Agenus Presents Clinical Data Demonstrating Durable Responses of Botensilimab/Balstilimab Combination in Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI
23 Januar 2023 - 01:30PM
Agenus (Nasdaq: AGEN), an immuno-oncology company with a pipeline
of immunological agents targeting cancer and infectious disease,
today announced clinical data from the MSS CRC (microsatellite
stable colorectal cancer) 70 patient cohort of a Phase 1b study of
botensilimab (multifunctional Fc-enhanced anti-CTLA-4) in
combination with balstilimab (anti-PD-1) in patients with
chemotherapy and/or immunotherapy-resistant tumors. The larger
dataset continues to demonstrate that this combination offers
superior efficacy and durability compared to what has been reported
for standard of care and other investigational therapies in third
line metastatic MSS CRC. The data were presented in the opening
late-breaking oral session at the American Society of Clinical
Oncology – Gastrointestinal Cancers Symposium (ASCO GI) in San
Francisco, CA on Saturday Jan 21 2023.
“This data highlight the deep and durable responses achieved
with botensilimab and balstilimab in advanced MSS CRC, underscoring
remarkable benefit for these patients who have failed standard of
care or other investigative therapies. With over 300 patients
enrolled to date, botensilimab alone and in combination with
balstilimab have demonstrated durable clinical responses across
nine cold and treatment-resistant cancers,” said Steven O’Day, MD,
Chief Medical Officer at Agenus. “Our top priority is to advance
this combination in global randomized trials with the intent to
bring this important treatment to patients expeditiously.”
“MSS CRC accounts for over 95% of metastatic CRC cases and is
characterized by tremendous unmet need, as available treatments
have reported single digit responses rates,” said Anthony
El-Khoueiry, MD, Phase I Program Director and Associate Director
for Clinical Research at the USC Norris Comprehensive Cancer
Center, Keck Medicine of USC, and the Principal Investigator for
the study. “The 23% response rate demonstrated by botensilimab plus
balstilimab in this study supports rapid development of this
combination in MSS CRC.”
Study Design and Highlights:
A total of 70 evaluable patients with refractory metastatic MSS
CRC received either 1 or 2 mg/kg botensilimab every 6 weeks and 3
mg/kg balstilimab every 2 weeks.
Patient Demographics:
- Heavily pre-treated, with a median
of 4 prior lines of therapy
- 31% had received prior
immunotherapy
Objective responses:
- 23% overall response rate
- Other PD-(L)1 + CTLA-4 combinations
in comparable patient populations have reported 1-5% response
rates1,2
- 69% of objective responses were
ongoing at data cut-off
- 76% disease control rate (complete
response + partial response + stable disease)
Survival:
- 12-month overall survival of 63%
- Reported 12-month overall survival
for standard of care is ~25%
- Median overall survival has not been
reached
Tolerability:
- Manageable gastrointestinal toxicity
with a differentiated overall safety profile
Presentation Details:
Abstract Title: Results from a phase 1a/1b
study of botensilimab (BOT), a novel innate/adaptive immune
activator, plus balstilimab (BAL; anti-PD-1 antibody) in metastatic
heavily pretreated microsatellite stable colorectal cancer (MSS
CRC) (NCT03860272)
Abstract Number: LBA8
Presenting Author: Anthony El-Khoueiry, MD,
Phase I Program Director at the USC Norris Comprehensive Cancer
Center, Keck Medicine of USC
Following the symposium, an archived version of the presentation
will be available in the Publications section of the Agenus website
at www.agenusbio.com.
References
1 Chen et al. JAMA Oncol. 2020
2 Overman et al. ASCO 2016
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
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therapeutic candidates, and capabilities, for instance, statements
regarding therapeutic benefit and efficacy, mechanism of action,
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our website: www.agenusbio.com. Agenus cautions investors not to
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contained in this release. These statements speak only as of the
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Contact
Agenus Inc.Zack ArmenInvestor Relations(917)
362-1370 Zack.Armen@agenusbio.com
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