SAN DIEGO, Sept. 14, 2017 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted
oncology biotechnology company, announced that positive preliminary
data from two ongoing clinical trials of sitravatinib in non-small
cell lung cancer (NSCLC) will be presented Friday, September 15th, 2017 at the
IASLC 2017 Chicago Multidisciplinary Symposium in Thoracic Oncology
(learn more at www.iaslc.org).
Initial safety data and efficacy information will be presented
from the ongoing Phase 2 study of sitravatinib in combination with
nivolumab (OPDIVO®) as a treatment for NSCLC patients
with cancer progression following previous treatment with a
checkpoint inhibitor. Additionally, a case study will be presented,
documenting an objective response of a NSCLC patient with a
CBL inactivating mutation. This was the first evaluable
NSCLC patient harboring a CBL mutation treated in the
ongoing Phase 1b study of sitravatinib as a single agent. In both
clinical studies, sitravatinib alone and in combination with
nivolumab was well tolerated with a manageable safety profile.
"For the majority of NSCLC patients who progress following
checkpoint therapy, there is a need for new therapeutic options,"
said Charles M. Baum, M.D., Ph.D.,
President and Chief Executive Officer. "We are evaluating
sitravatinib in combination with nivolumab in this checkpoint
resistant population and are very encouraged by the responses
observed, since responses would not be expected from re-treatment
with a checkpoint inhibitor alone."
"In addition, in the single agent trial, the objective partial
response is the first example of clinical activity in a patient
with a CBL mutation. Inactivating mutations in CBL
occur in approximately 1.5% of NSCLC patients and currently
represent an unmet medical need."
Sitravatinib and Nivolumab Combination Study
Poster Presentation: Evidence of Clinical Activity of
Sitravatinib in Combination with Nivolumab in NSCLC Patients
Progressing on Prior Checkpoint Inhibitor Therapy
Clinical Trial: NCT02954991, A Phase 2 study evaluating
the tolerability and clinical activity of sitravatinib in
combination with nivolumab in patients with non-squamous NSCLC who
have experienced progression of disease on or after treatment with
checkpoint inhibitor therapy.
Presenter: Ticiana A.
Leal, M.D.
This presentation provides a preliminary safety and efficacy
update of the Phase 2 trial of sitravatinib in combination with
nivolumab in NSCLC patients who have experienced progression of
disease on or after treatment with checkpoint inhibitor therapy. In
the efficacy data presented, 3 patients experienced a confirmed
partial response out of 11 evaluable patients. Early safety data
demonstrated an acceptable profile and manageable adverse events.
Based on the data presented, the pre-defined criteria have been met
for expansion from stage 1 to stage 2, which will enroll a combined
total of 34 patients.
This study is designed to assess the potential of sitravatinib
to inhibit several important immunosuppressive pathways that may be
important in overcoming resistance to checkpoint inhibitor
therapy.
Sitravatinib Single Agent Study
Poster Presentation: CBL Mutations as Potential
Mediators of EGFR TKI Resistance Effectively Treated with
Sitravatinib
Clinical Trial: NCT02219711, A Phase 1b study evaluating
safety, PK, metabolism, PD and clinical activity of Sitravatinib in
patients with advanced solid tumor malignancies
Presenter: Lyudmila A.
Bazhenova. M.D.
The poster describes a case study of a NSCLC patient with a
CBL mutation treated with sitravatinib. CBL loss of
function mutations result in the increased activation of multiple
oncogenic receptor tyrosine kinases (RTKs) in tumors, including
PDGFRA, VEGFR2, KIT, Axl, and Mer. In preclinical models,
sitravatinib has demonstrated the ability to potently inhibit these
RTKs and induce tumor regression in NSCLC models harboring
inactivating CBL mutations. In the case study presented, a
heavily pre-treated NSCLC patient harboring an inactivating
CBL mutation was treated with sitravatinib and demonstrated
a confirmed partial response (PR) with a maximum decrease of 77% in
target lesions. Early safety data is also provided; sitravatinib
was well tolerated and the side effects observed were manageable.
This trial is on-going and actively recruiting patients harboring
CBL and other genetic mutations.
CBL mutations are present in 1.5% of NSCLC, 3.5% of melanoma,
and 2% of cancers of unknown origin.
Both posters will be available on the Company's website on the
sitravatinib page, located in the Pipeline section, at:
http://www.mirati.com/mgcd516/
About Sitravatinib
Sitravatinib (MGCD-0516) is a spectrum-selective kinase
inhibitor which potently inhibits receptor tyrosine kinases (RTKs)
including RET, TAM family receptors (TYRO3, Axl, Mer), and split
family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as
a single agent in a Phase 1b expansion trial enrolling patients
that harbor RET, CHR4Q12, and CBL genetic mutations in NSCLC
and other tumors.
As an immuno-oncology agent, sitravatinib is being tested in
combination with BMS' anti PD-1 checkpoint inhibitor nivolumab
(OPDIVO®) in NSCLC patients who have progressed after
prior treatment with a checkpoint inhibitor. Sitravatinib's potent
inhibition of TAM and split family receptors may help overcome
resistance to checkpoint inhibitor therapy through targeted
depletion of immunosuppressive Type 2 tumor associated macrophages,
regulatory T cells and myeloid-derived suppressor cells and
increasing antigen presentation capacity of dendritic cells in the
tumor microenvironment.
About Mirati Therapeutics
Mirati Therapeutics is a clinical-stage biotechnology company
focused on developing a pipeline of targeted oncology products
intended to treat specific genetic and epigenetic drivers of
cancer. This approach is transforming the treatment of patients by
targeting the genetic changes in tumor cells that result in
uncontrolled tumor growth and migration. Our precision oncology
programs seek to treat the patients most likely to benefit from
targeted oncology treatments and are driven by drugs that target
very specific genetic mutations, directed by genomic tests that
identify patients who carry those driver mutations. Our
immuno-oncology programs are novel small molecule drugs designed to
enhance and expand the efficacy of checkpoint inhibitors when given
in combination. In addition to our clinical programs, we have
active discovery research efforts focused on novel oncology
targets, including KRAS. The promise of these approaches
includes potentially better patient outcomes, more efficient cancer
treatment and faster drug development. 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 the Company that are not historical facts may be considered
"forward-looking statements," including, but not limited to,
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," "would," "believe,"
"intend," "plan," "anticipate," "estimate," "expect," and other
similar terminology. Forward-looking statements are based on
current expectations of management and upon what management
believes to be reasonable assumptions based on information
currently available to it, and are subject to risks and
uncertainties. Such risks and uncertainties may cause actual
results to differ materially from the expectations set forth in the
forward-looking statements. Such risks and uncertainties
include, but are not limited to, potential delays in development
timelines or 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
United States Securities and Exchange Commission. 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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SOURCE Mirati Therapeutics, Inc.