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In our exclusive interview, Nabil F. Saba, MD, FACP, sheds light on the implications of targeting HRAS in head and neck squamous cell carcinoma, details the data that has been reported to date with tipifarnib, and shares his expectations for the ongoing KO-TIP-007 trial.
Welcome to Onclive On Air™! I’m your host today, Caroline Seymour.
OncLive On Air™ is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In today’s episode, we had the pleasure of speaking with Nabil F. Saba, MD, FACP, director of the Head and Neck Medical Oncology Program at Winship Cancer Institute of Emory University, and professor in the Department of Hematology and Medical Oncology and Department of Otolaryngology at Emory University School of Medicine, to discuss ongoing research with tipifarnib in HRAS-mutant head and neck squamous cell carcinoma.
Tipifarnib is a small molecule inhibitor of farnesyltransferase, which is a critical enzyme needed for HRAS activation. In December 2019, the FDA granted fast track designation to tipifarnib for the treatment of patients with HRAS-mutant head and neck squamous cell carcinoma after progression on platinum therapy.
Initial findings from the phase 2 KO-TIP-001 trial demonstrated encouraging antitumor activity in patients with recurrent and metastatic head and neck cancer with high HRAS-mutant variant allele frequency (VAF).
Now, the agent is under study in the phase 2 registrational KO-TIP-007 trial in patients with HRAS-mutant head and neck squamous cell carcinoma. The study has 2 cohorts: AIM-HN, which will include patients with high and low VAF HRAS mutations, and SEQ-HN. In AIM-HN, patients with HRAS-mutant head and neck squamous cell carcinoma will receive tipifarnib monotherapy twice a day orally at 600 mg on days 1 to 7 and days 15 to 21 of 28-day treatment cycles.
SEQ-HN is a parallel prospective observation cohort that will compare treatment outcomes with first-line systemic therapy and other demographic and clinical characteristics in patients with HRAS-mutant head and neck squamous cell carcinoma who enrolled in AIM-HN and a matched control set of patients with HRAS wild-type tumors.
In our exclusive interview, Saba shed light on the implications of targeting HRAS in head and neck squamous cell carcinoma, detailed the data that has been reported to date with tipifarnib, and shared his expectations for the ongoing KO-TIP-007 trial.