Verastem announces 62% response rate for duvelisib in T-cell lymphoma
Verastem announced the presentation of abstracts highlighting Copiktra data at the American Society of Hematology 2019 Annual Meeting. "Given the aggressive nature of peripheral T-cell lymphoma and the lack of effective therapeutic options for these patients, we are pleased to present data from the dose optimization phase of our PRIMO trial that demonstrated a 62% overall response rate, as assessed by independent central review, with a manageable safety profile consistent with previous clinical trials. The results of the trial also identified the optimal dosing regimen for future clinical study," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The expansion phase of this registration-directed study is well underway. Upon completion, we plan to build upon our existing Fast Track Designation and Orphan Drug Designation and submit a regulatory package to the U.S. FDA with the goal of broadening the use of COPIKTRA to include treatment of PTCL." A total of 33 patients were treated in the dose optimization phase. Investigator-assessed ORRs were 35% in cohort 1 and 54% in cohort 2, with complete response rates of 25% and 31% in cohort 1 and cohort 2, respectively, the company said. Thirteen of 20 patients in cohort 1 and all patients in cohort 2 were able to complete one cycle of therapy. Seven patients in cohort 1 discontinued therapy early due to disease progression and/or toxicity. Another presentation at the meeting highlights new data from an investigator-sponsored Phase 1 study exploring duvelisib in combination with venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Duvelisib plus venetoclax demonstrated promising clinical activity, a manageable tolerability profile, and a recommended Phase 2 dose of 400mg of venetoclax was determined for this regimen, according to Verastem.