Kura Oncology Announces Publication of Tipifarnib Phase 2 Data in Journal of Clinical Oncology
Kura Oncology Announces Publication of Tipifarnib Phase 2 Data in Journal of Clinical Oncology
03-22-2021
– Phase 2 RUN-HN trial showed ORR of 55%, median PFS of 5.6 months and median OS of 15.4 months in recurrent/metastatic HRAS mutant HNSCC –
– Statistically significant improvement in median PFS compared with median PFS of 3.6 months on last prior therapy (p=0.0012) –
– Safety profile consistent with previously published data for tipifarnib –
– Results support continuation of AIM-HN registration-directed trial in HRAS mutant HNSCC –
As of the
Median progression-free survival (PFS) of 5.6 months (95% CI, 3.6 to 16.4) on tipifarnib was a statistically significant improvement over the median PFS of 3.6 months (95% CI, 1.3 to 5.2) on last prior therapy (p=0.0012). The median overall survival (OS) was 15.4 months (95% CI, 7.0 to 29.7). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab.
The ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months.
“We are encouraged by the compelling efficacy and safety profile of tipifarnib in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma,” said
Tipifarnib was generally well-tolerated in the trial. The most common grade 3 or 4 adverse events (AEs) seen in at least 10% of patients, were anemias and lymphopenias. Patients had received a median of two prior lines of systemic therapy (range 0-6; one patient received prior radiotherapy only), with 64% receiving prior immunotherapy, 50% receiving prior cetuximab, and 23% receiving both.
"We are pleased to see our data from the Phase 2 RUN-HN trial of tipifarnib published in the
The AIM-HN registration-directed trial of tipifarnib, in patients with recurrent or metastatic HRAS mutant HNSCC, is currently recruiting at more than 100 clinical sites in the U.S., Europe,
HRAS mutations occur in 4%-8% of patients with recurrent and/or metastatic HNSCC. The HRAS biomarker can be found on most commercially available genomic panels. More information about HRAS and biomarker testing is available at uncoverhras.com
About HNSCC
Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.
About Tipifarnib
Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to Breakthrough Therapy Designation, tipifarnib has been granted Fast Track designation by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. KO-539, a potent and selective menin inhibitor, is currently in a Phase 1/2 clinical trial (KOMET-001) and targeting patients with relapsed/refractory acute myeloid leukemia, including patients with NPM1 mutations. Tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant head and neck squamous cell carcinoma and is currently in a registration-directed study (AIM-HN) in patients with this devastating disease. Kura is also developing a next-generation farnesyl transferase inhibitor, which is intended to target innovative biology and larger oncology indications through rational combinations. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.
Disclosures
Memorial Sloan Kettering (MSK) has institutional financial interests related to the research in this release in the form of intellectual property rights and associated interests by virtue of licensing agreements between MSK and Kura.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s drug candidates, tipifarnib and KO-539, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, the strength of Kura’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its drug candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, the risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the
Contacts
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pete@kuraoncology.com
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1 HRAS variant allele frequency >35%, or ≥ 20% if serum albumin ≥ 3.5 g/dL
Source: Kura Oncology, Inc.