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Kura Oncology Begins Trial of Tipifarnib, Novartis' Piqray in Head and Neck Cancer

NEW YORK – Kura Oncology said on Thursday it has dosed the first patient in a Phase I/II trial of its farnesyltransferase inhibitor tipifarnib with Novartis' PI3K inhibitor alpelisib (Piqray) in HRAS- or PIK3CA-dependent head and neck cancer.

The San Diego-based company will enroll 40 patients in the KURRENT trial with recurrent or metastatic head and neck squamous cell carcinoma in two cohorts, one including patients who harbor PIK3CA mutations or amplifications and the other with patients whose tumors have HRAS overexpression.

Researchers will try to identify the recommended dose and evaluate the combination's safety and tolerability. Secondary endpoints in the trial are objective response rate, disease control rate, progression-free survival, and overall survival, along with pharmacokinetics.

"Despite the approval of immunotherapy, the treatment of recurrent and metastatic HNSCC remains a significant unmet need," Kura CEO Troy Wilson said in a statement. "The KURRENT trial builds on the impressive clinical activity reported for tipifarnib as a monotherapy in HRAS-mutant HNSCC and represents an opportunity to significantly expand the potential patient population and target mechanisms of drug resistance."

In a previous Phase II study of tipifarnib as a monotherapy in HRAS- or PIK3CA-dependent head and neck cancer, the drug demonstrated an overall response rate of 55 percent, a median progress-free survival of 5.6 months, and a median overall survival of 15.4 months. Kura is also studying tipifarnib in angioimmunoblastic T-cell lymphoma and in HRAS-mutated urothelial cancer.

Kura and Novartis announced a partnership earlier this year to study the combination of tipifarnib and alpelisib. Novartis' PI3K inhibitor is approved in the US, Europe, and Canada as a treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer patients.