Report Selection Phase (Part A) Results from
RAMP 201 and RAMP 202 Evaluating VS-6766 Alone and in Combination
with Defactinib in Low-Grade Serous Ovarian Cancer (LGSOC) and
KRAS-Mutant Non-Small Cell Lung Cancer (NSCLC), Respectively
Report Preliminary Data from Phase 1/2 Trial
Evaluating LUMAKRAS™ (sotorasib) and VS-6766 and Initiate Phase 1/2
Trial Evaluating adagrasib and VS-6766; Both in KRAS G12C-Mutant
Non-Small Cell Lung Cancer
Expand Ongoing Investigator-Initiated Trial
Program to Explore Combination Potential with VS-6766 in Additional
Areas of High Unmet Need; Data Read-Outs Expected Throughout
2022
Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company
committed to advancing new medicines for patients battling cancer,
today outlined key strategic priorities and upcoming catalysts to
support its lead compound VS-6766 in 2022. 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.
“Building on the Breakthrough Therapy designation for VS-6766
with defactinib in recurrent low-grade serous ovarian cancer, the
significant progress of our RAMP program in both low-grade serous
ovarian cancer and KRAS G12V-mutant non-small cell lung cancer, our
clinical collaborations in KRAS G12C-mutant non-small cell lung
cancer as well as our ongoing investigator-initiated trials
program, we expect to see tremendous progress on behalf of patients
in 2022,” said Brian Stuglik, CEO of Verastem Oncology. “We plan to
efficiently advance our development strategy, report multiple data
readouts and further highlight the differentiated potential of
VS-6766 across tumor types and mutations.”
2022 Strategic Priorities
Gynecologic Oncology Program
- Fully enroll Part B of the RAMP 201 trial (LGSOC VS-6766 +/-
defactinib).
- Expand development program into other RAS pathway-driven
gynecologic cancers.
Non-Small Cell Lung Cancer (NSCLC) Program
- Select regimen for Part B of the RAMP 202 trial (KRAS G12V
NSCLC VS-6766 +/- defactinib).
- Initiate and complete dose-finding portions of RAMP 203 (KRAS
G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) and RAMP 204 (KRAS
G12C NSCLC VS-6766 + adagrasib) combination trials.
- Provide signal read-out of investigator-sponsored trial of
VS-6766 and everolimus in KRAS- mutant NSCLC.
Other Programs
- Expand investigator-initiated trial program to include
signal-finding studies in other tumor types, including melanoma,
breast and colorectal cancers.
- Expand clinical combinations with VS-6766.
Anticipated 2022 Development Milestones and Catalysts
1Q-2022
- Having completed target enrollment (n=64) in the selection
phase (Part A) of the Phase 2 RAMP 201 trial (LGSOC VS-6766 +/-
defactinib), the enrollment phase (Part B) is now ongoing with both
treatment arms currently advancing.
- Complete enrollment in the selection phase (Part A) of the
Phase 2 RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/-
defactinib).
- Initiate RAMP 203 trial (KRAS G12C NSCLC VS-6766 + LUMAKRASTM
(sotorasib)) with Amgen.
Q2-2022
- Report topline results from Part A of the RAMP 201 trial (LGSOC
VS-6766 +/- defactinib), following discussions with regulatory
authorities.
- Initiate RAMP 204 trial (KRAS G12C VS-6766 + adagrasib) with
Mirati.
- Present topline results of investigator-initiated trial of
VS-6766 and everolimus in KRAS-mutant NSCLC.
- Present investigator-initiated FRAME LGSOC translational
data.
2H-2022
- Complete enrollment in the RAMP 201 trial (LGSOC VS-6766 +/-
defactinib).
- Report topline results from RAMP 202 trial (KRAS G12V NSCLC
VS-6766 +/- defactinib) and initiate the expansion phase (Part B),
following discussions with regulatory authorities.
- Report initial readout of the RAMP 203 trial (KRAS G12C NSCLC
VS-6766 + LUMAKRASTM (sotorasib)) with Amgen.
“We are pleased with the progress of our scientific
collaborations and the high level of interest of leading
investigators to advance the preclinical synergy data towards
clinical evaluation of VS-6766 in combinations across multiple
tumor types, including melanoma, colorectal and breast cancers,”
said Louis Denis, CMO of Verastem Oncology. “These clinical
research efforts complement our company-sponsored development
program and help to expediently advance our efforts to address an
even broader scope of significant unmet medical needs.”
About VS-6766
VS-6766 (formerly known as CH5126766 and RO5126766) 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 (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.1
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. Verastem Oncology has also
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.
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
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 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, 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 Verastem Oncology Press Release. Verastem Oncology Receives
Breakthrough Therapy Designation for VS-6766 with Defactinib in
Recurrent Low-Grade Serous Ovarian Cancer. May 24, 2021. Available
at:
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-receives-breakthrough-therapy-designation-vs.
Accessed October 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20220111005415/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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