BOSTON, MA, December 5, 2020 - Verastem, Inc. (Nasdaq:VSTM), a biopharmaceutical company today presented the expansion phase initial results for COPIKTRA® (duvelisib) in patients with relapsed/refractory peripheral T-Cell lymphoma (PTCL) from the Phase 2 PRIMO trial at the American Society of Hematology 2020 Annual Meeting via an oral presentation. Secura Bio recently acquired the rights to duvelisib and aims to continue development in PTCL.
The PRIMO study is a multi-center, open-label, registration-directed Phase 2 study evaluating duvelisib in patients with relapsed or refractory PTCL that is expected to enroll approximately 120 patients. In the dose optimization portion of the study, patients were randomized to receive duvelisib 25mg twice daily with an option for dose escalation (cohort 1) or duvelisib 75mg twice daily continuously (cohort 2) until disease progression or unacceptable toxicity. The primary endpoint of the study was investigator-assessed overall response rate (ORR), and secondary endpoints included duration of response (DOR) and safety.
Presented at ASH, the mature results of the dose-optimization phase (N=33) showed a 62% ORR in the 75 mg BID (N=13) and 40% in the 25 mg BID (N=20) cohorts. The mature dose-optimization phase results demonstrated a median DOR of 12.2 months for the 75 mg BID cohort. The preliminary results from the PRIMO dose-expansion cohort (75 mg BID followed by 25 mg BID dosing) show an ORR of 52% and CR rate of 36% (9/25). The safety profile observed in PRIMO to date is consistent with the current safety profile of duvelisib from other studies. These data support continued evaluation of duvelisib as a treatment option for R/R PTCL.
It is anticipated that the current trial will conclude enrollment in February 2021.