Puma Launches Phase II ALISCA-Lung1 Trial for SCLC Treatment

Puma Biotechnology, a biopharmaceutical firm, has recently launched a Phase II clinical trial for alisertib, a drug used to treat extensive stage small cell lung cancer (SCLC). The ALISCA-Lung1 study, designated PUMA-ALI-4201 and registered under NCT06095505, aims to enroll approximately 60 patients who have seen disease progression following initial platinum-based chemotherapy and immunotherapy treatments. The trial requires participants to submit tissue samples for biomarker analysis, with alisertib administered at a dosage of 50 mg twice daily for the first week of each 21-day cycle.

The primary goal of the study is to measure the objective response rate, with secondary goals that include the duration of response, disease control rate, progression-free survival, and overall survival. Puma Biotechnology is particularly interested in examining these endpoints within specific biomarker subgroups to determine if there is any enhanced drug efficacy. The company plans to conduct an interim analysis to evaluate both biomarkers and efficacy, with the intention of discussing potential accelerated approval for alisertib in treating SCLC with the U.S. Food and Drug Administration based on the study's outcomes.

Dr. Taofeek K. Owonikoko, a professor of oncology, highlighted the scarcity of effective treatments for SCLC patients who have not responded to platinum-based chemotherapy, emphasizing the urgency for new therapeutic options. He noted that alisertib's previous clinical trial results suggest it could be a promising treatment, especially for patients with tumors that have molecular markers associated with the activity of aurora kinase A inhibitors.

Alan H. Auerbach, CEO, President, and Founder of Puma Biotechnology, expressed enthusiasm for initiating the Phase II trial, hoping it will shed light on alisertib's clinical activity in treating SCLC, particularly in patients with molecularly defined tumors that could be targeted by aurora kinase A inhibitors.

Puma Biotechnology specializes in developing and commercializing innovative cancer care products. The company holds the global rights to develop and market PB272 (neratinib, oral and intravenous) and PB357. Neratinib, available orally, was approved by the FDA in 2017 for treating early-stage HER2-overexpressed/amplified breast cancer and, in 2020, for advanced or metastatic HER2-positive breast cancer in combination with capecitabine. It has also received marketing authorization in Europe for similar indications. NERLYNX, the brand name for neratinib, is a registered trademark of Puma Biotechnology.

In September 2022, Puma secured an exclusive license for the development and commercialization of alisertib, focusing on its application in treating SCLC and breast cancer.