Puma Biotechnology Inc

Puma Biotechnology, Inc. announced the initiation of its ALISCA-Lung2 Phase II trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The sequential dose escalation study, designated PUMA-ALI-4202 and registered as NCT07465757, will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy. The primary endpoint is the safety and tolerability of alisertib when administered with paclitaxel, while secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival, and Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit. Taofeek K. Owonikoko, Chair of the trial's Steering Committee, said treatment options for patients whose small cell lung cancer has progressed following platinum-based chemotherapy and immunotherapy remain limited and that prior trial results suggest alisertib may be a promising option, particularly for patient subsets whose tumors harbor potential molecular markers associated with the clinical activity of an aurora kinase A inhibitor. Puma CEO, President and Founder Alan H. Auerbach said the company views ALISCA-Lung2 as additive to the clinical development of alisertib in small cell lung cancer, where it is continuing to advance alisertib monotherapy in the ALISCA-Lung1 trial.