Late-breaking oral presentation of a subgroup
analysis in RAMP 201 Part A heavily pretreated patients receiving
avutometinib and defactinib and their best response compared to
most recent prior therapy
Plenary oral presentation of preclinical
efficacy of the combination of avutometinib and FAK inhibitor in a
patient-derived model of low-grade serous ovarian cancer
A trials-in-progress poster presentation
outlining the details of the ongoing Phase 3 RAMP 301 trial
evaluating avutometinib and defactinib in low-grade serous ovarian
cancer
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced multiple oral and poster presentations, including a
late-breaking oral presentation of avutometinib and defactinib
combination from the RAMP 201 Part A trial in heavily pretreated
patients with low-grade serous ovarian cancer (LGSOC), at the
Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on
Women’s Cancer, to be held on March 16-18 in San Diego, California.
Verastem will have an exhibition booth (#420) at the meeting to
provide an overview of its ongoing cancer research.
“Important subgroup analyses from Part A of the Phase 2 RAMP 201
clinical trial evaluating avutometinib and defactinib demonstrate
how our research in low-grade serous ovarian cancer continues to
elucidate the potential use of this combination in a heavily
pretreated patient population, including patients who received a
prior MEK-only inhibitor,” said Dan Paterson, president and chief
executive officer of Verastem Oncology. “In addition, the plenary
oral presentation highlighting preclinical efficacy of avutometinib
in combination with a FAK inhibitor reinforces the potential of
this combination in low-grade serous ovarian cancer regardless of
KRAS status. Furthermore, the oral presentation from the LGSOC
Patient Impact Survey, that is supported by Verastem Oncology,
highlights the negative social and emotional impact patients
experience living with this rare ovarian cancer.”
Key Data Presentations:
Late-Breaking Oral Presentation
- Title: Avutometinib plus defactinib in recurrent,
low-grade serous ovarian cancer: A subgroup analysis of
ENGOT-ov60/GOG-3052/RAMP 201 Part A
- Session: Scientific Plenary IV: Late Breaking Abstract
Session 1
- Date/Time: Sunday, March 17, 2024, 4:15 – 5:30 p.m.
PDT
- Presenter: Dr. Susanna Banerjee, BBS, MA, PhD, FRCP
Focused Plenary Oral Presentation
- Title: Preclinical efficacy of RAF/MEK clamp
avutometinib in combination with FAK inhibition for low grade
serous ovarian cancer
- Session: Focused Plenary V: Rare Cancer: Updates in
Uncommon Cancers
- Date/Time: Sunday, March 17, 2024, 1:45 – 2:45 p.m.
PDT
- Presenter: Michelle Greenman, MD, MPH
Oral Poster Presentation
- Title: Voices of women with low-grade serous ovarian
cancer: Results from a multinational survey
- Session: Poster Session II
- Date/Time: Monday, March 18, 2024, 11:45 a.m. – 12:45
p.m. PDT
- Presenter: Charlotte C. Sun, DrPH, MPH
Trials in Progress Poster Presentation
- Title: A phase III, randomized trial evaluating
avutometinib plus defactinib compared with investigator's choice of
therapy in patients with recurrent low-grade serous ovarian cancer:
GOG-3097/ENGOT-ov81/NCRI/RAMP 301
- Session: Poster Session II
- Date/Time: Monday, March 18, 2024, 11:45 a.m. – 12:45
p.m. PDT
- Presenter: Rachel N. Grisham, MD
Drs. Banerjee and Grisham are paid consultants for Verastem
Oncology. The multinational survey is supported by 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-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. The U.S. Food and Drug Administration (FDA)
granted Breakthrough Therapy designation for the combination of
Verastem Oncology’s investigational RAF/MEK clamp avutometinib,
with defactinib, a selective FAK inhibitor, for the treatment of
all patients with recurrent LGSOC regardless of KRAS status 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 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
(NCT06072781) 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 (NCT04625270) 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 (NCT05074810) and RAMP 204
(NCT05375994) trials, respectively. Supported by the “Therapeutic
Accelerator Award” Verastem Oncology received from PanCAN, Verastem
Oncology is conducting 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.
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 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 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 its various
clinical trials, the timing of commencing and completing trials,
including topline data reports, interactions with regulators, the
potential for and timing of commercialization of product candidates
and potential for additional development programs 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
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 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 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 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; that we may not have sufficient cash to fund
our contemplated operations; 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 our target market for our product candidates might
be smaller than we are presently estimating; that Secura Bio, Inc.
will fail to fully perform under the asset purchase agreement with
Secura Bio, Inc., 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, 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 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/20240311346009/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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