Puma inititates ALISCA-Lung1 Phase II trial of Alisertib in SCLC

Puma Biotechnology announced the initiation of its ALISertib in CAncer or ALISCA-Lung1, Phase II trial or PUMA-ALI-4201; NCT06095505, of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. The ALISCA-Lung1 trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed on or after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue specimens so that biomarkers can be analyzed. Alisertib is dosed at 50 mg BID on days 1-7 of every 21-day cycle. The primary endpoint of the trial is objective response rate, with secondary endpoints of duration of response, disease control rate, progression-free survival and overall survival. Puma will also be looking at each of these endpoints within selected pre-specified biomarker subgroups and will assess whether there is enhanced efficacy in any biomarker subgroup. Puma will be performing its biomarker analysis of the ALISCA-Lung1 trial in parallel with the execution of the clinical trial. Puma plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. Based upon the outcomes of the study, Puma anticipates meeting with the U.S. Food and Drug Administration to explore the potential for an accelerated approval pathway for alisertib in small cell lung cancer. ”