On December 3, 2018 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, reported an oral presentation highlighting new clinical data from an investigator sponsored trial, led by Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center (MSK), evaluating duvelisib in combination with romidepsin in patients with relapsed or refractory T-cell lymphomas, including peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, taking place December 1-4, 2018, in San Diego (Press release, Verastem, DEC 3, 2018, View Source [SID1234531847]). Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

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"The data demonstrate that the combination of oral duvelisib and romidepsin has an acceptable safety profile and the presence of early signals of anti-lymphoma activity in patients with PTCL," said Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center (MSK), co-principal investigator of the Phase 1 study, and lead author of the oral presentation. "The response rate observed to date from the combination is compelling considering that PTCL is an aggressive type of non-Hodgkin lymphoma for which new therapies are desperately needed. We look forward to further elucidating the potential of this novel combination regimen through completion of this expansion cohort."

Phase 1 Results with Duvelisib and Romidepsin in Relapsed or Refractory PTCL

In this multicenter, dose-expansion portion of the Phase 1 trial, oral duvelisib was dosed at 75mg twice-daily (BID) on days 1-28. Romidepsin 10mg/m2 was dosed on Days 1, 8, and 15 on a 28-day cycle. Of the 38 patients evaluable for efficacy (PTCL, n=27; CTCL, n=11), 21 responded (9 complete responses (CRs) and 12 partial responses (PRs)) for an overall response rate (ORR) of 55%. Sixteen of the 27 patients with PTCL responded (9 CRs and 7 PRs) for an ORR of 59%. Five of the 11 patients with CTCL responded (all PRs) for an ORR of 45%. Median progression-free survival (PFS) for patients with PTCL was 6.72 months and 5.41 months for patients with CTCL. Among the 39 patients evaluable for safety, the most common Grade ≥3 adverse events were neutropenia (33%), diarrhea (15%) and increased alanine aminotransferase (13%).

A PDF copy of the oral presentation will be available here following the conclusion of the session.

Verastem Oncology is currently conducting an open-label, multicenter, Phase 2 clinical trial (the PRIMO study; NCT03372057) 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, Verastem Oncology’s PTCL program was recently selected to participate in The Leukemia and Lymphoma Society’s Therapy Acceleration Program which provides additional resources to support the development of therapies for patients with blood cancers. The program is supporting work on translational biomarkers of response, patient enrollment acceleration in PRIMO and an increase in the total patient enrollment in the combination study of duvelisib and romidepsin being presented at ASH (Free ASH Whitepaper).

Details for presentation are as follows:

Oral Presentation

Title: The combination of Duvelisib, a PI3K-δ,γ Inhibitor, and Romidepsin is highly active in relapsed/refractory peripheral T-cell lymphoma with low rates of transaminitis: Results of a multicenter, multi-arm phase 1 study with expansion cohorts
Presenter: Steven Horwitz, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue
Abstract Number/Publication ID: 683
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Immunotherapy and Targeted Strategies

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