The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tipifarnib for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma with variant allele frequency greater than or equal to 20% after disease progression on platinum-based chemotherapy.

Tipifarnib is an oral potent, selective inhibitor of farnesyl transferase. The designation is based on data from the single-arm, open-label phase 2 RUN-HN study (ClinicalTrials.gov: NCT02383927) that evaluated tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma whose disease had progressed after prior therapy.

Findings from the study showed that among 18 patients evaluable for efficacy, the objective response rate was 50% (95% CI, 26-74) with a median duration of response of 14.7 months. Additionally, median progression-free survival was 5.9 months (95% CI, 3.5-19.2) compared with 2.8 months on the patients’ prior therapy; median overall survival was 15.4 months (95% CI, 7.0-46.4).

The FDA previously granted Fast Track designation to tipifarnib for this indication. The Company is currently investigating tipifarnib for HRAS mutant head and neck squamous cell carcinoma in the phase 2 AIM-HN trial (ClinicalTrials.gov: NCT03719690).


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References

  1. Kura Oncology receives FDA Breakthrough Therapy designation for tipifarnib in head and neck squamous cell carcinoma. [press release]. San Diego, CA: Kura Oncology, Inc.; February 24, 2021. 
  2. Kura Oncology reports overall survival data from phase 2 trial of tipifarnib in HRAS mutant head and neck squamous cell carcinoma. [press release]. San Diego, CA: Kura Oncology, Inc.; May 29, 2020.