Registration-Directed RAMP-201 Trial Designed
to Address High Unmet Need in Low-Grade Serous Ovarian Cancer, a
Unique and Distinct Type of Ovarian Cancer with Limited Treatment
Options
Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced that an abstract highlighting updated interim
results from Part A of the ongoing Phase 2, registration-directed
RAMP 201 trial evaluating avutometinib (VS-6766) and defactinib in
patients with low-grade serous ovarian cancer (LGSOC) has been
selected for a presentation in a Poster Discussion Session at the
upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting taking place June 2–6, 2023 in Chicago, IL.
The objective of Part A (selection Phase) of the RAMP201 LGSOC
study was to determine the go forward regimen between avutometinib
monotherapy or the combination of avutometinib and defactinib to be
studied in Part B (expansion Phase) of the study. The efficacy and
safety of each regimen were assessed in both KRAS mutant and KRAS
wild-type recurrent LGSOC. The ongoing expansion Phase of the
trial, which is fully enrolled, will evaluate the efficacy and
safety of the regimen selected.
“Building on our breakthrough therapy designation, we are
pleased with the continued progress of our LGSOC program and look
forward to the presentation of these updated results from the RAMP
201 trial at ASCO 2023,” said Brian Stuglik, Chief Executive
Officer of Verastem Oncology. “LGSOC is a difficult disease to
treat and one in need of improved therapies to address this unique
ovarian cancer. We are working to bring forward what may be the
first therapy specifically approved for patients with LGSOC as
quickly as possible.”
The Company is in ongoing discussions with the U.S. Food and
Drug Administration (FDA) on confirmatory study plans and intends
to provide an update after agreement with the FDA. Continued
enrollment in the combination arm of RAMP 201 is planned to expand
the clinical experience in anticipation of initiation of a
confirmatory study.
Details for the ASCO 2023 Annual Meeting presentation are as
follows:
Title: Initial efficacy and safety results from
ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib
(VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer
(LGSOC). Lead author: Susana Banerjee, Institute of Cancer
Research and The Royal Marsden Abstract #: 5515
Session: Gynecologic Cancer Poster Session Display Date
and Time: 6/5/2023, 1:15 PM-4:15 PM Poster Discussion
Session Date and Time: 6/5/2023, 4:30 PM-6:00 PM Poster
Board Number: 210
About Low-Grade Serous Ovarian Cancer (LGSOC)
Low-grade serous ovarian cancer (LGSOC) is a highly recurrent,
chemotherapy-resistant cancer, associated with slow tumor growth
and high mortality rate. Approximately 6,000 women in the U.S. and
80,000 worldwide are living with this disease. Mutations in the
KRAS gene are present in 30% of cases of LGSOC. LGSOC is most often
diagnosed in women between the ages of 45-55 years and has a median
survival of approximately ten years. The majority of patients
experience severe pain and complications as the disease progresses.
Chemotherapy is the standard of care for this disease, with limited
treatment options currently available.
About Avutometinib (VS-6766)
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
pathway inhibition. Avutometinib is currently in late-stage
development.
In contrast to other 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- driven tumors as part of its
(Raf And Mek Program). RAMP 201 is a
registration-directed trial of avutometinib in combination with
defactinib in patients with recurrent LGSOC. 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. As part of the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, Verastem Oncology 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 and planned interactions with regulators
involving Verastem Oncology’s lead compound. 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 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 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 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; and that we will not pursue or submit regulatory
filings for our product candidates; 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 Verastem Oncology’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/20230426005206/en/
Investors: Dan Calkins +1 781-469-1694
dcalkins@verastem.com
Nate LiaBraaten +1 212-600-1902 nate@argotpartners.com
Media: Lisa Buffington +1 (781) 292-4205
lbuffington@verastem.com
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