Agenus Data at CTOS 2022 Highlight Durable Clinical Responses of Botensilimab / Balstilimab Combination in Advanced Sarcoma
November 17 2022 - 7:30AM
Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad
pipeline targeting cancer and infectious disease, announced
expanded data from the Company’s Phase 1 study of botensilimab
(Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients
with advanced sarcoma. The data demonstrate that the combination
offers strong durability and superior efficacy compared to what has
been reported in separate trials for standard of care and other
investigational therapies in sarcoma, including in sarcoma subtypes
historically unresponsive to immunotherapy. The results will be
presented tomorrow in an oral presentation at the Connective Tissue
Oncology Society (CTOS) 2022 Annual Meeting in Vancouver, BC,
Canada.
“The superior efficacy and durable responses achieved with
botensilimab and balstilimab in advanced sarcoma build on the
unprecedented clinical responses we have observed with this
combination in multiple cold, treatment-resistant cancers,” said
Steven O’Day, MD, Chief Medical Officer at Agenus. “We are
advancing multiple randomized Phase 2 trials to evaluate the
therapeutic potential of this agent across a range of solid
tumors.”
Study Design and Highlights:
A total of 13 evaluable patients with advanced sarcoma 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 3 prior lines of therapy
- 31% had received prior
immunotherapy
- 82% had a known tumor mutation
burden of less than 10 mutations per megabase
- Majority were PD-L1 negative by
IHC
All of these biomarkers are associated with poor response to
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:
- 46% overall response rate
- Other PD-(L)1 + CTLA-4 combinations
in a comparable patient population achieved only 12-16% response
rates1,2
- 69% disease control rate (complete
response + partial response + stable disease)
Durability:
- 67% objective responses ongoing at
data cut-off
- Median duration of response has not
been reached
Survival:
- 12-month overall survival of
77%
- Median overall survival has not been
reached
Patient Sub-Populations:
- Objective response rate of 56% and
disease control rate of 78% in 9 patients with angiosarcoma,
including 3 of 4 patients with visceral angiosarcoma
- Other PD-(L)1 + CTLA-4 combinations
achieved only 20-25% response rates in patients with angiosarcoma,
with no reported responses in 7 patients with visceral
angiosarcoma2,3
- Responses observed in additional
patients with sarcoma subtypes historically resistant to
immunotherapy, including liposarcoma with leiomyosarcomatous
differentiation
Tolerability:
- Botensilimab was well tolerated; no
grade 4 or 5 treatment-related adverse events in this cohort
- Safety profile similar to what has
been previously reported in the Phase 1 botensilimab program, with
no new immune-mediated safety signals observed
“At present, available treatments for advanced soft tissue
sarcoma patients only have modest activity, and response rates for
other immunotherapy combinations for most types of sarcoma are well
below 20 percent,” said Breelyn Wilky, MD, Principal Investigator
and Director of Sarcoma Medical Oncology at the University of
Colorado School of Medicine. “The clinical responses demonstrated
by botensilimab and balstilimab in this study are compelling and
support plans for further development of this combination in
sarcoma.”
Presentation Details:
Abstract Number: 1294633
Abstract Title: Results from a Phase 1a/1b Study of Botensilimab
(a Novel CTLA-4 Engager) Plus Balstilimab (Anti-PD-1 Antibody) for
the Treatment of Patients with Advanced Sarcomas
Presenting Author: Breelyn A. Wilky, MD, Director of Sarcoma
Medical Oncology, Deputy Associate Director for Clinical Research,
University of Colorado Cancer Center
The data will be presented on November 18th at 4:15 PM PDT in an
oral presentation at the Connective Tissue Oncology Society (CTOS)
2022 Annual Meeting in Vancouver, BC, Canada. An archived version
of the presentation will be available on the Agenus website at
agenusbio.com.
References1 D’Angelo et al. Lancet Oncology
20182 Somaiah et al. Lancet Oncology 20223 Wagner et al JITC
2021
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.
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made pursuant to the safe harbor provisions of the federal
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therapeutic candidates, and capabilities, for instance, statements
regarding therapeutic benefit and efficacy, mechanism of action,
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candidates, both alone and in combination with each other and/or
other agents; statements regarding future plans, including
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Contact
Agenus Inc.Nico FrelickInvestor
Relations781-674-4616nico.frelick@agenusbio.com
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