Data demonstrates compelling clinical
activity, highlights adagrasib potential as monotherapy in solid
tumors
Clinical data also presented at the ASCO
Plenary Series: April 2023
Session
Data follows recent inclusion of
KRAZATI® (adagrasib) in NCCN Guidelines for CNS
Cancers
SAN
DIEGO, April 26, 2023 /PRNewswire/ -- Mirati
Therapeutics, Inc.® (NASDAQ: MRTX), a
commercial stage biotechnology company, announced today the
Journal of Clinical Oncology published in a Rapid
Communication data indicating adagrasib, a potent and
selective KRASG12C inhibitor, is well tolerated and
demonstrates meaningful clinical activity in patients with
pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer
(BTC), and other solid tumors harboring a KRASG12C
mutation. Rapid Communications are reserved for publications deemed
to represent timely and late breaking research that may have an
immediate impact on patient care.
In addition, findings were presented last week at the April
session of the American Society of Clinical Oncology (ASCO) Plenary
Series Program. This publication follows the recent inclusion of
KRAZATI® (adagrasib) in the National
Comprehensive Center Network (NCCN) Guidelines for Central Nervous
System (CNS) Cancers for patients living with previously treated
KRASG12C-mutant non-small cell lung cancer (NSCLC) and
CNS metastases.
The Phase 2 data of the KRYSTAL-1 study demonstrates the
potential of adagrasib as a monotherapy in patients with
unresectable or metastatic KRASG12C-mutated solid tumors
beyond NSCLC and colorectal cancer (CRC). The data presented was
based on confirmed blinded, independent, central review (BICR)
responses. This is the largest Phase 2 dataset evaluating KRAS G12C
mutated solid tumors other than non-small cell lung cancer and
colorectal cancer.
The enrolled and treated population (n=63) included 21 PDAC, 12
BTC, 9 appendiceal adenocarcinoma, 4 gastroesophageal/esophageal
adenocarcinoma, 3 small bowel adenocarcinoma, 5 ovarian
adenocarcinoma, 4 unknown primary, 3 endometrial adenocarcinoma, 1
breast adenocarcinoma and 1 glioblastoma. The median prior lines of
systemic therapy was two. Results showed an objective response rate
(ORR) of 35% for the overall cohort. In patients with PDAC, ORR was
33%; for patients with BTC, ORR was 42%. Notably, findings
demonstrate the safety profile of adagrasib is aligned with
previously reported data in patients with pretreated NSCLC and
CRC.
These findings demonstrate a meaningful improvement relative to
the historically reported standard of care for PDAC and BTC. For
patients with previously treated metastatic PDAC, current standard
of care (gemcitabine + nab-paclitaxel or liposomal irinotecan +
5FU/leucovorin) has resulted in limited ORR (3-16%).1-2
In a biomarker-unselected BTC patient population, the ABC-06 phase
3 trial investigating FOLFOX in the second-line setting reported an
ORR of 5%.3
"We are thrilled to see the results of this Phase 2 study, which
demonstrate a marked improvement on the current standard of care
for patients with unresectable or metastatic
KRASG12C-mutated solid tumors, including PDAC, BTC,
other gastrointestinal (GI) and non-GI tumors, where few treatment
options exist. It is particularly encouraging to see meaningful
clinical activity in pancreatic and biliary tract cancers tumors,"
said Shubham Pant, M.D., M.B.B.S., The University of Texas MD Anderson Cancer Center. "The
data indicates that adagrasib has the potential to be
an effective treatment for KRASG12C-mutated solid tumor
types in addition to NSCLC and CRC."
"We're pleased to share this data which demonstrates meaningful
clinical activity in KRASG12C-mutated tumor types in
addition to NSCLC and CRC, indicating a potential path to
regulatory approval for adagrasib in additional
indications," said Alan Sandler,
M.D., chief medical officer, Mirati Therapeutics, Inc. "We look
forward to continuing to advance adagrasib as a potential
best-in-class treatment option for patients harboring a
KRASG12C mutation."
The primary endpoint for the Phase 2 cohort of the KRYSTAL-1
study was objective response rate. Secondary endpoints included
duration of response, progression-free survival, overall survival
and safety.
Findings were presented last week at the April session ASCO
Plenary Series Program as a data presentation (Abstract 425082)
titled, "KRYSTAL-1: Activity and Safety Of Adagrasib
(MRTX849) In Patients With Advanced Solid Tumors Harboring A
KRASG12C Mutation." The full abstract for the
presentation can be found here: Program Guide – ASCO Meeting
Program Guide.
The full Journal of Clinical Oncology article can be
found here.
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),
sitravatinib (TAM receptor inhibitor), 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. Wang-Gillam A,
Hubner RA, Siveke JT et al. NAPOLI-1 phase 3 study of liposomal
irinotecan in metastatic pancreatic cancer: Final overall
analysis and characteristics of long-term survivors. Eur J
Cancer 2019. 108:78-87
2. Huffman
BD, Basu Mallick
A, Horick NK, et al. Effect of
MUC5AC Antibody (NPC-1C) administered with second-line
gemcitabine and nab-paclitaxel on the survival
of patients with advanced pancreatic ductal
adenocarcinoma. JAMA Network Open
2023;6(1)e2249720
3. Lamarca A,
Palmer DH, Singh Wasan H, et
al. Second-line FOLFOX chemotherapy versus
active symptom control for advanced biliary tract
cancer (ABC-06): a phase 3 open-label, randomised,
controlled trial. Lancet Oncol
2021;22:690-701
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