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Puma Biotechnology Announces Presentation of Findings from a Phase I/II Study of Alisertib and Pembrolizumab for Rb-Deficient Head and Neck Squamous Cell Carcinomas at the 2023 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the poster presentation of a Phase I/II trial
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[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the poster presentation of a Phase I/II trial of alisertib plus pembrolizumab for the treatment of patients with Rb-deficient head and neck squamous cell carcinoma (Clinicaltrials.gov identifier NCT04555837) at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts. The poster (number LB_C12), entitled “Alisertib and pembrolizumab in Rb-deficient head and neck squamous cell carcinomas (HNSCC),” was presented by Faye M. Johnson, M.D., Ph.D., Department of Thoracic/Head & Neck Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, in the Late-breaking Poster Session C on Saturday, October 14 at 12:30 pm ET. A copy of the poster is available on the Puma website.\n\n\nAlisertib is an adenosine triphosphate–competitive, reversible inhibitor of Aurora Kinase A (AURKA) that results in disruption of mitosis. Human papillomavirus (HPV) is a common cause of HNSCC, and infection leads to Retinoblastoma protein (Rb1) degradation. A synthetic lethal relationship between AURKA and Rb1 has been implicated preclinically, and alisertib has been shown to induce immunogenic cell death in HPV+ cancer cells.\n\n\nThe investigator-sponsored clinical trial was conducted sequentially in two parts: A Phase I study to determine the recommended dose for alisertib in combination with pembroluzimab in patients with advanced solid tumors, and a Phase II study to evaluate efficacy of alisertib and pembroluzimab in patients with recurrent or metastatic, Rb-deficient HNSCC who had progressed on prior anti-PD1 therapy. Biomarkers of response were also evaluated.\n\n\nThe Phase I portion of the study enrolled ten patients with advanced solid tumors. There was no requirement for Rb deficiency in the Phase I portion of the trial. Alisertib was dosed twice daily for seven days every twenty-one days at either 30 mg, 40 mg, or 50 mg, and pembrolizumab was dosed at 200 mg intravenously every three weeks. The observed dose-limiting toxicities were predominantly hematologic in nature and congruent with the expected safety profile. Based on these findings, the 40 mg dose level was selected for the Phase II portion of the study. The Phase I portion of the trial...