Agenus’ Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer
March 27 2023 - 9:45AM
Business Wire
Data presented at plenary session of Society
of Gynecologic Oncology Meeting
- Patients treated suffered from platinum resistant/refractory
ovarian cancer
- Previous PD-(L)1/CTLA-4 combinations have reported only
3-10% responses in comparable patient populations1,2
- Findings consistent with botensilimab/balstilimab benefit in
cold and refractory tumors across 9 different solid tumor
cancers
Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a
pipeline of immunological agents targeting cancer and infectious
disease, today announced results from a cohort of 24 evaluable
patients in an expansion of the Company’s Phase 1b study of
botensilimab (multifunctional CTLA-4 antibody) in combination with
balstilimab (PD-1 antibody) in patients with recurrent platinum
resistant/refractory ovarian cancer. These findings, presented in
an oral plenary session at the Society of Gynecologic Oncology
(SGO) 2023 Annual Meeting on Women’s Cancer, showed a 33% overall
response rate (ORR).
“These results add to the growing body of data showing deep and
durable efficacy signals for botensilimab across nine cold and
treatment-resistant cancers,” said Steven O’Day, M.D., Chief
Medical Officer of Agenus. “Botensilimab is designed with a unique
mechanism of action that stimulates both innate and adaptive immune
responses against cancer, resulting in an improved benefit compared
to what has been reported for other checkpoint therapies.“
“The combination of botensilimab and balstilimab in
platinum-resistant ovarian cancer shows promise for a substantial
improvement in efficacy compared to existing therapies, which
typically only yield single-digit response rates,” said Bruno
Bockorny, M.D., Harvard Medical School, Beth Israel Deaconess
Medical Center, and principal investigator for the study. “The
remarkable efficacy and manageable tolerability profile of this
combination suggest a transformative potential for ovarian cancer
patients.”
The ovarian cancer cohort is part of a large study evaluating
the safety, efficacy, and dose optimization of botensilimab alone
and in combination with balstilimab in multiple solid tumors.
Agenus is currently enrolling in Global Phase 2 ACTIVATE trial
programs in metastatic microsatellite stable colorectal cancer,
melanoma and pancreatic cancers. Based on recent positive findings
presented at SITC, Agenus is also expanding enrollment of its
anti-PD-(L)1 relapsed/refractory non-small cell lung cancer cohort
of the Phase 1b study and planning additional NSCLC studies.
Study Design and Highlights
A total of 24 evaluable patients with recurrent platinum
resistant/refractory ovarian cancer received either 1 or 2 mg/kg
botensilimab every 6 weeks and 3 mg/kg balstilimab every 2
weeks.
Patient Demographics
- 79% were high grade serous, which has a poor prognosis
- Patients were heavily pre-treated, with a median of 4 prior
lines of therapy including 21% with prior immunotherapy
- Majority of patients had biomarkers associated with poor
response to immunotherapy:
- 90% had a low tumor mutation burden (<10 mutations per
megabase)
- Over half of patients were PD-L1 negative by IHC
Clinical Findings
- 33% overall response rate (1 complete response, 7 partial
responses)
- Other PD-(L)1 + CTLA-4 combinations in other trials reported
3-10% response rates in a comparable patient population.1,2
- 67% disease control rate
- Median duration of response not reached
- Manageable tolerability profile
Presentation Details
Abstract Title: Botensilimab, a Novel Innate/Adaptive Immune
Activator, plus Balstilimab (Anti-PD-1) in Patients with Recurrent
Platinum Refractory/Resistant Ovarian Cancer (NCT03860272)
Presenting Author: Bruno Bockorny, MD, Harvard University, Beth
Israel Deaconess Medical Center
Data presented will be available to view in the Publications
section of the Agenus website (https://agenusbio.com/publications)
following the SGO Conference.
References
1 https://clinicaltrials.gov/ct2/show/results/NCT01928394 2
Hinchcliff et al. Gynecologic Oncology 2021
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational
antibody that has been designed to extend clinical benefits to
“cold” tumors that have not historically responded to standard of
care or investigational therapies. In addition to binding to the
CTLA-4 receptor, its Fc-enhanced structure induces a memory immune
response, downregulates regulatory T cells, and delivers better
priming and activation of T cells, thereby amplifying immune
responses.
In a Phase 1b clinical study of more than 300 patients,
botensilimab has demonstrated clinical responses in nine solid
tumor cancers, either alone or in combination with Agenus’ PD-1
antibody, balstilimab. Agenus is conducting global, randomized
Phase 2 trials in microsatellite-stable colorectal cancer (MSS
CRC), pancreatic cancer, and melanoma as part of its ACTIVATE trial
program. Additional information about these botensilimab trials can
be found at www.clinicaltrials.gov under the identifiers
NCT05608044, NCT05630183, and NCT05529316, respectively. A global
Phase 3 trial in MSS CRC is expected to launch in 2023.
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.
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MEDIA Susan Goldstein 646-217-8823
susan.goldstein@agenusbio.com
INVESTORS Zack Armen, Head of
Investor Relations 917-362-1370 zack.armen@agenusbio.com
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