FDA Meeting Planned for Q4 to Discuss
Regulatory Path Forward Based on Encouraging Results to Date in
Ongoing RAMP 201 Trial in LGSOC
Results of Part A of RAMP 202 Trial in KRAS
G12V-Mutant NSCLC Show VS-6766 ± Defactinib Did Not Meet Criteria
to Continue to Expansion Phase
RAMP Trials with VS-6766 Combinations in KRAS
G12C-Mutant NSCLC and Frontline Metastatic Pancreatic Cancer on
Track
Newly Issued Patents Extend Coverage of VS-6766
and VS-6766 + Defactinib to 2038 and 2040
Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced an update on its RAMP (Raf And
Mek Program) clinical trials.
RAMP 201 in Patients with Recurrent Low Grade Serous Ovarian
Cancer (LGSOC)
Verastem recently conducted a second planned interim analysis of
the ongoing RAMP 201 trial among patients with recurrent LGSOC.
Based on the results, including independently confirmed responses
and no new safety signals, the Company is planning to meet with the
U.S. Food and Drug Administration (FDA) in the fourth quarter to
review the data set, discuss the go forward treatment regimen
selection and align on a regulatory path forward.
“We are pleased with the encouraging results to date from our
RAMP 201 trial in patients with recurrent low-grade serous ovarian
cancer as we continue to see independently confirmed response
rates, no new safety signals and a majority of patients still on
treatment,” said Brian Stuglik, Chief Executive Officer of Verastem
Oncology. “As part of our Breakthrough Therapy Designation status
and ongoing communications with the FDA, we look forward to our
upcoming meeting to align on a regulatory path forward to advance
this potential option for patients with LGSOC, who have a high
unmet need and no approved therapies to treat their disease.”
Since the first interim analysis announced in June, the trial
has been continuing with all four cohorts (VS-6766 ± defactinib in
KRAS mutant and KRAS wild type patient populations) with full
enrollment based on the study protocol expected by the end of the
year. Interim results will not be released at this time to ensure
the integrity of this ongoing, registration-directed clinical
trial.The Company will provide an update after the upcoming meeting
with the FDA.
RAMP 202 in Patients with KRAS G12V-Mutant Non-Small Cell
Lung Cancer
In a planned analysis of the Part A data from the RAMP 202 trial
among patients with KRAS G12V NSCLC treated with the combination of
VS-6766 and defactinib (n=19), the confirmed overall response rate
(ORR) by independent review was 11% (2 of 19) with a disease
control rate of 37%. The ORR with non-G12V KRAS mutations was 5% (2
of 37) (one confirmed and one unconfirmed by independent review)
with a disease control rate of 54%, and no subtype was identified
for further clinical evaluation of VS-6766 with defactinib in this
trial. Verastem plans to present the Part A results of RAMP 202 at
an upcoming medical congress.
“While this combination of VS-6766 and defactinib did not meet
the pre-defined criteria to continue in the RAMP 202 trial, we
remain optimistic about other combinations with VS-6766 in NSCLC,”
said Brian Stuglik, Chief Executive Officer of Verastem Oncology.
“We will continue to analyze the results of the trial and include
the findings in our development plans moving forward as we evaluate
additional combinations for VS-6766 to best maximize its potential
benefit.”
RAMP 203 and RAMP 204 in Patients with KRAS G12C-Mutant
NSCLC
The RAMP 203 Phase 1/2 trial to evaluate the safety,
tolerability and efficacy of VS-6766 in combination with Amgen’s
KRAS G12C inhibitor LUMAKRASTM (sotorasib) in patients with KRAS
G12C-mutant NSCLC, has advanced to the Cohort 2 of 4mg VS-6766 in
combination with 960mg of LUMAKRASTM. Initial results are expected
by the fourth quarter of this year. The RAMP 204 Phase 1/2 trial of
VS-6766 and Mirati’s adagrasib, which will determine the maximum
tolerated dose and recommended Phase 2 dose for the combination and
evaluate the safety, tolerability and efficacy of the combination
in patients who have progressed on a KRAS G12C inhibitor, is open
and enrolling.
These studies will investigate the potential benefits of a more
complete vertical blockade of the RAS pathway as acquired
resistance to KRAS G12C inhibitors in patients occurs predominantly
through additional mutations in the RAS pathway, many of which
could be addressed with a downstream inhibitor such as VS-6766.
RAMP 205 in Patients with Frontline Metastatic Pancreatic
Cancer
The Company plans to open the RAMP 205 Phase 1b/2 clinical trial
of VS-6766 with defactinib in addition to standard of care
chemotherapy (gemcitabine/nab-paclitaxel regimen) in frontline
metastatic pancreatic cancer in the fourth quarter of this year.
The trial, in partnership with the Pancreatic Cancer Action Network
(PanCAN) will evaluate whether a more complete blockade of KRAS
signaling, which is mutated in more than 90% of pancreatic cancer
tumors, will improve outcomes for patients with pancreatic
cancer.
Corporate Updates
Intermittent dosing intellectual property for both VS-6766 alone
(previously announced) and in combination with defactinib was
recently allowed, extending patent coverage up to 2038 and 2040,
respectively.
As of August 31, 2022, Verastem Oncology had cash, cash
equivalents and investments of $110.4 million.
About VS-6766
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. VS-6766 is currently in late-stage development.
In contrast to other 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 U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK clamp 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.
Verastem Oncology is currently conducting clinical trials with
its RAF/MEK clamp in RAS-driven tumors as part of its (Raf
And Mek Program). RAMP 201 is a
registration-directed trial of VS-6766 alone and in combination
with defactinib in patients with recurrent LGSOC. Verastem Oncology
has established clinical collaborations with Amgen and Mirati 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. As part of the “Therapeutic Accelerator
Award” Verastem Oncology received from the Pancreatic Cancer
Network (PanCAN), the Company is conducting RAMP 205, a Phase 1b/2
clinical trial evaluating VS-6766 and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
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 cash runway, the potential clinical value of
various of its clinical trials, the timing of commencing and
completing trials, including data reports, 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 VS-6766 in combination with other compounds,
including defactinib, LUMAKRASTM 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221004005480/en/
Investors: Dan Calkins +1 781-469-1694 Investor Relations
dcalkins@verastem.com Nate LiaBraaten +1 212-600-1902
nate@argotpartners.com Media: Lisa Buffington Corporate
Communications +1 781-292-4205 lbuffington@verastem.com
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