On September 17, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the initiation of its ALISertib in CAncer (ALISCA-Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The ALISCA-Lung2 trial is a sequential dose escalation study that will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The primary endpoint of the trial is the 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 will also evaluate clinical biomarkers to help identify which patients have the greatest benefit to guide the future development of alisertib.

Taofeek K. Owonikoko, MD, PhD and Chair of the trial’s Steering Committee, said, "Treatment options for patients with small cell lung cancer that has progressed following platinum-based chemotherapy and immunotherapy remain limited, and there is an urgent need for new treatment approaches for these patients. I am pleased to see further evaluation of alisertib in these patients." Dr. Owonikoko is the Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, and the Kevin J. Cullen, MD Distinguished Professor of Oncology at the University of Maryland School of Medicine. He added, "The results from previous clinical trials of alisertib in small cell lung cancer, including those in combination with paclitaxel, suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib."

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, "We are pleased to initiate this Phase II trial, and we hope that the study will provide important insight into the safety and clinical activity of alisertib in combination with paclitaxel in patients with small cell lung cancer. We are continuing to advance alisertib monotherapy in the ALISCA-Lung1 trial as well, and we view the ALISCA-Lung2 trial as additive to the clinical development of alisertib in small cell lung cancer. We look forward to the progress of both the ALISCA-Lung1 and ALISCA-Lung2 trials, as well as our other ongoing clinical programs, in the months ahead."

(Press release, Puma Biotechnology, SEP 17, 2026, View Source [SID1234670934])