Puma Biotechnology, Inc. (NASDAQ: PBYI) has initiated a Phase II clinical trial, ALISCA-Lung2, evaluating alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer, according to a company press release.

The trial, designated PUMA-ALI-4202 (NCT07465757), is a sequential dose escalation study expected to enroll approximately 50 patients whose disease has progressed following platinum-based chemotherapy and immunotherapy. The primary endpoint is safety and tolerability of alisertib when administered with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival.

Puma also plans to evaluate clinical biomarkers to identify patient subsets most likely to benefit from treatment.

Taofeek K. Owonikoko, MD, PhD, chair of the trial's Steering Committee and Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, noted that treatment options for patients whose small cell lung cancer has progressed after standard therapies "remain limited." He added that results from previous trials of alisertib, including combinations with paclitaxel, "suggest that the drug may represent a potentially promising treatment option" for certain patient subsets whose tumors carry molecular markers associated with aurora kinase A inhibitor activity.

Alisertib is a selective, orally administered inhibitor of aurora kinase A. Puma licensed the drug in September 2022 and has been developing it across multiple indications. The company initiated the ALISCA-Lung1 monotherapy trial in February 2024 and the ALISCA-Breast1 trial in November 2024, the latter evaluating alisertib in combination with endocrine therapy for HER2-negative, hormone receptor-positive metastatic breast cancer.

Puma's chief executive, Alan H. Auerbach, stated the company views the ALISCA-Lung2 trial as complementary to its ongoing ALISCA-Lung1 program.