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Novartis, Kura Oncology Partner on Phase I/II Head and Neck Cancer Study of Piqray, Tipifarnib

NEW YORK – Novartis and Kura Oncology on Tuesday said they are studying the combination of Kura's HRAS inhibitor tipifarnib and Novartis' PI3K inhibitor alpelisib (Piqray) in head and neck squamous cell cancer patients whose tumors have HRAS overexpression, or PIK3CA mutations or amplification.

The companies expect to begin the Phase I/II KURRENT trial in the second half of 2021. Researchers will evaluate the combination's safety and anti-tumor activity and determine its recommended Phase II dose.

Tumors in around 50 percent of head and neck cancer patients rely on the HRAS or PI3K-alpha pathways, or both, to proliferate. "Combining tipifarnib with alpelisib has the potential to provide a clinically meaningful increase in anti-tumor activity compared to when inhibiting either pathway alone," Stephen Dale, chief medical officer of Kura, said in a statement. "We believe this clinical collaboration will enable us to potentially expand the use of tipifarnib to a significantly higher percentage of patients with advanced HNSCC."

Under the collaboration, Kura retains global development and commercial rights to tipifarnib. Kura is also studying tipifarnib as a monotherapy in a Phase II registrational study in HRAS-mutant head and neck cancer patients. Tipifarnib received breakthrough therapy designation from the US Food and Drug Administration in this indication in February.

The company also has ongoing studies of tipifarnib in angioimmunoblastic T-cell lymphoma and in HRAS-mutated urothelial cancer.

Novartis' alpelisib was approved in the US in 2019 as a treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer patients. Last year, alpelisib was also approved in Canada and the EU in this setting.