Puma Biotech Announces FDA Clearance of IND for Alisertib in Small Cell Lung Cancer

Published 08-08-2023, 06:04 pm
PBYI
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Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, 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.

“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, Chief of the Division of Hematology/Oncology and Associate Director for Translational Research and Co-Leader of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center. “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 move forward with the clinical development of alisertib in small cell lung cancer. We are eagerly awaiting the start of 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.”

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