Planned Subgroup Analysis of RAMP 201 Data
Showed Combination Demonstrated Robust Efficacy in Recurrent LGSOC
Regardless of Number and Class of Prior Therapies Including After
Poor Response to Prior Therapy
Late-Breaking Abstract Featured as an Oral
Presentation during a Plenary Session at the Annual Global Meeting
of the International Gynecologic Cancer Society
Verastem Oncology (Nasdaq: VSTM) (the “Company”), a
biopharmaceutical company committed to advancing new medicines for
patients with cancer, announced today results of the efficacy and
safety of avutometinib and defactinib in recurrent low-grade serous
ovarian cancer (LGSOC) following prior systemic therapy. The
results of this planned subgroup analysis of Part A of the Phase 2
RAMP 201 (ENGOT-ov60/GOG-3052) trial were presented as a
late-breaking abstract in an oral presentation during a plenary
session at the Annual Global Meeting of the International
Gynecologic Cancer Society (IGCS 2023) November 5-7, 2023, in
Seoul, Korea.
“Patients with recurrent LGSOC currently have no medicines
approved by the U.S. Food and Drug Administration and limited
treatment options for their disease,” said Rachel Grisham, M.D.,
Section Head, Ovarian Cancer and Director, Westchester Gynecologic
Medical Oncology at Memorial Sloan Kettering Cancer Center N.Y.,
and the lead U.S. investigator of RAMP 201. “The results from this
analysis are encouraging as the combination of avutometinib and
defactinib demonstrates robust efficacy in recurrent LGSOC
irrespective of the number of prior therapies, and for most of
which, response to previous therapy was poor.”
This planned subgroup analysis was performed to assess efficacy
(confirmed objective response rate (ORR) via blinded independent
central review per RECIST v1.1) and safety in prior lines of
therapy (LoT) (1-3 LoT, ≥4 LoT). The analysis also evaluated
efficacy in the context of best response to most recent prior
treatment in the metastatic/recurrent setting.
In the combination arm, the observed ORRs were consistent across
patients who received 1-3 (45.5%, 5/11, 95% CI 17-77) and ≥4 lines
of therapy (44.4%, 8/18, 95% CI 22-69). Prior to enrollment in RAMP
201, only 2/23 (8.7%) patients responded to their last prior
treatment in the metastatic/recurrent setting, whereas the
combination of avutometinib and defactinib yielded an ORR of 43.5%
(10/23) in this subgroup. The safety profiles of avutometinib and
defactinib were similar in the less and more heavily pretreated
subgroups and both analyses were consistent with previously
reported safety data. The majority of treatment-emergent adverse
events were mild to moderate.
Initial results of RAMP 201 Part A, presented at the American
Society for Clinical Oncology Annual Meeting in May 2023,
demonstrated an ORR of 45% (13/29) and tumor shrinkage in 86%
(25/29) of evaluable patients that were treated with the
combination of avutometinib and defactinib. Safety and tolerability
were favorable and consistent with previously reported data. As
previously announced, Verastem Oncology intends to file for
accelerated approval with the FDA for the combination of
avutometinib and defactinib based on mature data from the RAMP 201
trial, together with the results of the investigator-initiated
FRAME trial. The Company plans to initiate its Phase 3 confirmatory
trial (RAMP 301) of avutometinib and defactinib in LGSOC versus
standard of care (SOC) chemotherapy (pegylated liposomal
doxorubicin, paclitaxel, topotecan) or hormone therapy (letrozole,
anastrozole) before the end of the year.
Dr. Grisham is a paid consultant for Verastem Oncology.
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
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
inhibitors. The U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK clamp avutometinib, with
defactinib, its FAK inhibitor, for the treatment of all patients
with recurrent low-grade serous ovarian cancer (LGSOC) regardless
of KRAS status after one or more prior lines of therapy, including
platinum-based chemotherapy.
Verastem Oncology is currently conducting clinical trials with
its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part
of its (Raf And Mek Program). RAMP 301
is a Phase 3 confirmatory trial evaluating the combination of
avutometinib and defactinib versus standard chemotherapy or
hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 is
a Phase 2 registration-directed trial of avutometinib in
combination with defactinib in patients with recurrent LGSOC and
has completed enrollment in the dose optimization and expansion
phases and is enrolling for low-dose evaluation. Verastem Oncology
has established clinical collaborations with Amgen and Mirati to
evaluate LUMAKRAS™ (sotorasib) and KRAZATI™ (adagrasib) in
combination with avutometinib in KRAS G12C mutant NSCLC as part of
the RAMP 203 and RAMP 204 trials, respectively. Supported by the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical
trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage
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 novel small
molecule drugs that inhibit critical signaling pathways in cancer
that promote cancer cell survival and tumor growth, including
RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For
more information, please visit www.verastem.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements related to the potential clinical value of various of
its clinical trials. 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. Each forward-looking
statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statement.
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
occurrence of adverse safety events and/or unexpected concerns that
may arise from additional data or analysis or result in
unmanageable safety profiles as compared to their levels of
efficacy; 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
third-party payors (including government agencies) may not
reimburse; that there may be competitive developments affecting our
product candidates; that we may not attract and retain high quality
personnel; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; that
our product candidates will experience manufacturing or supply
interruptions or failures; 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; that our target market for our product
candidates might be smaller than we are presently estimating; that
we or Chugai Pharmaceutical Co., Ltd. will fail to fully perform
under the avutometinib license agreement; that we or our other
collaboration partners may fail to perform under our collaboration
agreements; 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 may not have sufficient cash to fund our
contemplated operations; 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 Secura Bio, Inc. will achieve the milestones that
result in payments to us under our asset purchase agreement with
Secura Bio, Inc.; that we will be unable to execute on our
partnering strategies for avutometinib in combination with other
compounds; 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, 2022 as filed with the Securities
and Exchange Commission (SEC) on March 14, 2023 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 Verastem Oncology 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/20231106345111/en/
Investors: Ryan Porter Argot Partners +1 212-600-1902
ryan.porter@argotpartners.com
Media: Lisa Buffington Corporate Communications +1
781-292-4502 lbuffington@verastem.com
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