Kura Oncology's Head & Neck Cancer Candidate Shows Meaningful Antitumor Activity In Pretreated Patients

Kura Oncology Inc KURA announced results from its registration-directed AIM-HN study of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) whose disease is recurrent or metastatic (R/M) and has progressed after prior therapy.

These clinical results will be featured during a late-breaking oral session at the 2023 European Society for Medical Oncology (ESMO) Congress.

As of the data cutoff on June 15, 2023, 59 patients with R/M HRAS mutant HNSCC were enrolled, of whom 50 had high HRAS mutant variant allele frequency (VAF), and 38 were evaluable for efficacy. 

Both assessments by investigators and an independent review facility (IRF) observed one patient achieving a CR on treatment. 

Patients had a median of two prior lines of therapy in the recurrent/metastatic setting.

Robust activity was seen in second-line treatment and beyond, with greater activity observed in the second-line versus the third-line and subsequent treatments. 

The objective response rate (ORR) in second-line treatment was 29% in the independent review facility (IRF) assessment. The ORR for three FDA-approved therapies for HNSCC in the second line range from 13-16%.

Patients in the AIM-HN trial received tipifarnib at a dose of 600 mg orally twice daily on days 1-7 and 15-21 of 28-day cycles. 

Tipifarnib was generally well-tolerated with a manageable safety profile. The most common grade 3 or 4 treatment-related adverse events (TRAEs) seen in at least 10% of patients were cytopenias, and TRAEs led to treatment discontinuation in 7% of patients.

Price Action: KURA shares are up 0.34% at $8.75 on the last check Wednesday.