Daily Newsletter

19 October 2023

Daily Newsletter

19 October 2023

Kura aims for FDA approval with positive pivotal data for tipifarnib

The data from the Phase II trial showed the efficacy of tipifarnib in patients with recurrent/metastatic head and neck squamous cell carcinoma.

Phalguni Deswal October 18 2023

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.

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).

Significant unmet need in the Diabetic nephropathy (DN) market

With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.

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