Verastem Presents Avutometinib and Defactinib Combination Program Updates at the 5th Annual RAS-Targeted Drug Development Summit
29 9월 2023 - 3:15AM
Business Wire
Preclinical and Clinical Presentations Include
Update on FRAME Study Low-Grade Serous Ovarian Cancer Efficacy
Data
Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced the presentation of scientific background and
clinical trial updates on the avutometinib and defactinib programs
at the 5th Annual RAS-Targeted Drug Development Summit in Boston,
Massachusetts. The updates are part of two oral presentations by
Jonathan Pachter, PhD, Chief Scientific Officer and Louis Denis,
MD, Chief Medical Officer at Verastem Oncology. The first
presentation titled “Vertical Inhibition of RAS, RAF & MEK:
Enhancing Antitumor Efficacy of KRAS G12C & G12D Inhibitors
with RAF/MEK Clamp Avutometinib”, includes scientific rationale for
clinical combinations with avutometinib and defactinib in various
RAS pathway-driven cancers. The second presentation titled,
“Introducing Rational Combinations of RAF/MEK Clamp Avutometinib:
Breakthrough Therapy Designation & Beyond,” discusses novel
combination treatment approaches and provides an overview of the
avutometinib and defactinib clinical development program.
The clinical presentation includes updated FRAME study efficacy
data showing an overall response rate (ORR) of 42% (11 of 26) in
evaluable patients with low grade serous ovarian cancer (LGSOC)
(n=26). Among patients with KRAS mutant LGSOC (n=12), the ORR was
58% (7 of 12), compared to patients with KRAS wild-type LGSOC
(n=12), the ORR was 33% (4 of 12). Across all LGSOC patients, the
median duration of response was 26.9 months (95% CI: 8.5-47.3)
while median progression free survival (PFS) was 20.0 months (95%
CI: 11.1-31.2). As of the July 2023 data cutoff date, 19% of
patients (5 of 26) were still on study treatment with a minimum
follow-up of 17 months.
“We are encouraged that the high rate and long duration of
objective responses in the recurrent LGSOC cohort of the FRAME
study continue to provide foundational proof-of-concept supporting
Breakthrough Therapy Designation for the combination of
avutometinib and defactinib,” said Dan Paterson, President and
Chief Executive Officer of Verastem Oncology.
The FRAME study, led by Professor Udai Banerji, MBBS, MD, DNB,
PhD, FRCP, Deputy Director of the Drug Development Unit at The
Institute of Cancer Research, London, and The Royal Marsden NHS
Foundation Trust, is an ongoing investigator-sponsored trial
evaluating avutometinib in combination with defactinib among
patients with advanced solid tumors, including recurrent LGSOC. The
Company recently reported results of Part A of RAMP 201 in
recurrent LGSOC including confirmed ORR by blinded independent
central review of 45% (13/29; 95% CI: 26%,64%) with a tolerable
safety profile at the American Society of Clinical Oncology (ASCO)
2023 Annual Meeting. The median duration of response and median PFS
from RAMP 201 Part A were not yet reached at the time of the ASCO
2023 presentation.
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.
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
pathway inhibition. In contrast to currently available MEK
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
inhibitors. The U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK clamp avutometinib, 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 avutometinib in RAS pathway-driven tumors as part
of its (Raf And Mek Program). RAMP 301
is a planned 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 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 and RAMP 204 trials, respectively. Supported by the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical
trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
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Investors: Dan Calkins Investor Relations +1 781-469-1694
dcalkins@verastem.com
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Media: Lisa Buffington Corporate Communications +1 (781)
292-4502 lbuffington@verastem.com
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