Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology
company focused on developing precision therapies for genetically
defined diseases, today announced positive updated lead-in data
from the company’s ongoing Phase 3 PEAK trial evaluating the
selective and potent KIT mutant inhibitor, bezuclastinib, in
combination with sunitinib, in patients with Gastrointestinal
Stromal Tumors (GIST). The data will be presented in a poster
presentation at the American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago, IL on June 1. Cogent also announced
today a new Phase 2 clinical trial of bezuclastinib plus sunitinib
in later line GIST patients, sponsored by the Sarcoma Alliance
for Research through Collaboration (SARC) and in collaboration with
The Life Raft Group and Dana-Farber Cancer Institute.
“These data presented today reinforce our excitement that the
combination of bezuclastinib and sunitinib has the potential to
become a new standard of care for advanced GIST patients,” said
Andrew Robbins, President and Chief Executive Officer at Cogent
Biosciences. “Coupled with the impressive clinical activity
demonstrated by the combination, the addition of bezuclastinib to
sunitinib continues to be generally well-tolerated with an
encouraging safety profile. We are pleased to report that the pace
of enrollment in PEAK is significantly ahead of schedule, and we
now expect enrollment to complete in the third quarter of
2024.”
“We are also excited today to announce a collaboration with
SARC, The Life Raft Group and Dana-Farber on a new Phase 2 clinical
trial assessing the potential benefit of bezuclastinib with
sunitinib in later line GIST patients who are not eligible for the
PEAK study and currently have very limited treatment options,”
continued Mr. Robbins.
“There is tremendous need for additional treatment options for
GIST patients,” said Andrew Wagner M.D., Ph.D., Senior Physician,
Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute,
and Associate Professor of Medicine, Harvard Medical School.
“Today’s updated lead-in data from the bezuclastinib combination
are very promising, and I remain excited about the ongoing PEAK
trial. Additionally, with the announcement of this new study today,
we have a clinical trial which allows us to explore the use of
bezuclastinib with sunitinib in patients who are not eligible for
the PEAK study.”
PEAK Trial UpdatePEAK is a randomized,
open-label, global, Phase 3 clinical trial evaluating bezuclastinib
in combination with sunitinib vs sunitinib alone in GIST
patients previously treated with imatinib. In the updated lead-in
data being presented at ASCO, as of the cutoff date, April 1, 2024,
the 42 patients in Part 1 have been on study for a median of 15.3
months. The median progression-free survival (mPFS) during
treatment with bezuclastinib and sunitinib was 10.2 months in all
patients. In a subset of second-line GIST patients with only prior
imatinib, which most closely resembles patients currently enrolling
in Part 2 of PEAK, the data demonstrate a mPFS of 19.4 months. In
addition, the objective response rate (ORR) in all patients treated
with bezuclastinib and sunitinib was 27.5% and in the subset of
second-line patients the ORR was 33.3%, per investigator
assessment. Combination treatment resulted in a disease control
rate of 80% in all patients and 100% in patients with prior
imatinib only.
Safety DataAs of the data cutoff, the
combination of bezuclastinib and sunitinib does not appear
to add to the severity of adverse events known to be
associated with sunitinib monotherapy and is well-tolerated. The
majority of treatment-emergent adverse events (TEAEs) were
low-grade and reversible. No additional serious adverse reactions
or discontinuations due to TEAEs have been reported since the last
presentation of data in November 2023.
ASCO Poster DetailsTitle: Peak
part 1 summary: A phase 3, randomized, open-label multicenter
clinical study of bezuclastinib (CGT9486) and sunitinib combination
versus sunitinib in patients with gastrointestinal stromal tumors
(GIST)Session Type and Title: Poster Session –
SarcomaSession Date and Time: June 1, 2024,
1:30 PM-4:30 PM CDT
The poster will be available in the Posters and Publications
portion of the Cogent website at approximately 8:00 AM ET on June
1.
Phase 2 SARC TrialThe open label, single arm
Phase 2 trial sponsored by SARC and in collaboration with The Life
Raft Group and Dana-Farber Cancer Institute is designed to evaluate
the mPFS as well as the safety and tolerability of bezuclastinib
plus sunitinib in 40 patients with GIST who have previously
progressed on sunitinib. This trial will focus on later line
patients, where limited treatment options are available. Additional
details can be found on clinicaltrials.gov; Identifier NCT06208748.
For more information about SARC or The Life Raft Group, please
visit www.sarctrials.org or www.liferaftgroup.org.
Bezuclastinib Clinical DevelopmentEnrollment
continues in the Phase 3 registration-enabling PEAK study, which
will include approximately 388 second-line, post imatinib GIST
patients. Due to rapid enrollment, the Company now expects PEAK
enrollment to be completed in the third quarter of 2024 with
top-line results still expected by the end of 2025. Cogent remains
on-track to complete enrollment in APEX in patients with advanced
systemic mastocytosis (AdvSM) by the end of 2024 and report
top-line results mid-2025 and complete enrollment in SUMMIT Part 2
in the second quarter of 2025 and report top-line results by the
end of 2025.
Upcoming Investor ConferenceCogent will
participate in the Jefferies Global Healthcare Conference on
Wednesday, June 5 at 2:30 p.m. ET. A live webcast will be available
on the Investors & Media page of Cogent’s website at
investors.cogentbio.com/events. A replay will be available
approximately two hours after completion of the event and will be
archived for up to 30 days.
About Cogent Biosciences, Inc.Cogent
Biosciences is a biotechnology company focused on developing
precision therapies for genetically defined diseases. The most
advanced clinical program, bezuclastinib, is a selective tyrosine
kinase inhibitor that is designed to potently inhibit the KIT D816V
mutation as well as other mutations in KIT exon 17. KIT D816V is
responsible for driving systemic mastocytosis, a serious disease
caused by unchecked proliferation of mast cells. Exon 17 mutations
are also found in patients with advanced gastrointestinal stromal
tumors (GIST), a type of cancer with strong dependence on oncogenic
KIT signaling. In addition to bezuclastinib, the Cogent Research
Team is developing a portfolio of novel targeted therapies to help
patients fighting serious, genetically driven diseases initially
targeting mutations in FGFR2, ErbB2 and PI3Kα. Cogent Biosciences
is based in Waltham, MA and Boulder, CO. Visit our website for more
information at www.cogentbio.com. Follow Cogent Biosciences on
social media: X (formerly known as Twitter) and LinkedIn.
Information that may be important to investors will be routinely
posted on our website and X.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the long-term safety and
tolerability profile of the combination of bezuclastinib and
sunitinib therapy, the potential for the combination of
bezuclastinib and sunitinib to become a new standard of care for
advanced GIST patients, the updated guidance that the Company now
expects PEAK enrollment to be completed in the third quarter of
2024 with top-line results still expected by the end of 2025, the
expectation that PEAK will include approximately 388 second-line
post imatinib GIST patients, the expectation to complete enrollment
in APEX by the end of 2024 and to report top-line results mid-2025
and the expectation to complete enrollment in SUMMIT Part 2 in the
second quarter of 2025 and to report top-line results by the end of
2025. The use of words such as, but not limited to, "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "potential," "predict," "project,"
"should," "target," "will," or "would" and similar words
expressions are intended to identify forward-looking statements.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on our
current beliefs, expectations and assumptions regarding the future
of our business, future plans and strategies, our clinical results,
the rate of enrollment in our clinical trials and other future
conditions. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or
implied) are made about the accuracy of any such forward-looking
statements. We may not actually achieve the forecasts or milestones
disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Such
forward-looking statements are subject to a number of material
risks and uncertainties including but not limited to those set
forth under the caption "Risk Factors" in Cogent's most recent
Quarterly Report on Form 10-Q filed with the SEC. Any
forward-looking statement speaks only as of the date on which it
was made. Neither we, nor our affiliates, advisors or
representatives, undertake any obligation to publicly update or
revise any forward-looking statement, whether as result of new
information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date
hereof.
Contact:Christi WaarichSenior Director,
Investor Relationschristi.waarich@cogentbio.com617-830-1653
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