SAN
DIEGO and ZUG, Switzerland, Jan. 10,
2024 /PRNewswire/ -- Mirati Therapeutics,
Inc.® (NASDAQ: MRTX), a commercial stage biotechnology
company, today announced that the European Commission (EC) granted
conditional marketing authorization for KRAZATI®
(adagrasib) as a targeted treatment option for adult
patients with KRASG12C -mutated advanced non-small cell
lung cancer (NSCLC) and disease progression after at least one
prior systemic therapy.
KRAZATI has demonstrated a positive benefit-risk profile 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. The primary efficacy endpoints were
confirmed ORR and DOR as evaluated by blinded independent central
review (BICR) according to response evaluation criteria in solid
tumors (RECIST v1.1).
"KRAZATI offers an efficacious and tolerable therapeutic option
for patients living with advanced KRASG12C -mutated
NSCLC and this approval expands the potential treatment options
available," Martin Reck, MD, PhD,
Lung Clinic Grosshansdorf, Germany. "With it's differentiated profile,
KRAZATI offers an impactful treatment option for patients living
with lung cancer. This approval will assist physicians in tailoring
treatment approaches for patients."
Conditional marketing authorization for KRAZATI is valid in all
27 EU member states plus Iceland,
Norway and Liechtenstein. This authorization follows the
positive opinion adopted by the Committee for Medicinal Products
for Human Use (CHMP) in November
2023.
"This is a meaningful day for patients living with this
difficult-to-treat cancer in the European Union as we can now offer
a differentiated and potentially best-in-class therapeutic option
to this underserved population," Charles
Baum, M.D., PhD, founder, president and chief executive
officer, Mirati Therapeutics, Inc., "Mirati is resolute in our
commitment to improve upon treatment options for these patients and
looks forward to continued partnership with EU members states to
create broad access for all qualified patients."
Mirati thanks the patients, physicians, investigators and site
coordinators who participated in the clinical trials that led to
this important approval.
Important Safety Information
The Summary of Product Characteristics (SmPC) for KRAZATI
(adagrasib) will be available from the European Medicines Agency at
the Union Register of medicinal products.
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.2-34
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 (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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