Agenus Shows Unprecedented Activity for Botensilimab/Balstilimab Combination in Microsatellite Stable Colorectal Cancer at ESMO World GI Congress
29 Juni 2022 - 01:00PM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of therapeutics designed to activate the immune response
to cancers and infections, today announced expanded data from the
Phase 1b study of botensilimab (Fc-enhanced anti-CTLA-4) and
balstilimab (anti-PD-1) in patients with microsatellite stable
colorectal cancer (MSS CRC). The data demonstrate that the
combination offers strong durability and superior efficacy than
what has been reported in separate trials for standard of care and
other investigational therapies in 2L+ MSS CRC.
“These data reinforce the strong therapeutic potential of
botensilimab, when used in combination with balstilimab, in cold
tumors such as MSS CRC,” said Steven O’Day, MD, Chief Medical
Officer at Agenus. “Thus far, botensilimab has demonstrated
activity in nine cold and treatment-resistant cancers, and we plan
to initiate a robust, global Phase 2 program, including in MSS CRC,
later this year.”
Study Highlights
A total of 41 evaluable patients with metastatic MSS CRC
received either 1 or 2 mg/kg botensilimab Q6W, and 3 mg/kg
balstilimab Q2W. Patients were heavily pre-treated, with a median
of 4 prior lines of therapy, and 34% had received prior
immunotherapy. The botensilimab/balstilimab combination produced
superior responses and strong durability, relative to what has been
reported in separate trials for standard of care and other
combinations currently in development.
Objective responses:
- 24% overall response rate
- 73% disease control rate (partial
response + stable disease)
- 50% objective responses with greater
than 50% tumor reduction
Durability:
- 80% objective responses ongoing at
data cut-off
- 30% objective responses exceeding 1
year
Patient Sub-Populations:
- Objective responses in 5 patients
with RAS mutations for a 24% overall response rate and 81% disease
control rate in this population; other PD-1 combinations in
separate trials have reported only rare responses in this
population (≤1% response rate)
- Responses observed in patients with
metastases historically resistant to immunotherapy, including
patients with malignant pleural effusions, soft tissue, peritoneal,
retroperitoneal, and bone metastases
Tolerability:
- Botensilimab was well tolerated,
with no grade 4/5 treatment-related adverse events
- Rates of gastrointestinal and skin
toxicities were comparable to those reported with first-generation
CTLA-4 inhibitors
“Colorectal cancer is the second leading cause of cancer-related
death worldwide, with roughly 95% classified as microsatellite
stable and historically unresponsive to immunotherapy. Treatment
resistant MSS CRC patients lack effective options, with standard of
care offering only a 1-2% response rate and a median expected
survival ranging from 6 to 7 months,” said Anthony El-Khoueiry, MD,
Phase I Program Director at the USC Norris Comprehensive Cancer
Center, Keck Medicine of USC. “The combination of robust response
rate, durability, and tolerability demonstrated by botensilimab and
balstilimab supports further development of the combination in MSS
CRC, as well as more broadly, in other cold and treatment-resistant
tumors.”
Presentation Details
The data were presented today at 7:05 AM EDT in a late-breaking
oral presentation at the ESMO World Congress on Gastrointestinal
Cancer in Barcelona, Spain.
Abstract Title: Botensilimab, a Novel Innate/Adaptive Immune
Activator, Plus Balstilimab (Anti-PD-1) for Metastatic Heavily
Pretreated Microsatellite Stable Colorectal Cancer
Abstract Number: LBA-09
Presenting Author: Dr. Anthony El-Khoueiry, M.D., Associate
Director of Clinical Research at the USC Norris Comprehensive
Cancer Center, Keck School of Medicine
Investor Webcast
The Company will host an investor webcast today at 10:00 AM EDT
to review these data. Participants may register here, or on the
Investors section of the Agenus website at investor.agenusbio.com.
The webcast will include presentations by the below speakers and
will be followed by a Q&A session:
- Steven O’Day, M.D., Agenus’ Chief
Medical Officer
- Dr. Anthony El-Khoueiry, M.D.,
Associate Director of Clinical Research at the USC Norris
Comprehensive Cancer Center, Keck School of Medicine
- Dr. Manuel Hidalgo, Chief of the
Division of Hematology and Medical Oncology at Weill Cornell
Medicine/NewYork-Presbyterian Hospital, and
- Dr. Heinz-Josef Lenz, M.D.,
Professor of Medicine and J. Terrence Lanni Chair in
Gastrointestinal Cancer Research, Keck School of Medicine
Following the webcast, an archived version will be available on
the Agenus website.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body's
immune system to fight cancer and infections. The Company's vision
is to expand the patient populations benefiting from cancer
immunotherapy by pursuing combination approaches that leverage a
broad repertoire of antibody therapeutics, adoptive cell therapies
(through its subsidiary MiNK Therapeutics), and adjuvants (through
its subsidiary SaponiQx). The Company is equipped with a suite of
antibody discovery platforms and a state-of-the-art GMP
manufacturing facility with the capacity to support clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com and our Twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements relating to our technologies,
therapeutic candidates, and capabilities, for instance, statements
regarding therapeutic benefit and efficacy, mechanism of action,
potency, durability, and safety and tolerability profile of our
therapeutic candidates, both alone and in combination with each
other and/or other agents; statements regarding future plans,
including research, clinical, regulatory, and commercialization
plans; and any other statements containing the words "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"will" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially. These risks and uncertainties include, among
others, the factors described under the Risk Factors section of our
most recent Quarterly Report on Form 10-Q or Annual Report on Form
10-K filed with the Securities and Exchange Commission and
available on our website: www.agenusbio.com. Agenus cautions
investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only
as of the date of this press release, and Agenus undertakes no
obligation to update or revise the statements, other than to the
extent required by law. All forward-looking statements are
expressly qualified in their entirety by this cautionary
statement.
Contact
Ethan Lovell
Chief External Affairs & Communications Officer
339-927-1763
ethan.lovell@agenusbio.com
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