SAN
DIEGO and ZUG, Switzerland, July 21,
2023 /PRNewswire/ -- Mirati Therapeutics,
Inc.® (NASDAQ: MRTX), a commercial stage biotechnology
company, today announced the European Medicine Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) issued a
negative opinion on the Conditional Marketing Authorisation
Application (MAA) for KRAZATI® (adagrasib) for
treatment of patients with KRASG12C -mutated advanced
non-small cell lung cancer (NSCLC).
Mirati disagrees with the opinion and intends to request a
formal re-examination.
CHMP states that KRAZATI has a positive risk-benefit profile,
however, does not fulfill certain requirements for a Conditional
Marketing Authorisation. Mirati believes KRAZATI addresses the
Conditional Marketing Authorisation requirements despite there
being a currently conditionally approved KRASG12C
inhibitor and that KRAZATI possesses a differentiated clinical
profile. Key differentiators include KRAZATI's efficacy profile,
potential central nervous system activity and combinability with
other agents, including concurrent with or following treatment with
an immune checkpoint inhibitor.
"We remain steadfast in our belief in the potential of
adagrasib to provide hope for patients in the European
Union," said David Meek, chief
executive officer, Mirati Therapeutics, Inc. "We will continue to
work closely with the EMA and the CHMP to bring adagrasib to
eligible patients. We are committed to delivering therapeutic
options for patients living with KRASG12C-mutated NSCLC
in the EU, as we have in the United
States following the Accelerated Approval of KRAZATI in
December 2022."
The MAA for KRAZATI was based on the Phase 2
registration-enabling cohort of the KRYSTAL-1 study, evaluating
KRAZATI 600 mg administered orally twice daily in 116 patients with
KRASG12C-mutated advanced NSCLC who previously received
treatment with a platinum-based regimen and an immune checkpoint
inhibitor.
Mirati is supplying KRAZATI to eligible European patients with a
KRASG12C mutation based on individual requests from
healthcare professionals. Mirati intends to continue supplying
KRAZATI under early access in EU Member States in alignment with
applicable laws and regulations.
This decision will have no impact on any of Mirati's clinical
trials. Study enrollment for KRYSTAL-12, the confirmatory
Phase 3 trial evaluating adagrasib versus docetaxel in
patients who have been previously treated for metastatic NSCLC with
a KRASG12C mutation, is progressing as
expected. Progression-free survival and interim overall survival
results are anticipated in the first half of 2024.
About KRAZATI (adagrasib)
Mirati has risen to meet one of the most challenging mutations
in cancer research by developing KRAZATI, a highly selective and
potent oral small-molecule inhibitor of KRASG12C.
Intentionally designed to meet the challenge of
KRASG12C, adagrasib is optimized to sustain
target inhibition, an attribute that could be important to
treat KRASG12C-mutated cancers, as the
KRASG12C protein regenerates every 24−48
hours.1 Adagrasib has shown clinically to be a
CNS penetrant, which may be important given that CNS metastases
frequently occur in NSCLC and lead to poor
prognosis.2,3,4
The FDA provided KRAZATI Accelerated Approval (Subpart H),
allowing for the approval of drugs that treat serious conditions,
and that fill an unmet medical need based on surrogate endpoints.
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.
About the KRYSTAL-1 Study
KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion
cohort trial evaluating adagrasib as monotherapy
and in combination with other anti-cancer therapies in patients
with advanced solid tumors harboring
the KRASG12C mutation.
About KRASG12C in NSCLC
Lung cancer is one of the most common cancers worldwide,
accounting for 2.21 million new cases and 1.8 million deaths
worldwide in 2020.5 Lung cancer consists of NSCLC in
approximately 85% of cases and small cell lung cancer (SCLC) in
approximately 15% of cases.6 KRASG12C is
the most common KRAS mutation in NSCLC, present in
approximately 14% of patients with lung adenocarcinoma, and is a
biomarker mutation of poor
prognosis.1,3
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
References
1 Hallin J, Engstrom LD, Hargis L, et al. The
KRASG12C Inhibitor MRTX849 Provides Insight toward
Therapeutic Susceptibility of KRAS-Mutant Cancers in Mouse Models
and Patients. Cancer Discov. 2020;10(1):54-71.
2 Sabari JK, Velcheti V, Shimizu K, et al. Activity of
Adagrasib (MRTX849) in Brain Metastases: Preclinical Models and
Clinical Data from Patients with KRASG12C-Mutant Non-Small Cell
Lung Cancer. Clin Cancer Res.
2022;28(15):3318-3328.
3 Cagney DN, Martin AM, Catalano PJ, et al. Incidence
and prognosis of patients with brain metastases at diagnosis of
systemic malignancy: a population-based study. Neuro Oncol.
2017;19(11):1511-1521.
4 Ali A, Goffin JR, Arnold A, Ellis PM. Survival of
patients with non-small-cell lung cancer after a diagnosis of brain
metastases. Curr Oncol. 2013;20(4):e300-6.
5 Lung cancer statistics. WCRF International.
https://www.wcrf.org/cancer-trends/lung-cancer-statistics/.
Published April 14, 2022.
6 Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA.
Non-small cell lung cancer: epidemiology, risk factors, treatment,
and survivorship. Mayo Clin
Proc. 2008;83(5):584-94.
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