the summer , NevadaApril 10, 2021 / PRNewswire / – Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to developing and marketing effective oncological therapies, today announced that it enrolled 101 patients in the PRIMO study to evaluate COPIKTRA for the treatment of patients with relapsing or refractory T-cell lymphoma peripheral T-cell lymphoma ( PTCL). Completion of registration is an important milestone in the further development of COPIKTRA for the treatment of T lymphoma, a disease category not currently referenced.
The PRIMO study is a global, multicenter, open phase 2 study with parallel cohort scoring. In the dose improvement portion of the study, patients were randomized to receive 25 mg COPIKTRA twice daily (group 1) or 75 mg COPIKTRA twice daily (group 2), either until disease progression or until toxicity became unacceptable. Based on the dose optimization results, an expansion group was added in which COPIKTRA was dosed twice daily for two cycles of 75 mg followed by 25 mg twice daily until disease progression or unacceptable toxicity. The primary endpoint in the study expansion phase is the assessment of the objective overall response rate (ORR) by the Independent Review Board, and the secondary endpoints are the response duration (DOR) and safety.
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