SAN DIEGO, Oct. 22, 2018 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted
oncology company, today announced the presentation of updated data
from its ongoing Phase 2 clinical trial of sitravatinib in
combination with OPDIVO® (nivolumab) in non-small cell
lung cancer (NSCLC) patients with documented progression on prior
immune checkpoint inhibitor therapy. The data were presented today
in a Proffered Paper Session (oral presentation) at the European
Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany.
Highlights from the Proffered Paper Sessions (Oral
Presentations) at ESMO 2018
An ongoing Phase 2 study is evaluating the efficacy and safety
of sitravatinib in combination with OPDIVO® (nivolumab),
an anti-PD-1 immune checkpoint inhibitor, in patients with NSCLC
who have experienced documented disease progression following prior
treatment with an immune checkpoint inhibitor. As of the data
cutoff date of August 27, 2018:
- 56 patients were evaluable for response with at least one
radiographic scan. Patients had a median of two lines of previous
therapy.
- 45/56 of evaluable patients demonstrated tumor reductions.
- 18/56 of evaluable patients demonstrated tumor reductions of
greater than 30%.
- 16/56 of evaluable patients achieved a Partial Response (PR) or
Complete Response (CR).
-
- 9 confirmed PRs or CRs.
- 2 unconfirmed PRs or CRs that remain on trial awaiting
confirmation.
- 5 unconfirmed PRs or CRs that will not be confirmed.
- 26/56 evaluable patients remained on treatment at the time of
data cut-off including 8 responding patients.
- A preliminary Kaplan-Meier estimate of median duration of
response was greater than 9 months.
-
- 6 responding patients have been treated for more than 6
months.
- 2 responding patients have been treated for more than 12
months.
- The combination has been well-tolerated and most adverse events
(AEs) were Grade 1 or 2.
"To date, the combination of sitravatinib and nivolumab has
demonstrated a significant number of durable responses in patients
with advanced NSCLC who experienced disease progression following
prior checkpoint inhibitor therapy, which is one of the most
challenging clinical scenarios that we currently face for this
patient population," said Ticiana
Leal, M.D., Assistant Professor of Medicine, Thoracic
Oncology Program Leader at the University of
Wisconsin. "The results of the study are encouraging as it
continues to show a clinical benefit for these patients and has a
favorable safety profile."
Sitravatinib Registration Plans
The Company also provided an update on the regulatory pathway
for sitravatinib in checkpoint refractory NSCLC patients following
a successful end of phase 2 meeting with the U.S. Food and Drug
Administration (FDA). Based on guidance received from the FDA,
Mirati plans to initiate a Phase 3 randomized clinical trial in
second line patients comparing the combination of sitravatinib plus
a checkpoint inhibitor to docetaxel in patients whose tumors have
progressed on prior checkpoint inhibitor therapy.
- The trial will include an interim analysis of overall response
rate (ORR) as a surrogate endpoint to serve as the basis for
potential Subpart H accelerated approval. This interim analysis and
the use of a docetaxel control arm follows clear guidance from the
FDA.
- The primary endpoint of the final analysis for the Phase 3
clinical trial will be overall survival.
- The trial will enroll patients with NSCLC whose tumors have
progressed following treatment with a checkpoint inhibitor and
platinum-based chemotherapy.
- Patients will be randomized for treatment with either the
combination of sitravatinib with a checkpoint inhibitor or
single-agent docetaxel.
- The Company plans to initiate the pivotal Phase 3 in the first
half of 2019. Ultimately, the Company expects this trial to enable
a new drug application (NDA) for the treatment of NSCLC patients
whose tumors have progressed following treatment with a platinum
containing regimen and a checkpoint inhibitor.
"There are limited treatment options for NSCLC patients whose
tumors progress following checkpoint inhibitor therapy," said
Charles M. Baum, M.D., Ph.D.,
President and Chief Executive Officer, Mirati Therapeutics, Inc.
"Based on the data from our ongoing Phase 2 clinical trial we
believe that the planned Phase 3 clinical trial will demonstrate a
greater response rate and overall survival compared with the
historical clinical outcomes for late stage NSCLC patients treated
with single-agent docetaxel, where response rates range from 7-11%.
The combination of sitravatinib and nivolumab has continued to show
it is well tolerated with manageable side effects. We remain
encouraged by the frequency and duration of the responses observed
to date in this patient population with limited treatment options
where responses would not be expected from re-treatment with a
checkpoint inhibitor alone."
Investor Call and Webcast Information
After the oral presentation, Mirati will host a live conference
call and webcast, led by Dr. Charles
Baum, on Monday, October 22,
2018, at 2:00 p.m.
CEST/8:00 a.m.
EDT/5:00 a.m. PDT. The live
call can be accessed by dialing (866) 324-3683 (toll free) or (509)
844-0959 (international) and then using passcode 3890724. A
telephone replay will be made available by dialing (855) 859-2056
(toll free) or (404) 537-3406 (international) using conference
replay ID 3890724.
The call will also be webcast live through the "Investors"
section of the Mirati corporate website at
http://ir.mirati.com/events-and-presentations. A replay of the
webcast will be available on the Mirati website shortly after the
conclusion of the event.
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
enrolling patients whose tumors harbor specific mutations in the
CBL kinase. 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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