Repotrectinib continued to demonstrate high
response rates and durable responses, including robust intracranial
responses, in patients with ROS1-positive locally advanced or
metastatic non-small cell lung cancer who were TKI-naïve or
previously treated with one TKI and no chemotherapy
Median duration of response and
progression-free survival to be disclosed for the first time in the
pooled Phase 1/2 population alongside updated results at the IASLC
2023 World Conference on Lung Cancer hosted by the International
Association for the Study of Lung Cancer
Bristol Myers Squibb (NYSE: BMY) today announced updated results
from the registrational TRIDENT-1 study, demonstrating that
repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor
(TKI), continued to show high response rates and durable responses
in patients with ROS1-positive locally advanced or metastatic
non-small cell lung cancer (NSCLC). Updated results will be
featured in an oral presentation (Abstract #OA03.06) at the IASLC
2023 World Conference on Lung Cancer (#WCLC23) hosted by the
International Association for the Study of Lung Cancer on September
10, 2023, from 1:02 a.m. to 1:12 a.m. EDT / 1:02 p.m. to 1:12 p.m.
SGT.
Based on results from the TRIDENT-1 trial, the U.S. Food and
Drug Administration accepted the New Drug Application for
repotrectinib for the treatment of patients with ROS1-positive
locally advanced or metastatic NSCLC and granted Priority Review; a
Prescription Drug User Fee Act goal date of November 27, 2023 was
assigned.
In this updated analysis, repotrectinib continued to demonstrate
durable efficacy in patients with ROS1-positive NSCLC, including
intracranial activity, in patients who were TKI-naïve or previously
treated with one TKI and no chemotherapy. Median duration of
response (DOR) and median progression-free survival (PFS) will also
be disclosed for the first time in the pooled Phase 1 and Phase 2
population of patients with ROS1-positive NSCLC:
- In TKI-naïve patients (n=71) with median follow-up of 24.0
months, confirmed objective response rate (cORR) by Blinded
Independent Central Review (BICR) was 79%, median DOR and PFS were
34.1 months and 35.7 months, respectively. In patients with
measurable brain metastases at baseline (n=9), intracranial ORR per
BICR was 89% and responses were prolonged.
- In patients who had been previously treated with one TKI and no
chemotherapy (n=56) with median follow-up of 21.5 months, cORR by
BICR was 38%, and median DOR and PFS were 14.8 months and 9.0
months, respectively. In this subset of patients with measurable
brain metastases at baseline (n=13), intracranial ORR per BICR was
38%.
- At the recommended dose for Phase 2, the safety profile of
repotrectinib was manageable and remained consistent with previous
reports.
“The data from the TRIDENT-1 trial hold great significance in
the field of non-small cell lung cancer research, as they add to
the growing body of evidence pointing toward durable results with
repotrectinib in patients who test positive for ROS1 gene fusions,”
said Byoung Chul Cho, M.D., Ph.D., Yonsei Cancer Center, Yonsei
University College of Medicine, DAAN Cancer Laboratory. “With these
results, we are seeing durable benefit, including in the brain, in
patients with ROS1-positive NSCLC that differentiates repotrectinib
from existing agents and is especially impressive in the context of
historic data with current ROS1 TKIs. This targeted therapy has
true potential to change the treatment landscape and become a new
standard of care for patients with ROS1-positive NSCLC.”
“These updated results reflect the potential of repotrectinib as
a best-in-class ROS1 inhibitor. Furthermore, the data offer hope
for the patients with ROS1-positive non-small cell lung cancer who
still face high remaining unmet needs,” said Joseph Fiore,
executive director, global program lead, repotrectinib, Bristol
Myers Squibb. “Building on our heritage of transformational science
with immunotherapy in the treatment of NSCLC, we are excited to
advance this next-generation precision medicine, which has shown an
unprecedented level of durability of responses and robust
intracranial responses in patients with ROS1-positive NSCLC, so
that it can hopefully help patients in their fight against
cancer.”
The study remains ongoing to assess long-term outcomes and
additional endpoints across patient populations with ROS1-positive
locally advanced or metastatic NSCLC and NTRK-positive advanced
solid tumors. Bristol Myers Squibb thanks the patients and
investigators involved with the TRIDENT-1 clinical trial.
Turning Point Therapeutics is a wholly owned subsidiary of the
Bristol-Myers Squibb Company. As of August 2022, Bristol Myers
Squibb acquired the leading clinical stage precision oncology
company and its pipeline of investigational drugs across precision
oncology and advanced solid tumors, including repotrectinib.
About TRIDENT-1
TRIDENT-1 is a Phase 1/2 open-label, global, multi-center,
first-in-human clinical trial evaluating the safety, tolerability,
pharmacokinetics and anti-tumor activity of repotrectinib
(TPX-0005, BMS-986472) in patients with advanced solid tumors,
including non-small cell lung cancer (NSCLC). Phase 1 of the trial
includes several primary and secondary safety and pharmacokinetics
endpoints. Phase 2 of the trial has a primary endpoint of overall
response rate (ORR) as assessed by Blinded Independent Central
Review (BICR) using RECIST v1.1 and key secondary endpoints
including duration of response (DOR), time to response (TTR),
progression-free survival (PFS), overall survival (OS) and clinical
benefit rate (CBR) in six distinct expansion cohorts, including
tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients
with ROS1-positive locally advanced or metastatic NSCLC and
NTRK-positive advanced solid tumors.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally.
Non-small cell lung cancer (NSCLC) is one of the most common types
of lung cancer, representing up to 84% of diagnoses. Survival rates
vary depending on the stage and type of the cancer when diagnosed.
ROS1 fusions are rare and occur in about 1-2% of patients with
NSCLC. Patients with tumors that are ROS1-positive tend to be
younger than the average patient with lung cancer, more often
female and may have little to no smoking history. Per international
treatment guidelines, ROS1 targeted agents are preferred in
patients with a tumor harboring this alteration.
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 scientific expertise,
cutting-edge capabilities and discovery platforms enable the
company to look at 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. Because as a leader in
cancer care, Bristol Myers Squibb is working to empower all people
with cancer to have a better future.
About Repotrectinib
Repotrectinib (TPX-0005, BMS-986472) is a next-generation,
potential best-in-class tyrosine kinase inhibitor (TKI) targeting
ROS1- or NTRK-positive locally advanced or metastatic solid tumors,
including non-small cell lung cancer (NSCLC), where there remain
significant unmet medical needs for patients. Repotrectinib was
designed to improve durability of response and with favorable
properties to enhance intracranial activity. It is being studied in
a registrational Phase 1/2 trial primarily in adults and a Phase
1/2 trial in pediatric patients.
In June 2017, repotrectinib was granted an Orphan Drug
designation by the U.S. Food and Drug Administration (FDA). Since
then, repotrectinib has demonstrated clinically meaningful results
and was granted three Breakthrough Therapy Designations (BTDs) by
the FDA for the treatment of patients with: ROS1-positive
metastatic NSCLC who have not been treated with a ROS1 TKI;
ROS1-positive metastatic NSCLC who have been previously treated
with one ROS1 TKI and who have not received prior platinum-based
chemotherapy; and advanced solid tumors that have an NTRK gene
fusion who have progressed following treatment with one or two
prior tropomyosin receptor kinase (TRK) TKIs (with or without prior
chemotherapy) and have no satisfactory alternative treatments.
Repotrectinib was also previously granted four fast-track
designations in patients with: ROS1-positive advanced NSCLC who
have been treated with disease progression following one prior line
of platinum-based chemotherapy and one prior line of a ROS1 TKI;
ROS1-positive advanced NSCLC who have not been treated with a ROS1
TKI; ROS1-positive advanced NSCLC who have been previously treated
with one ROS1 TKI and who have not received prior platinum-based
chemotherapy; and advanced solid tumors that have an NTRK gene
fusion who have progressed following treatment with at least one
prior line of chemotherapy and one or two prior TRK TKIs and have
no satisfactory alternative treatments.
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 future study results may not be consistent with results to
date, that repotrectinib may not receive regulatory approval for
the indication described in this release in the currently
anticipated timeline or at all, that any marketing approvals, if
granted, may have significant limitations on their use, and, if
approved, whether such product candidate for such indication
described in this release will be commercially successful. 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,
2022, 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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