LOS ANGELES - Puma Biotechnology, Inc. (NASDAQ: NASDAQ:PBYI) has commenced a Phase II clinical trial to evaluate the efficacy of its drug alisertib in treating extensive stage small cell lung cancer (SCLC), the company announced today. The trial, named ALISCA-Lung1, is designed to involve up to 60 patients who have seen their disease progress after initial platinum-based chemotherapy and immunotherapy.
The primary goal of the trial is to measure the objective response rate to alisertib, with secondary objectives including the duration of response, disease control rate, progression-free survival, and overall survival rates. Additionally, Puma Biotechnology will conduct a biomarker analysis to determine if certain patient subgroups experience enhanced efficacy from the treatment.
Patients enrolled in the trial will undergo a dosing regimen of 50 mg of alisertib twice daily on days 1 through 7 of each 21-day cycle. The company plans to perform an interim analysis to assess both the biomarkers and the drug's efficacy.
Puma's CEO, Alan H. Auerbach, expressed the company's hope that the study will provide valuable insights into alisertib's clinical activity in SCLC, especially in patients with tumors that may be more susceptible to an aurora kinase A inhibitor.
The biopharmaceutical company, which focuses on developing innovative cancer care products, has previously secured FDA approval for its drug neratinib for certain types of breast cancer. Puma acquired the rights to develop and commercialize alisertib, an aurora kinase A inhibitor, in September 2022, with an initial focus on SCLC and breast cancer.
The initiation of this trial could potentially lead to a meeting with the U.S. Food and Drug Administration to discuss an accelerated approval pathway for alisertib in SCLC, depending on the study's outcomes.
This news article is based on a press release statement from Puma Biotechnology, Inc.
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