Verastem Oncology Announces Updated Phase 1/2 FRAME Study Data in Low Grade Serous Ovarian Cancer Selected for a Mini Oral Presentation at the European Society of Medical Oncology Congress 2021
July 27 2021 - 7:00AM
Business Wire
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients battling cancer,
today announced that an abstract detailing updated results from the
ongoing Phase 1/2 FRAME study investigating VS-6766, the Company’s
RAF/MEK inhibitor, in combination with defactinib, its FAK
inhibitor, in patients with low grade serous ovarian cancer (LGSOC)
has been selected for a mini oral presentation at the upcoming
European Society of Medical Oncology (ESMO) Congress 2021, taking
place virtually September 16-21, 2021.
“The investigator-sponsored FRAME study has been instrumental in
providing the foundational knowledge regarding the safety, efficacy
and durability of the VS-6766/defactinib combination as well as the
basis for the breakthrough therapy designation recently granted by
the FDA. We are pleased this abstract has been selected for a mini
oral presentation at ESMO 2021, and we look forward to further
engaging with the medical community regarding these important
data,” said Jonathan Pachter, Ph.D., Chief Scientific Officer of
Verastem Oncology. “Patients with low-grade serous ovarian cancer
urgently need better solutions due to low response rates and
tolerability issues associated with other therapeutic approaches.
The company-sponsored, registration-directed Phase 2 RAMP 201 study
is well underway, with top-line results from the selection phase
expected during the first half of 2022.”
Verastem Oncology is currently evaluating the efficacy and
safety of VS-6766 alone and in combination with defactinib in the
registration-directed Phase 2 RAMP 201 (Raf And
Mek Program) (ENGOTov60/GOG3052) trial in patients
with recurrent LGSOC.1
Details for the ESMO 2021 mini oral presentation are as
follows:
Title: Phase I study of the combination of the dual
RAF/MEK inhibitor VS-6766 and the FAK inhibitor defactinib: Results
of efficacy in low grade serous ovarian cancer Speaker:
Susana Banerjee, Royal Marsden NHS Foundation Trust Presentation
#: 725MO Session: Mini oral – Gynaecological cancers
Date and Time: Sunday, September 19, 2021; 17:50-17:55
CEST
About the VS-6766/Defactinib Combination
The combination of VS-6766 and defactinib has been found to be
clinically active in patients with KRAS mutant tumors. In an
ongoing investigator-initiated Phase 1/2 FRAME study, the
combination of VS-6766 and defactinib is being evaluated in
patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC).
The FRAME study was expanded to include new cohorts in pancreatic
cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC.
Verastem Oncology is also supporting an investigator-initiated
Phase 2 trial evaluating VS-6766 with defactinib in patients with
metastatic uveal melanoma. Verastem Oncology has initiated Phase 2
registration-directed trials of VS-6766 with defactinib in patients
with recurrent LGSOC and in patients with recurrent KRAS-G12V
mutant NSCLC as part of its RAMP (Raf And Mek
Program).
The U.S. Food and Drug Administration (FDA) granted Breakthrough
Therapy designation for the combination of Verastem Oncology’s
investigational RAF/MEK inhibitor VS-6766, 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.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) (Verastem, Inc.) 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 the
RAF/MEK/FAK combination, the potential benefits of Breakthrough
Therapy designation and the timing of commencing and completing
registration-directed trials for the RAF/MEK/FAK combination. 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 defactinib in combination with VS-6766; 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 labeling and other matters that
could affect the 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; that we or Chugai Pharmaceutical Co., Ltd. will fail to
fully perform under the VS-6766 license agreement; 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 we will be unable to
execute on our partnering strategies for defactinib in combination
with VS-6766; that we will not pursue or submit regulatory filings
for our product candidates; that we do not receive additional
proceeds from the contingent payments negotiated in the sale of
COPIKTRA; 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, 2020 as filed with the Securities
and Exchange Commission (SEC) on March 18, 2021 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.
___________________________________
1 Clinicaltrials.gov. A Study of VS-6766 v. VS-6766 + Defactinib
in Recurrent Low-Grade Serous Ovarian Cancer With and Without a
KRAS Mutation. Available at:
https://clinicaltrials.gov/ct2/show/NCT04625270?cond=vs6766&draw=2&rank=1.
Accessed April 9, 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20210727005317/en/
Investors: Ajay Munshi Vice President, Corporate
Development +1 781-469-1579 amunshi@verastem.com
Sherri Spear Argot Partners +1 212-600-1902
sherri@argotpartners.com
Media: Lisa Buffington Corporate Communications +1
781-292-4205 lbuffington@verastem.com
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