SAN
DIEGO, Oct. 17, 2023 /PRNewswire/ -- Mirati
Therapeutics, Inc.® (NASDAQ: MRTX), a commercial
stage biotechnology company, today announced updated results from
the KRYSTAL-7 Phase 2 study evaluating adagrasib combined
with pembrolizumab in patients for the treatment of first-line
NSCLC harboring a KRASG12C mutation at the European
Society of Medical Oncology Congress (ESMO) 2023. These data
demonstrate a manageable safety profile and early signs of
durability of adagrasib in combination with a checkpoint
inhibitor in the first-line NSCLC setting.
Summary of Clinical Results
- In patients with PD-L1 TPS ≥50%, adagrasib and
pembrolizumab demonstrated an overall response rate (ORR) of 63%
and disease control rate (DCR) of 84% and promising early signs of
durability. The 63% confirmed response rate compares favorably to
pembrolizumab monotherapy which has demonstrated an ORR of
39-45%.1,2
- A median progression free survival has not been reached at 10.1
months median follow up.
- The safety profile of the adagrasib and pembrolizumab
combination was consistent with either agent as monotherapy, with a
low rate of treatment related adverse events (TRAEs) leading to
discontinuation of both drugs in only 4% of patients.
- Treatment related hepatic events occurred in <10% of
patients and were predominantly low grade. No patients discontinued
both adagrasib and pembrolizumab due to ALT/AST increase or
hepatic-related TRAEs.
"Data presented to date indicate that adagrasib
prescribed following or in combination with immunotherapy
offers a tolerable safety regimen for first-line NSCLC patients
with a KRASG12C mutation," said Marina C. Garassino, M.D., professor of
medicine, UChicago Medicine. "Adagrasib is the only
KRASG12C inhibitor to be feasibly combined concurrently
or following immunotherapy with a well-managed hepatoxicity
profile, and still exhibits positive efficacy signals."
"We are pleased to see these significant findings, which further
support the initiation of a global Phase 3 study evaluating the
combination of adagrasib plus immunotherapy in the
first-line setting for KRASG12C-mutated NSCLC with PD-L1
TPS ≥50% for the benefit of patients," said Alan Sandler, M.D., chief medical officer,
Mirati Therapeutics. "Potential combinability with an
immunotherapy, in addition to encouraging clinical activity in
other tumor types and demonstrated central nervous system (CNS)
penetration, reinforces our confidence in the differentiation of
adagrasib from other potential treatment options and the benefit it
offers to patients."
Mirati plans to initiate a Phase 3 clinical study to evaluate
adagrasib in combination with pembrolizumab in the first
line setting for KRASG12C-mutated NSCLC with PD-L1 TPS
≥50%. Initial patient enrollment is expected by year-end 2023.
About Mirati Therapeutics, Inc.®
Mirati
Therapeutics, Inc. is a commercial stage research and development
biotechnology company whose mission is to discover, design and
deliver breakthrough therapies to transform the lives of patients
with cancer and their loved ones. The company is relentlessly
focused on bringing forward therapies that address areas of high
unmet need, including lung cancer, and advancing a pipeline of
novel therapeutics targeting the genetic and immunological drivers
of cancer. Unified for patients, Mirati's vision is to unlock the
science behind the promise of a life beyond cancer.
For more information about Mirati, visit us
at Mirati.com or follow us
on Twitter, LinkedIn and Facebook.
Forward Looking Statements
This press release includes
forward-looking statements regarding Mirati's business, financial
guidance and the therapeutic and commercial potential of
KRAZATI® (adagrasib), MRTX1719 (MTA-cooperative PRMT5
inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective
KRASG12D inhibitor), Mirati's technologies and Mirati's other
products in development. Any statement describing Mirati's goals,
expectations, intentions or beliefs, financial or other
projections, is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to
certain risks and uncertainties, including those inherent in the
process of discovering, developing and commercializing medicines
that are safe and effective for use as human therapeutics, and in
the endeavor of building a business around such medicines.
Mirati's forward-looking statements also involve assumptions
that, if they never materialize or prove correct, could cause its
results to differ materially from those expressed or implied by
such forward-looking statements. Although Mirati's forward-looking
statements reflect the good faith judgment of its management, these
statements are based only on facts and factors currently known by
Mirati. As a result, you are cautioned not to rely on these
forward-looking statements. These and other risks concerning
Mirati's programs are described in additional detail in Mirati's
annual report on Form 10-K, and most recent Form 10-Q, which are on
file with the Securities and Exchange Commission and available at
the SEC's Internet site (www.sec.gov). These forward-looking
statements are made as of the date of this press release, and
Mirati assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could
differ from those projected in the forward-looking statements,
except as required by law.
Mirati Contacts
Investor Relations: ir@mirati.com
Media Relations: media@mirati.com
References
- Mok TSK, et al. Lancet 2019;393:1819–1830
- Reck M, et al. N Engl J Med 2016;375:1823–1833
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mirati-presents-late-breaking-results-evaluating-the-combination-of-adagrasib-and-pembrolizumab-in-first-line-non-small-cell-lung-cancer-nsclc-301959516.html
SOURCE Mirati Therapeutics, Inc.