Adagrasib is the first and only
KRASG12C inhibitor to prospectively demonstrate
intracranial (IC) activity in KRASG12C-mutated NSCLC
with untreated CNS metastases
Data demonstrate compelling clinical
activity; highlights promising and durable intracranial clinical
activity
Data follows recent inclusion of adagrasib
as first and only KRASG12C
inhibitor listed in National Comprehensive Cancer Network
(NCCN) Clinical Practice Guidelines in Oncology for CNS
Cancers
SAN
DIEGO, June 20, 2023 /PRNewswire/ -- Mirati
Therapeutics, Inc.® (NASDAQ: MRTX), a
commercial stage biotechnology company, announced today the
Journal of Clinical Oncology published clinical results from
the KRYSTAL-1 study of adagrasib, a potent and selective
KRASG12C inhibitor, demonstrating durable IC activity in
patients living with KRASG12C-mutated NSCLC with
untreated CNS metastases. This result is clinically meaningful as
CNS metastases are present in 27%-42% of patients living with
KRASG12C-mutated NSCLC at diagnosis and are linked to
worse prognosis and higher rates of disease progression in the CNS.
Read the publication, here.
Data with adagrasib from KRYSTAL-1 demonstrating the
first prospective evaluation of a KRASG12C inhibitor in
untreated CNS metastases were based on 25 enrolled patients (19
radiographically evaluable per CNS RECIST v1.1) who had received a
median of 1 prior systemic therapy. Results showed an IC objective
response rate (ORR) of 42% and IC disease control rate of 90%. High
concordance between IC and systemic activity was observed. The
median IC progression-free survival was 5.4 months and median
overall survival 11.4 months. Notably, findings demonstrate a
manageable safety profile consistent with previous reports of
adagrasib with few CNS-specific adverse events. The
publication of this data follows the recent inclusion of
adagrasib in the NCCN guidelines for CNS Cancers.
"We are pleased that JCO, the NCCN, and the oncology community
has recognized the importance and potential impact of
adagrasib's strong clinical results in patients living
with KRASG12C-mutated NSCLC with untreated CNS
metastases. This is a patient population with a high unmet need for
which few treatment options exist," said Alan Sandler, M.D., chief medical officer,
Mirati Therapeutics, Inc. "This practice-informing publication
reinforces the potential of adagrasib as a best-in-class
KRASG12C inhibitor and underscores its ability to drive
meaningful clinical activity in the CNS. We look forward to the
continued development of adagrasib for the potential benefit
of patients living with cancer."
About KRAZATI®
(adagrasib)
In the U.S., KRAZATI was approved by the FDA for Accelerated
Approval (Subpart H), which allows for the approval of drugs that
treat serious conditions, and that fill an unmet medical need based
on surrogate endpoints. KRAZATI was reviewed under the FDA
Real-Time Oncology Review (RTOR) pilot program, which aims to
explore a more efficient review process that ensures safe and
effective treatments are made available to patients as early as
possible. Mirati submitted a Marketing Authorization Application
(MAA) in the EU in May 2022. In
2021, adagrasib achieved Breakthrough Therapy
Designation in the U.S. as a potential treatment for patients with
NSCLC harboring the KRASG12C mutation who have
received at least one prior systemic therapy. For Prescribing
Information, visit Mirati.com/KRAZATI_USPI
Adagrasib continues to be evaluated as monotherapy
and in combination with other anti-cancer therapies in patients
with advanced KRASG12C-mutated solid tumors, including
NSCLC, colorectal cancer, and pancreatic cancer. For more
information, visit Mirati.com/science.
KRAZATI (adagrasib) U.S.
Indication
KRAZATI is indicated for the treatment of adult patients with
KRASG12C-mutated locally advanced or metastatic
non-small cell lung cancer (NSCLC), as determined by an
FDA-approved test, who have received at least one prior systemic
therapy.
This indication is approved under accelerated approval based on
objective response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon
verification and description of a clinical benefit in a
confirmatory trial(s).
About Mirati Therapeutics,
Inc.®
Mirati Therapeutics, Inc. is a commercial stage 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 related to the
impact COVID-19 could have on our business, and 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 (https://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
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