Puma Biotechnology, Inc. has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has been reviewed, and Puma can proceed with the clinical development of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (SCLC). Puma?s Phase II trial (Study PUMA-ALI-4201) will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue-based biopsies so that biomarkers can be analyzed.

Alisertib will be dosed at 50 mg BID on days 1-7 of every 21 day cycle. The Company anticipates initiating the Phase II trial in the second half of 2023. The primary endpoint of the trial will be objective response rate with secondary endpoints of duration of response, disease control rate, progression free survival and overall survival.

The Company will also be looking at each of these endpoints within selected pre-specified biomarker subgroups as well as to assess whether there is enhanced efficacy in any biomarker subgroup. Puma will be performing its biomarker analysis of the ALI-4201 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 the efficacy.

Based upon the outcomes of the study, the Company anticipates meeting with the FDA to explore the potential for an accelerated approval pathway for alisertib in small cell lung cancer.