Kura Oncology announced positive results from its registration-directed Phase II AIM-HN trial for tipifarnib in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC).

The results will be presented at the 2023 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, on 21 October 2023.

Tipifarnib is a farnesyl transferase inhibitor (FTI), which is involved in cancer initiation and development. It was granted the breakthrough therapy designation by the US Food and Drug Administration (FDA). It is being evaluated for multiple indications.

Tipifarnib is expected to generate $83m in 2034, according to GlobalData’s Expiry Model. Kura has a market cap of $647.341m.

GlobalData is the parent company of Pharmaceutical Technology.

Trial results

The open-label pivotal Phase II trial (NCT03719690) enrolled 59 patients with HRAS mutant HNSCC who received prior platinum-based therapy. The results presented were from 50 patients and had a cut-off date of 15 June 2023.

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One patient achieved a complete response with tipifarnib, with nine patients showing a confirmed partial response, as per the independent review facility (IRF).

The overall response rate was 29% in second-line treatment. Tipifarnib was well tolerated, with about 10% of the patients having grade three or four treatment-related adverse events. 7% of the participants discontinued treatment due to adverse events.

“We believe these positive results from AIM-HN validate the therapeutic value of farnesyl transferase inhibition as we begin to execute our clinical development plan for our next-generation FTI, KO-2806,” said Kura CEO Troy Wilson in a press release.

In June, Kura reported positive Phase I/II trial (NCT04067336) data for its selective menin inhibitor ziftomenib in patients with relapsed/refractory NPM1-mutant acute myeloid leukaemia (AML).