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LOS ANGELES – Puma Biotechnology, Inc. (NASDAQ: NASDAQ 🙂 has begun a Phase II clinical trial to evaluate the effectiveness of its drug alisertib in the treatment of extensive-stage small cell lung cancer (SCLC), the company announced today. company. The trial, called ALISCA-Lung1, is designed to enroll up to 60 patients who have seen their disease progress after initial platinum-based chemotherapy and immunotherapy.
The primary objective of the trial is to measure the objective response rate to alisertib, with secondary objectives including duration of response, disease control rate, progression-free survival, and overall survival rates. Additionally, Puma Biotechnology will conduct biomarker analysis to determine whether certain subgroups of patients experience greater treatment efficacy.
Patients enrolled in the trial will undergo a dosing regimen of 50 mg alisertib twice daily on days 1 through 7 of each 21-day cycle. The company plans to conduct an interim analysis to evaluate both the biomarkers and the efficacy of the drug.
Puma CEO Alan H. Auerbach expressed the company's hope that the study will provide valuable information about the clinical activity of alisertib in SCLC, especially in patients with tumors that may be more susceptible to an aurora kinase inhibitor. TO.
The biopharmaceutical company, which focuses on developing innovative products for the treatment of cancer, previously obtained 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 US Food and Drug Administration to discuss an accelerated approval pathway for alisertib in SCLC, depending on the results of the study.
This news article is based on a press release from Puma Biotechnology, Inc.
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