First presentation of data from Phase 3
KRYSTAL-12 study showed statistically significant and clinically
meaningful improvement in progression-free survival with KRAZATI
compared to standard of care chemotherapy
Late-breaking data featured in an oral
presentation at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting
Bristol Myers Squibb (NYSE: BMY) today announced results from
the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib)
compared to standard of care chemotherapy in patients with locally
advanced or metastatic KRASG12C-mutated non-small cell lung cancer
(NSCLC) who had previously received platinum-based chemotherapy,
concurrently or sequentially with anti-PD-(L)1 therapy. At a median
follow-up of 9.4 months, KRAZATI demonstrated a statistically
significant and clinically meaningful improvement in
progression-free survival (PFS), the study’s primary endpoint, as
assessed by Blinded Independent Central Review (BICR) compared to
docetaxel (HR: 0.58; [95% CI, 0.45-0.76]; P <0.0001). Median PFS
was 5.5 months for KRAZATI compared to 3.8 months for docetaxel.
Overall response rate (ORR) as assessed by BICR was also
significantly higher with KRAZATI compared to docetaxel (32% vs 9%;
odds ratio, 4.68; P < 0.0001). The median duration of response
(mDOR) was 8.31 months (95% CI, 6.05–10.35) versus 5.36 months (95%
CI, 2.86–8.54), respectively.
KRAZATI demonstrated intracranial response among patients with
central nervous system (CNS) metastases at baseline, with a
response rate per BICR that was more than double that observed with
docetaxel (24% with KRAZATI vs. 11% with docetaxel).
The KRYSTAL-12 study remains ongoing to assess the additional
key secondary endpoint of overall survival.
No new safety signals were identified for KRAZATI, and the
safety data were consistent with the known safety profile.
Treatment-related adverse events (TRAEs) of any grade were reported
in 94% of patients treated with KRAZATI and 86.4% with docetaxel.
Grade ≥3 TRAEs occurred in 47% and 46% of patients,
respectively.
These data will be presented in a late-breaking oral
presentation during the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting on June 1 at 1:27 p.m. CDT (Abstract
LBA8509).
“Approximately 14% of all patients with advanced non-small cell
lung cancer carry the KRASG12C mutation, impacting thousands of
people worldwide,” said Tony Mok, M.D., Chairman of the Department
of Clinical Oncology and Li Shu Fan Medical Foundation Professor of
Clinical Oncology of the Faculty of Medicine at The Chinese
University of Hong Kong (CU Medicine). “These results from the
Phase 3 KRYSTAL-12 study reinforce adagrasib as a targeted option
for patients with KRASG12C-positive lung cancer after failing
standard first-line treatment.”
“The accelerated approval of KRAZATI from the FDA in 2022 was
welcome news for patients with KRASG12C-mutated locally advanced or
metastatic NSCLC. These confirmatory results further support
KRAZATI as an efficacious, targeted treatment option for these
patients,” said Abderrahim Oukessou, M.D., vice president, global
program lead, KRAZATI, Bristol Myers Squibb. “We look forward to
further sharing these results, while also continuing to evaluate
KRAZATI in other advanced KRASG12C-mutated solid tumors.”
In addition to KRASG12C-mutated NSCLC, KRAZATI and KRAZATI-based
combinations have shown encouraging, meaningful benefit in Phase 2
clinical trials across several tumors, including advanced
colorectal cancer, pancreatic cancer, and other solid tumors.
Bristol Myers Squibb thanks the patients and investigators
involved in the KRYSTAL-12 clinical trial.
This study was funded by Mirati Therapeutics, Inc., a Bristol
Myers Squibb company. KRAZATI is a registered trademark of Mirati
Therapeutics, Inc., a Bristol Myers Squibb company.
About KRYSTAL-12 KRYSTAL-12
is an open-label, multicenter, randomized Phase 3 study evaluating
KRAZATI compared to standard-of-care chemotherapy alone, in
patients with KRASG12C-mutated non-small cell lung cancer. The
primary endpoint of the study is progression-free survival (PFS) as
assessed by Blinded Independent Central Review (BICR). Secondary
endpoints included overall survival (OS), overall response rate
(ORR), duration of response (DOR), and safety.
About KRASG12C -Mutated Non-Small
Cell Lung Cancer Lung cancer is the leading cause of
cancer deaths globally. The two main types of lung cancer are
non-small cell and small cell. Non-small cell lung cancer (NSCLC)
is one of the most common types of lung cancer, representing up to
84% of diagnoses. KRASG12C is the most common KRAS mutation in
NSCLC, present in approximately 14% of patients with lung
adenocarcinoma, and is a biomarker of poor prognosis.
About KRAZATI® (adagrasib)
KRAZATI (adagrasib) is a highly selective and potent oral
small-molecule inhibitor of KRASG12C that 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. KRASG12C mutations act as oncogenic drivers and occur
in approximately 14% of non-small cell lung cancer, 3-4% of
colorectal cancer, and 1-2% of several other cancers.
In 2022, the U.S. Food and Drug Administration (FDA) granted
KRAZATI accelerated approval for treatment of adult patients with
KRASG12C-mutated locally advanced or metastatic 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).
KRAZATI continues to be evaluated as a monotherapy and in
combination with other anti-cancer therapies in patients with
advanced KRASG12C-mutated solid tumors, including NSCLC and
colorectal cancer (CRC).
Please see U.S. Full Prescribing Information for KRAZATI.
INDICATION
KRAZATI is indicated for the treatment of adult patients with
KRASG12C-mutated locally advanced or metastatic non-small cell lung
cancer, 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).
IMPORTANT SAFETY
INFORMATION
GASTROINTESTINAL ADVERSE REACTIONS
- In the pooled safety population, serious gastrointestinal
adverse reactions observed were gastrointestinal obstruction in
1.6%, including 1.4% grade 3 or 4, gastrointestinal bleeding in
0.5% of patients, including 0.5% grade 3, and colitis in 0.3%,
including 0.3% grade 3. In addition, nausea, diarrhea, or vomiting
occurred in 89% of 366 patients, including 9% grade 3. Nausea,
diarrhea, or vomiting led to dosage interruption or dose reduction
in 29% of patients and permanent discontinuation of KRAZATI in
0.3%
- Monitor and manage patients using supportive care, including
antidiarrheals, antiemetics, or fluid replacement, as indicated.
Withhold, reduce the dose, or permanently discontinue KRAZATI based
on severity
QTC INTERVAL PROLONGATION
- KRAZATI can cause QTc interval prolongation, which can increase
the risk for ventricular tachyarrhythmias (eg, torsades de pointes)
or sudden death
- In the pooled safety population, 6% of 366 patients with at
least one post-baseline electrocardiogram (ECG) assessment had an
average QTc ≥501 ms, and 11% of patients had an increase from
baseline of QTc >60 msec. KRAZATI causes concentration-dependent
increases in the QTc interval
- Avoid concomitant use of KRAZATI with other products with a
known potential to prolong the QTc interval. Avoid use of KRAZATI
in patients with congenital long QT syndrome and in patients with
concurrent QTc prolongation
- Monitor ECGs and electrolytes prior to starting KRAZATI, during
concomitant use, and as clinically indicated in patients with
congestive heart failure, bradyarrhythmias, electrolyte
abnormalities, and in patients who are taking medications that are
known to prolong the QT interval. Withhold, reduce the dose, or
permanently discontinue KRAZATI, depending on severity
HEPATOTOXICITY
- KRAZATI can cause hepatotoxicity
- In the pooled safety population, hepatotoxicity occurred in
37%, and 7% were grade 3 or 4. A total of 32% of patients who
received KRAZATI had increased alanine aminotransferase
(ALT)/increased aspartate aminotransferase (AST); 5% were grade 3
and 0.5% were grade 4. Increased ALT/AST leading to dose
interruption or reduction occurred in 11% of patients. KRAZATI was
discontinued due to increased ALT/AST in 0.5% of patients
- Monitor liver laboratory tests (AST, ALT, alkaline phosphatase,
and total bilirubin) prior to the start of KRAZATI, and monthly for
3 months or as clinically indicated, with more frequent testing in
patients who develop transaminase elevations. Reduce the dose,
withhold, or permanently discontinue KRAZATI based on severity
INTERSTITIAL LUNG DISEASE/PNEUMONITIS
- KRAZATI can cause interstitial lung disease (ILD)/pneumonitis,
which can be fatal. In the pooled safety population,
ILD/pneumonitis occurred in 4.1% of patients, 1.4% were grade 3 or
4, and 1 case was fatal. The median time to first onset for
ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was
discontinued due to ILD/pneumonitis in 0.8% of patients
- Monitor patients for new or worsening respiratory symptoms
indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold
KRAZATI in patients with suspected ILD/pneumonitis and permanently
discontinue KRAZATI if no other potential causes of ILD/pneumonitis
are identified
ADVERSE REACTIONS
- The most common adverse reactions (≥25%) are nausea, diarrhea,
vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal
impairment, edema, dyspnea, decreased appetite
FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
- Infertility: Based on findings from animal studies, KRAZATI may
impair fertility in females and males of reproductive
potential
Please see U.S. Full Prescribing Information for
KRAZATI.
Bristol Myers Squibb: Creating a Better
Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision —
transforming patients’ lives through science. The goal of the
company’s cancer research is to deliver medicines that offer each
patient a better, healthier life and to make cure a possibility.
Building on a legacy across a broad range of cancers that have
changed survival expectations for many, Bristol Myers Squibb
researchers are exploring new frontiers in personalized medicine
and, through innovative digital platforms, are turning data into
insights that sharpen their focus. Deep understanding of causal
human biology, cutting-edge capabilities and differentiated
research platforms uniquely position the company to approach cancer
from every angle.
Cancer can have a relentless grasp on many parts of a patient’s
life, and Bristol Myers Squibb is committed to taking actions to
address all aspects of care, from diagnosis to survivorship. As a
leader in cancer care, Bristol Myers Squibb is working to empower
all people with cancer to have a better future.
About Bristol Myers
Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding
Forward-Looking Statements This press release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 regarding, among other
things, the research, development and commercialization of
pharmaceutical products. All statements that are not statements of
historical facts are, or may be deemed to be, forward-looking
statements. Such forward-looking statements are based on current
expectations and projections about our future financial results,
goals, plans and objectives and involve inherent risks, assumptions
and uncertainties, including internal or external factors that
could delay, divert or change any of them in the next several
years, that are difficult to predict, may be beyond our control and
could cause our future financial results, goals, plans and
objectives to differ materially from those expressed in, or implied
by, the statements. These risks, assumptions, uncertainties and
other factors include, among others, that results of future
post-marketing studies will not be consistent with the results of
this study, that KRAZATI (adagrasib) may not be commercially
successful, that any marketing approvals, if granted, may have
significant limitations on their use, and, that continued approval
of KRAZATI may be contingent upon verification and description of
clinical benefit in additional confirmatory trials. No
forward-looking statement can be guaranteed. Forward-looking
statements in this press release should be evaluated together with
the many risks and uncertainties that affect Bristol Myers Squibb’s
business and market, particularly those identified in the
cautionary statement and risk factors discussion in Bristol Myers
Squibb’s Annual Report on Form 10-K for the year ended December 31,
2023, as updated by our subsequent Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and other filings with the Securities
and Exchange Commission. The forward-looking statements included in
this document are made only as of the date of this document and
except as otherwise required by applicable law, Bristol Myers
Squibb undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
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