Interim Analysis Findings Support Continued
Evaluation of Both Monotherapy and Combination Therapy
Encouraging Efficacy Results Include
Independently Confirmed Responses in Both KRAS Mutant and KRAS
Wild-Type Tumors with No New Safety Signals Observed
Substantial Majority (~80%) of Patients Remain
on Therapy; Timing of Go Forward Treatment Regimen Selection Driven
by Data Maturity
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for people living with cancer,
today announced an update from an interim analysis of its
international Phase 2 RAMP 201 trial evaluating VS-6766 ±
defactinib in recurrent low-grade serous ovarian cancer (LGSOC),
regardless of KRAS status.
Verastem recently completed a planned interim analysis of its
RAMP 201 trial with the goal of selecting a go forward treatment
regimen of either VS-6766 monotherapy or VS-6766 in combination
with defactinib. The analysis indicated encouraging efficacy
results with confirmed responses by independent review in patients
treated with VS-6766 monotherapy and patients treated with VS-6766
in combination with defactinib. The findings also include confirmed
responses by independent review in both KRAS mutant and KRAS
wild-type LGSOC. To date, there have been no additional safety
signals with a continued favorable safety profile in both the
monotherapy and combination treatment arms with approximately 6% of
patients discontinuing due to adverse events.
With a substantial majority (approximately 80%) of patients
remaining on study treatment with a median duration of follow-up of
four months, the Company has concluded that the data from the
interim analysis are not mature enough to make a final decision on
the go forward treatment regimen at this time and the trial will
continue with all four cohorts (VS-6766 ± defactinib in KRAS mutant
and KRAS wild type patient populations).
“We are encouraged by the positive anti-tumor activity that we
have seen to date in the RAMP 201 trial in patients with both KRAS
mutant and KRAS wild-type tumors. We look forward to evaluating a
more mature data set and expect to provide an update on progress
once the go forward treatment regimen has been determined,” said
Brian Stuglik, Chief Executive Officer, Verastem Oncology. “This
interim analysis adds to our optimism about the potential for
VS-6766 with or without defactinib and our commitment to advancing
the first new treatment specifically developed and approved for
women with low-grade serous ovarian cancer where a high medical
need remains.”
The Company plans to complete enrollment of all four cohorts of
the trial in the second half of this year. Each cohort is expected
to have approximately 36 patients for a total of 144 patients.
Both VS-6766 and defactinib are in late-stage development and
the combination has received Breakthrough Therapy Designation by
the U.S. Food and Drug Administration for the treatment of all
patients with recurrent low-grade serous ovarian cancer regardless
of KRAS status after one or more prior lines of therapy, including
platinum-based chemotherapy.
About the VS-6766/Defactinib Combination
VS-6766 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. In contrast to currently available MEK inhibitors,
VS-6766 blocks both MEK kinase activity and the ability of RAF to
phosphorylate MEK. This unique mechanism allows VS-6766 to block
MEK signaling without the compensatory activation of MEK that
appears to limit the efficacy of other inhibitors. The combination
of VS-6766 and FAK inhibitor, defactinib provides RAF/MEK vertical
blockade and FAK parallel inhibition to overcome key resistance
mechanisms. Both VS-6766 and defactinib are in late-stage
development.
Verastem Oncology is conducting Phase 2 registration-directed
trials of VS-6766 alone and 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) clinical trials, RAMP 201 and RAMP 202,
respectively (www.ramp201study.com and www.ramp202study.com).
Verastem Oncology has also established clinical collaborations with
Amgen, Inc. and Mirati Therapeutics, Inc. to evaluate LUMAKRAS™
(sotorasib) and adagrasib in combination with VS-6766 in KRAS
G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials,
respectively.
About Low-Grade Serous Ovarian Cancer
Low-grade serous ovarian cancer is a highly recurrent,
chemotherapy-resistant cancer, associated with slow tumor growth
and high mortality rate.1 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 35-57% cases of LGSOC.2 LGSOC is most
often diagnosed in women between the ages of 45-55 years and has a
median survival of approximately ten years.2 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.2
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 timing of commencing and completing
trials, including topline data reports, and potential for
additional development programs involving Verastem Oncology’s lead
compounds VS-6766 and defactinib. 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 VS-6766 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 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 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 VS-6766 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, 2021 as filed with the Securities
and Exchange Commission (SEC) on March 28, 2022 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.
References:
1 Grisham R. Low grade serous carcinoma of the ovary. Oncology.
2016; 30(7):650-652. Available at:
https://www.cancernetwork.com/view/low-grade-serous-carcinoma-ovary.
Accessed February 8, 2022
2 Slomovitz B, Gourley C, Carey S. M, Malpica A, Shih I,
Huntsman D, et al. Low-Grade serous ovarian cancer: State of the
Science. Gynecol Oncol. 2020;156(3):715-725.
https://doi.org/10.1016/j.ygyno.2019.12.033.
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version on businesswire.com: https://www.businesswire.com/news/home/20220606005303/en/
Investors: Ajay Munshi Vice President, Corporate
Development +1 781-469-1579 amunshi@verastem.com
Nate LiaBraaten Argot Partners +1 212-600-1902
nate@argotpartners.com
Media: Lisa Buffington Corporate Communications +1
781-292-4205 lbuffington@verastem.com
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