SAN DIEGO, Nov. 9, 2018 /PRNewswire/ -- Mirati Therapeutics, Inc. (MRTX), a clinical-stage targeted oncology company, announced preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab (OPDIVO®) in non-small cell lung cancer (NSCLC) patients at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting in Washington, D.C. The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th.
The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018 European Society for Medical Oncology (ESMO) Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today's presentation, "Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor", highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes.
The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.
"We are encouraged that we observed clear evidence of an adaptive immune response in our Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab. This suggests that the mechanism of sitravatinib is mediated, at least in part, by its effect on immune cell populations and that an anti-tumor immune response can be restored by sitravatinib administered with checkpoint therapy," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "We will continue to evaluate correlative endpoints as clinical trial data mature and determine whether biomarkers can be utilized to select patients who are most likely to benefit."
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 who have experienced documented disease progression following 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.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.
About Mirati Therapeutics
Mirati Therapeutics, Inc. is a clinical-stage oncology company developing product candidates to address the genetic, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who we believe would be most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where our product candidates have the potential to improve the immune environment of tumor cells and may enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. Our pre-clinical programs include potentially first-in-class and best-in-class product candidates specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better therapies and better outcomes for patients. For more information, visit www.mirati.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of Mirati Therapeutics, Inc. ("Mirati") that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding Mirati's development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati's product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Forward-looking statements are based on current expectations of management and on what management believes to be reasonable assumptions based on information currently available to them, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation potential delays in development timelines, negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks detailed in Mirati's recent filings on Forms 10-K and 10-Q with the U.S. Securities and Exchange Commission. Except as required by law, Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
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