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

Puma Biotechnology, a leading biopharmaceutical company, recently presented the results of a Phase I/II trial at the prestigious AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The trial focused on the use of alisertib, in combination with pembrolizumab, for the treatment of patients with Rb-deficient head and neck squamous cell carcinoma (HNSCC).

The study, conducted by the University of Texas MD Anderson Cancer Center, aimed to evaluate the efficacy of alisertib and pembrolizumab in patients with recurrent or metastatic, Rb-deficient HNSCC who had previously progressed on anti-PD1 therapy. The trial also explored biomarkers of response.

Alisertib, an inhibitor of Aurora Kinase A (AURKA), disrupts mitosis and has shown promise in inducing immunogenic cell death in HPV-positive cancer cells. Human papillomavirus (HPV) is a common cause of HNSCC, and the degradation of the Retinoblastoma protein (Rb1) is associated with infection.

The Phase I portion of the trial enrolled ten patients with advanced solid tumors, while the Phase II portion included fourteen patients with immunotherapy- and platinum-resistant HPV-positive HNSCC. Although no objective responses were observed, seven patients experienced stable disease, with three achieving progression-free survival exceeding 8 months. The median overall survival was 13.5 months, and no new safety signals were observed.

The study also examined the relationship between biomarkers and response. Patients with longer progression-free survival exhibited lower baseline plasma cytokine levels and an increase in certain immune cells. Additionally, an increase in quantitative levels of HPV cell-free DNA corresponded with disease progression.

Dr. Faye M. Johnson, who presented the findings, emphasized the need for better treatment options for HNSCC, particularly in cases of immune checkpoint therapy resistance. She expressed optimism about the combination of alisertib and pembrolizumab, noting that it was well-tolerated and led to prolonged stable disease in patients who had previously progressed on immunotherapy.

Alan H. Auerbach, CEO and President of Puma Biotechnology, expressed intrigue and commitment to the development of alisertib. He highlighted the potential of biomarker-defined populations that may benefit most from this treatment.

Puma Biotechnology is a biopharmaceutical company dedicated to enhancing cancer care through the development and commercialization of innovative products. The company has successfully obtained FDA approval for its oral neratinib, marketed as NERLYNX®, for the treatment of early-stage HER2-positive breast cancer. In addition, Puma recently entered into an exclusive license agreement for the development and commercialization of alisertib, focusing initially on small cell lung cancer and breast cancer.

The results of the Phase I/II trial presented by Puma Biotechnology offer hope for patients with Rb-deficient HNSCC. The company’s commitment to advancing cancer care and exploring novel treatment options underscores its dedication to improving patient outcomes. With ongoing research and development efforts, Puma Biotechnology aims to make a significant impact in the field of oncology.

For more information about Puma Biotechnology and its innovative products, please visit their official website.