therapy Acceleration Program®

The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (TAP) identifies and funds innovative projects related to therapies, supportive care or diagnostics that have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need. TAP funding assists both clinical investigators and companies in gaining critical clinical proof of concept data that better enables them to obtain the resources they need or a partner to complete the testing, registration and marketing of new treatments, supportive care and diagnostics for leukemia, lymphoma and myeloma. TAP funding is different from the traditional grant at LLS. The TAP review process is separate from the grant process and each approved project is closely monitored by TAP staff. To learn more about how TAP works, please click here.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called “T cells” and “natural killer (NK) cells”1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About Verastem Oncology

Verastem Oncology (Nasdaq: VSTM) is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. We are driven by the strength, tenacity and courage of those battling cancer – single-minded in our resolve to deliver new therapies that not only keep cancer at bay, but improve the lives of patients diagnosed with cancer. Because for us, it’s personal.

Our first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL). Our pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment. For more information, please visit www.verastem.com.

References

The Leukemia & Lymphoma Society. Peripheral T-Cell Lymphoma Facts. July 2014.
Leukemia Foundation. http://www.leukaemia.org.au/blood-cancers/lymphomas/non-hodgkin-lymphoma-nhl/peripheral-t-cell-lymphoma

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