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Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

  • Puma Biotechnology initiated the ALISCA-Lung2 Phase II trial (PUMA-ALI-4202; NCT07465757) in September 2026 to evaluate alisertib combined with paclitaxel for advanced small cell lung cancer.
  • The sequential dose escalation study will enroll approximately 50 patients who have progressed on or after treatment with platinum-based chemotherapy & immunotherapy.
  • The primary endpoint is the safety & tolerability of alisertib when administered with paclitaxel, while secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, & overall survival.
  • Researchers will evaluate clinical biomarkers to identify patient subsets likely to benefit from the aurora kinase A inhibitor alisertib.
  • Dr. Taofeek K. Owonikoko, Chair of the trial's Steering Committee, noted the urgent need for new treatment approaches for patients with limited options & highlighted promising results from previous trials.
  • CEO Alan H. Auerbach stated the trial provides important insights into alisertib's safety & clinical activity & serves as an additive effort to the ongoing ALISCA-Lung1 monotherapy trial.
  • Puma acquired global development & commercialization rights to alisertib in September 2022, with initial development focused on small cell lung cancer & breast cancer.
  • Puma previously initiated the ALISCA-Lung1 trial in February 2024 for alisertib monotherapy & the ALISCA-Breast1 trial in November 2024 for alisertib combined with endocrine therapy.
  • The company markets NERLYNX (neratinib) for HER2-positive breast cancer, having received FDA approvals in 2017 & 2020 & European Commission authorization in 2018.
  • This press release includes forward-looking statements regarding alisertib development & clinical trials, noting risks that could cause actual results to differ materially from expectations.