On February 15, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported the presentation of initial data from an ongoing investigator sponsored Phase 1/2 clinical trial of sitravatinib in combination with nivolumab (OPDIVO) in patients with advanced clear cell renal cell cancer (aCCRCC) who have documented progression on a prior VEGF-targeted therapy (Press release, Mirati, FEB 15, 2020, View Source [SID1234554378]). The data were presented today in an oral abstract presentation by Pavlos Msaouel, M.D., Ph.D., Assistant Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, at the 2020 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in San Francisco, CA.
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"The initial efficacy data from the Phase 1/2 clinical trial presented today demonstrates encouraging durable responses, when compared with progression-free survival rates expected with nivolumab alone in aCCRCC patients that progressed on prior VEGF-targeted therapy," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "These data indicate the potential range of extended clinical benefit beyond checkpoint refractory non-small cell lung cancer and metastatic urothelial cancer."
As of the data cut-off date of January 1, 2020, 38 out of 40 patients enrolled were evaluable for response at greater than 12 weeks on therapy:
15/38 (39%) patients achieved a confirmed partial response (PR) including one PR that has improved to an unconfirmed complete response (CR)
35/38 (92%) patients achieved clinical benefit (combination of stable disease plus PR plus CR)
Initial median progression-free survival (PFS) was 10.3 months
Median overall survival (OS) has not yet been reached (median follow-up was 17.7 months) with 30/38 patients (79%) still on study as of the data cut-off date.
The combination has been well-tolerated with manageable adverse events.
About Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.