Late-breaking abstract of the mature RAMP 201
data evaluating avutometinib plus defactinib in low-grade serous
ovarian cancer to be featured as oral plenary presentation
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced the acceptance of a late-breaking abstract of the
mature data from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052)
clinical trial to be presented as an oral presentation at a plenary
session at the International Gynecologic Cancer Society (IGCS)
Annual Meeting taking place October 16-18, 2024 in Dublin, Ireland.
The presentation will include updated safety and efficacy data from
the RAMP 201 trial evaluating the combination of avutometinib, a
RAF/MEK clamp, and defactinib, a selective FAK inhibitor, in
patients with low-grade serous ovarian cancer (LGSOC), including
overall response rate, progression free survival, and duration of
response.
“The robust interim data from the ongoing RAMP 201 clinical
trial in LGSOC, announced earlier this year, enabled us to initiate
the rolling NDA submission to the FDA,” said Dan Paterson,
president and chief executive officer of Verastem Oncology. “We
look forward to the oral presentation at IGCS of the mature RAMP
201 data and engaging with experts in ovarian cancer as part of the
international gynecologic community. We also remain on track to
finalize our clinical module and complete our NDA submission in the
fourth quarter of this year.”
About the Avutometinib and Defactinib Combination
Avutometinib is a RAF/MEK clamp that induces inactive complexes
of MEK with ARAF, BRAF and CRAF potentially creating a more
complete and durable anti-tumor response through maximal RAS/MAPK
pathway inhibition. In contrast to currently available MEK-only
inhibitors, avutometinib blocks both MEK kinase activity and the
ability of RAF to phosphorylate MEK. This unique mechanism allows
avutometinib to block MEK signaling without the compensatory
activation of MEK that appears to limit the efficacy of other
MEK-only inhibitors.
Verastem Oncology is currently conducting clinical trials with
avutometinib in RAS/MAPK driven tumors as part of its Raf
And Mek Program or RAMP. RAMP 301
(NCT06072781) is an international Phase 3 confirmatory trial
evaluating the combination of avutometinib and defactinib, a
selective FAK inhibitor, versus standard chemotherapy or hormonal
therapy for the treatment of recurrent low-grade serous ovarian
cancer (LGSOC). RAMP 201 (NCT04625270) is a Phase 2
registration-directed trial of avutometinib in combination with
defactinib in patients with recurrent LGSOC and enrollment has been
completed for the entire RAMP 201 trial, including regimen
selection and expansion of the go forward regimen.
Verastem has initiated a rolling New Drug Application (NDA)
submission to the U.S. Food and Drug Administration (FDA) for the
investigational combination of avutometinib and defactinib in
adults with recurrent LGSOC and expects to complete its NDA
submission in the second half of 2024 with a potential FDA decision
in the first half of 2025. The FDA granted Breakthrough Therapy
Designation of the investigational combination of avutometinib and
defactinib for the treatment of all patients with recurrent LGSOC
after one or more prior lines of therapy, including platinum-based
chemotherapy. Avutometinib alone or in combination with defactinib
was also granted Orphan Drug Designation by the FDA for the
treatment of LGSOC.
Verastem Oncology has established clinical collaborations with
Amgen and Mirati to evaluate LUMAKRAS™ (sotorasib) in combination
with avutometinib and defactinib and KRAZATI™ (adagrasib) in
combination with avutometinib in KRAS G12C mutant NSCLC as part of
the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials,
respectively. The RAMP 205 (NCT05669482), a Phase 1b/2 clinical
trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer, is supported by the PanCAN Therapeutic
Accelerator Award. FDA granted Orphan Drug Designation to
avutometinib and defactinib combination for the treatment of
pancreatic cancer.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a late-stage development
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with cancer. Our pipeline is focused on RAS/MAPK-driven
cancers, specifically novel small molecule drugs that inhibit
critical signaling pathways in cancer that promote cancer cell
survival and tumor growth, including RAF/MEK inhibition and FAK
inhibition. For more information, please visit www.verastem.com and
follow us on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking statements about,
among other things, Verastem Oncology’s programs and product
candidates, strategy, future plans and prospects, including
statements related to the timing and content of the presentation of
the mature data from the ongoing Phase 2 RAMP 201
(ENGOT-ov60/GOG-3052) clinical trial, the timing, scope and
progress of the rolling NDA submission for the avutometinib and
defactinib combination in LGSOC, the structure of our planned and
pending clinical trials, the potential clinical value of various of
the Company’s clinical trials, including the RAMP 201 trial, the
timing of commencing and completing trials, including topline data
reports, interactions with regulators, the timeline and indications
for clinical development, regulatory submissions and the potential
for and timing of commercialization of product candidates. The
words "anticipate," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," “can,” “promising” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
Forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that could
cause our actual results to differ materially from those expressed
or implied in the forward-looking statements we make. Applicable
risks and uncertainties include the risks and uncertainties, among
other things, regarding: the success in the development and
potential commercialization of our product candidates, including
avutometinib in combination with other compounds, including
defactinib, LUMAKRAS™ and others; the uncertainties inherent in
research and development, such as negative or unexpected results of
clinical trials, the occurrence or timing of applications for our
product candidates that may be filed with regulatory authorities in
any jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve any such applications that may be filed
for our product candidates, and, if approved, whether our product
candidates will be commercially successful in such jurisdictions;
our ability to obtain, maintain and enforce patent and other
intellectual property protection for our product candidates; the
scope, timing, and outcome of any legal proceedings; decisions by
regulatory authorities regarding trial design, labeling and other
matters that could affect the timing, availability or commercial
potential of our product candidates; whether preclinical testing of
our product candidates and preliminary or interim data from
clinical trials will be predictive of the results or success of
ongoing or later clinical trials; that the timing, scope and rate
of reimbursement for our product candidates is uncertain; that the
market opportunities of our drug candidates are based on internal
and third-party estimates which may prove to be incorrect; that
third-party payors (including government agencies) may not
reimburse; that there may be competitive developments affecting our
product candidates; that data may not be available when expected;
that enrollment of clinical trials may take longer than expected,
which may delay our development programs, including delays in
submission or review by the FDA of our NDA submission in recurrent
KRAS mutant LGSOC if enrollment in our confirmatory trial is not
well underway at the time of submission, or that the FDA may
require the Company to enroll additional patients in the Company’s
ongoing RAMP-301 confirmatory Phase 3 clinical trial prior to
Verastem submitting or the FDA taking action on our NDA seeking
accelerated approval; risks associated with preliminary and interim
data, which may not be representative of more mature data,
including with respect to interim duration of therapy data; that
our product candidates will cause adverse safety events and/or
unexpected concerns may arise from additional data or analysis, or
result in unmanageable safety profiles as compared to their levels
of efficacy; that we may be unable to successfully validate,
develop and obtain regulatory approval for companion diagnostic
tests for our product candidates that require or would commercially
benefit from such tests, or experience significant delays in doing
so; that the mature RAMP 201 data and associated discussions with
the FDA may not support the scope of our rolling NDA submission for
the avutometinib and defactinib combination in LGSOC, including
with respect to KRAS wild type LGSOC; that our product candidates
may experience manufacturing or supply interruptions or failures;
that any of our third party contract research organizations,
contract manufacturing organizations, clinical sites, or
contractors, among others, who we rely on fail to fully perform;
that we face substantial competition, which may result in others
developing or commercializing products before or more successfully
than we do which could result in reduced market share or market
potential for our product candidates; that we will be unable to
successfully initiate or complete the clinical development and
eventual commercialization of our product candidates; that the
development and commercialization of our product candidates will
take longer or cost more than planned, including as a result of
conducting additional studies or our decisions regarding execution
of such commercialization; that we may not have sufficient cash to
fund our contemplated operations, including certain of our product
development programs; that we may not attract and retain high
quality personnel; that we or Chugai Pharmaceutical Co., Ltd. will
fail to fully perform under the avutometinib license agreement;
that the total addressable and target markets for our product
candidates might be smaller than we are presently estimating; that
we or Secura Bio, Inc. (Secura) will fail to fully perform under
the asset purchase agreement with Secura, including in relation to
milestone payments; that we will not see a return on investment on
the payments we have and may continue to make pursuant to the
collaboration and option agreement with GenFleet Therapeutics
(Shanghai), Inc. (GenFleet), or that GenFleet will fail to fully
perform under the agreement; that we may be unable to obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will not pursue or submit
regulatory filings for our product candidates; and that our product
candidates will not receive regulatory approval, become
commercially successful products, or result in new treatment
options being offered to patients.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 as filed with the Securities
and Exchange Commission (SEC) on March 14, 2024 and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and the Company does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240910506625/en/
For Investor and Media Inquiries: Julissa Viana Vice
President, Corporate Communications and Investor Relations
investors@verastem.com or media@verastem.com
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