On February 13, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the initiation of its ALISertib in CAncer (ALISCA-Lung1) Phase II trial (PUMA-ALI-4201; NCT06095505) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Press release, Puma Biotechnology, FEB 13, 2024, View Source [SID1234640056]). 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.
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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.
"Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population," said Taofeek K. Owonikoko, MD, PhD, Marlene and Stewart Greenbaum Professor of Oncology in the Department of Medicine at the University of Maryland, Baltimore. "The results from the previous clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib," said Dr. Owonikoko.
Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, "We are pleased to initiate this Phase II trial, and we hope that the study will provide much needed insight into the clinical activity of alisertib in small cell lung cancer and, more specifically, in patients with molecularly defined tumors that may be targetable with an aurora kinase A inhibitor like alisertib."