Alisertib - (PUMA-ALI-4201) in combination with paclitaxel - (ALISCA-Lung2)

September 17, 2026: Puma Biotechnology (NASDAQ: PBYI) announced initiation of ALISCA-Lung2 (PUMA-ALI-4202; NCT07465757), a Phase II sequential dose-escalation trial of alisertib plus paclitaxel in advanced small cell lung cancer. The study is expected to enroll about 50 patients whose disease progressed on or after platinum-based chemotherapy and immunotherapy.

The primary endpoint is safety and tolerability of alisertib with paclitaxel. Secondary endpoints are objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. The trial will also assess clinical biomarkers to identify patients most likely to benefit.

The release also notes Puma is continuing ALISCA-Lung1, a Phase II trial of alisertib monotherapy in extensive-stage small cell lung cancer, which was initiated in February 2024, and ALISCA-Breast1, a Phase II trial of alisertib plus endocrine therapy in HER2-negative, HR-positive metastatic breast cancer, initiated in November 2024. The company said ALISCA-Lung2 is additive to the clinical development of alisertib in small cell lung cancer.