Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology
company focused on developing precision therapies for genetically
defined diseases, today announced updated clinical results from the
Open Label Extension (OLE) portion of SUMMIT, a clinical trial
evaluating bezuclastinib in patients with nonadvanced systemic
mastocytosis (NonAdvSM). The OLE data are being presented at the
66th American Society of Hematology (ASH 2024) Annual Meeting &
Exposition taking place December 7-10, 2024 in San Diego, CA.
“The rapid, deep, and sustained symptomatic improvement reported
by SUMMIT patients receiving bezuclastinib is very impressive,”
said Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of
Leukemia at the Dana-Farber Cancer Institute and Professor of
Medicine, Harvard Medical School. “Coupled with its favorable
tolerability profile, bezuclastinib has clear potential to
establish itself as the best-in-class KIT inhibitor for systemic
mastocytosis patients.”
“The SUMMIT data reported today are encouraging to thousands of
NonAdvSM patients around the world who are waiting for a novel
treatment that can rapidly and meaningfully improve a wide variety
of symptoms that impact their daily lives,” said Andrew Robbins,
Cogent’s President and Chief Executive Officer. “We set out earlier
this year to enroll our registration-directed SUMMIT Part 2 trial,
and I’m excited to announce that based on the overwhelming demand
from investigators and patients around the world, we’ve completed
enrollment in the study with 179 patients more than six months
ahead of schedule. Top-line results are now expected in July 2025,
meaning we have dramatically accelerated our timeline as we aim to
make bezuclastinib available to all NonAdvSM patients.”
Patient DemographicsSUMMIT is a
registration-directed, randomized, double-blind,
placebo-controlled, global, multicenter, clinical trial of
bezuclastinib in patients with NonAdvSM. In SUMMIT Part 1, patients
received bezuclastinib or placebo for a 12-week period to determine
the recommended dose for use in the pivotal portion of the trial,
SUMMIT Part 2. Earlier this year, Cogent announced that the
recommended go-forward dose was selected at once-daily 100 mg.
After the initial 12-week period, all patients were given the
opportunity to receive bezuclastinib in the SUMMIT Open Label
Extension (OLE). The clinical results presented today focus on 27
patients in the OLE who were treated with the once-daily 100 mg
dose of bezuclastinib. The median age of patients at study entry
was 52 years (ranging from 36-76 years). One patient had received
prior avapritinib.
Patient Reported Outcomes (PRO) DataSUMMIT
patients were evaluated for signs of clinical activity over 24
weeks using multiple PRO measures, including the Mastocytosis
Symptom Severity Daily Diary (MS2D2) and the Mastocytosis
Quality-of-Life (MC-QoL) scale. Updated clinical data presented
today show:
- 56% mean improvement in Total Symptom Score (TSS) at 24
weeks
- 76% of patients demonstrated >50% reduction from baseline in
MS2D2 Total Symptom Score (TSS) with 88% of patients exceeding 30%
reduction from baseline after 24 weeks
- 49% mean improvement in MC-QoL Total Score at 24 weeks
At 24 weeks of treatment, 31% of patients have already reduced
or discontinued best supportive care (BSC) medications.
Pharmacodynamic DataBezuclastinib showed rapid,
deep, and sustained reductions in serum tryptase over the course of
24 weeks of treatment including:
- 89% of patients had >50% decrease in serum tryptase levels
by four weeks of treatment
- 95% of patients with baseline tryptase ≥20ng/mL achieved
<20ng/mL by week 24
- 84% of patients with baseline serum tryptase >11.4ng/ml
achieved <11.4ng/mL by week 24
Safety DataAs of the data cutoff, August 29,
2024, the median duration of bezuclastinib treatment was 56 weeks
for patients in the active arm and 40 weeks for placebo patients
who crossed over to the OLE. The majority of treatment emergent
adverse events were low grade and reversible with no
treatment-related bleeding or cognitive impairment events reported.
The most common treatment related adverse events were hair
discoloration and transaminase elevations. All patients
experiencing elevated transaminases were asymptomatic and
reversible: five patients resolved without any dose modifications
and remain on study; two patients resolved with dose reduction and
remain on study, one of whom re-escalated to original dose; and two
patients resolved following discontinuation, one of whom was
presented previously at ASH 2023. There were no other
discontinuations due to adverse events.
SUMMIT Enrollment UpdateCogent also announced
today that enrollment in the registration-directed SUMMIT Part 2
study is now complete. In the nine months between February and
October 2024, 265 NonAdvSM patients were screened for SUMMIT Part 2
at 70 clinical sites, concentrated predominantly in the U.S. and
Western Europe. More than 90% of these patients were naïve to KIT
inhibitor therapy. A total of 179 patients were enrolled and
top-line results from the trial are expected in July 2025.
Webcast Information and ASH PosterCogent will
host a webcast today, Monday, December 9, 2024, at 8:00 a.m. ET to
discuss these updated SUMMIT clinical results. The live event will
be available on the Investors & Media page of Cogent’s website
at investors.cogentbio.com. A replay of the webcast will be
available approximately two hours after the completion of the event
and will be archived for up to 30 days. The ASH poster is
available to registered conference attendees and is also in the
Posters and Publications section of Cogent’s website at
www.cogentbio.com/research.
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, PI3Kα and KRAS. 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 company’s expectation to
present top-line results from SUMMIT Part 2 in July 2025; the
potential for bezuclastinib to establish itself as the
best-in-class KIT inhibitor for systemic mastocytosis patients; and
the company’s goal of making bezuclastinib available to all
NonAdvSM patients. 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
Cogent Biosciences (NASDAQ:COGT)
過去 株価チャート
から 11 2024 まで 12 2024
Cogent Biosciences (NASDAQ:COGT)
過去 株価チャート
から 12 2023 まで 12 2024