2022-10-26| Trials & Approvals

Kura Oncology Boasts Immunotherapy Preliminary Trial Data Success

by Max Heirich
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San Diego-based clinical-stage biopharmaceutical company, Kura Oncology, announced proof of mechanism for its Phase 1/2 clinical trial of tipifarnib in combination with alpelisib. The combined immunotherapy treats Head and Neck Squamous Cell Carcinoma.

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Positive Preliminary Immunotherapy Trial Data

Head and Neck Squamous Cell Carcinoma (HNSCC) is one of the most common forms of cancer worldwide, with around 500,000 new cases arising each year. The cancer forms in the squamous cells, located in the outermost layer of the skin. 

Though countless advances have been made by a number of researchers in the field of immunotherapy, HNSCC survivability remains poor; the median survival rate of patients is around 13-15 months. 

For treating this form of cancer, Kura developed a combination treatment of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a proven treatment for certain breast cancers. Kura launched the Phase ½ KURRENT-HN clinical trial with the goal of determining safety and recommended combination dosing of the drugs. The trial also aims to assess early anti-tumor activity. 

Despite the trial’s continued work, preliminary results arrived, demonstrating proof of mechanism for the HNSCC combined treatment. Kura highlighted a thirty-five-year-old patient under examination with stage III squamous cell carcinoma of the tonsils. After failing two prior treatments, when enrolled in KURRENT-HN the anonymous patient saw a 81% reduction in target lesions after one cycle of the treatments. Once the patient completed three cycles, that number increased to 84%. 

On the announcement, Stephen Dale, M.D., Chief Medical Officer of Kura Oncology, said, “These preliminary data from KURRENT-HN are encouraging, supporting the biologic rationale that combining a farnesyl transferase inhibitor with a PI3Kα inhibitor can achieve meaningful clinical responses in PIK3CA-dependent HNSCC. We are now working to identify a recommended Phase 2 dose and schedule for the combination and remain committed to bringing this important new treatment option to patients with recurrent or metastatic HNSCC who are in dire need of better therapies.”

With a trial end date of September 2024, the KURRENT-HN trial has yet to demonstrate its full results. However, based on the preliminary data, a successful turnout for the HNSCC combination treatment is not an unrealistic expectation.

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