SAN DIEGO, Nov. 9, 2018 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: 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."
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 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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