Pharma Focus America

Puma Biotechnology Receives FDA Approval for IND Application of Alisertib in Small Cell Lung Cancer

Wednesday, August 09, 2023

Puma Biotechnology, a company specializing in biopharmaceuticals and traded on the NASDAQ as PBYI, has received communication from the U.S. Food and Drug Administration (FDA) regarding the approval of its Investigational New Drug (IND) application. This approval signifies Puma's clearance to proceed with the clinical advancement of alisertib as a standalone treatment. The target patient group for this therapy is those individuals diagnosed with extensive stage small cell lung cancer (SCLC).

The upcoming Phase II trial, named Study PUMA-ALI-4201, is slated to enroll a maximum of 60 participants. These individuals should have already experienced disease progression following initial treatments involving platinum-based chemotherapy and immunotherapy. As a prerequisite for participation, patients will be required to furnish tissue-based biopsy samples to enable subsequent biomarker analysis. The administration of alisertib will involve a 50 mg BID dosage on days 1-7, within a 21-day cycle. The anticipated timeline for commencing the Phase II trial is set for the latter half of 2023.

This clearance allows Puma to proceed with clinical development of alisertib, focusing on its potential as a monotherapy for extensive stage small cell lung cancer (SCLC).

The upcoming Phase II trial, named Study PUMA-ALI-4201, is slated to involve up to 60 patients who have experienced disease progression after initial treatment with platinum-based chemotherapy and immunotherapy. As part of the trial criteria, patients are required to provide tissue-based biopsy samples to enable biomarker analysis. Alisertib will be administered at a dosage of 50 mg BID on days 1-7 within a 21-day cycle. The Phase II trial is anticipated to commence in the latter half of 2023.

The trial's primary endpoint is the objective response rate, with secondary endpoints encompassing factors like duration of response, disease control rate, progression-free survival, and overall survival. Puma also plans to explore these endpoints within predefined biomarker subgroups to determine if enhanced efficacy is observed in any specific subgroup. The biomarker analysis will be conducted in parallel with the clinical trial, incorporating an initial interim analysis to evaluate both biomarkers and efficacy.

Dr. Taofeek K. Owonikoko, Chief of the Division of Hematology/Oncology and Associate Director for Translational Research at the UPMC Hillman Cancer Center, highlighted the urgency for new treatment options for patients with advanced small cell lung cancer. He emphasized the potential of alisertib, particularly in patients whose tumors carry molecular markers associated with the clinical activity of aurora kinase A inhibitors like alisertib.

Alan H. Auerbach, CEO, President, and Founder of Puma Biotechnology, expressed enthusiasm about progressing to the clinical development phase for alisertib in small cell lung cancer. He looks forward to gaining valuable insights from the Phase II trial, especially regarding the drug's effectiveness in patients with molecularly defined tumors that could respond well to an aurora kinase A inhibitor like alisertib.

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