ESMO 2023: Agenus’ Botensilimab/Balstilimab Combination Delivers Durable Responses across Multiple Sarcoma Subtypes
21 Ottobre 2023 - 10:15AM
Business Wire
Agenus Inc. (Nasdaq:AGEN), a leader in developing novel
immunological agents to treat various cancers, today announced
expanded data from the company’s phase 1b study of botensilimab
(BOT, multifunctional immune activator) in combination with
balstilimab (BAL, anti-PD-1) in patients with advanced sarcomas.
The results were presented in an oral presentation at the European
Society for Medical Oncology (ESMO) Congress 2023.
Relapsed/refractory sarcoma represents a significant unmet
medical need where existing standard of care options and previous
immunotherapies have shown limited activity. At present, available
treatments for advanced soft tissue sarcoma patients only have
modest activity. The sarcoma cohort presented is part of a larger
phase 1b study evaluating the safety, efficacy, and dose
optimization of BOT alone and in combination with BAL in multiple
advanced solid tumors.
"These results reinforce the promising potential of BOT+BAL in
multiple cold, treatment-resistant solid tumors," said Dr. Steven
O’Day, Chief Medical Officer. "Notably, we observed several durable
responses extending past one year, including patients with visceral
angiosarcoma, which is traditionally unresponsive to immunotherapy,
as well as other cold subtypes like leiomyosarcoma. As we expand
the study, we aim to focus on key subsets and dosing strategies to
maximize benefit for patients.”
“As the study has advanced, BOT+BAL continues to demonstrate
encouraging results in a larger population of patients with
difficult to treat sarcomas, with a median response duration of
19.4 months and a 40% 6-month progression-free survival rate. We're
also seeing a dose-dependent effect, with a 29% objective response
rate at 2 mg/kg,” said Dr. Breelyn Wilky, MD, Director of Sarcoma
Medical Oncology at the University of Colorado, and study
investigator.
Study Design and
Highlights
A total of 41 evaluable patients received either 1 or 2 mg/kg
BOT every 6 weeks and 3 mg/kg BAL every 2 weeks.
Patient Demographics
- Majority of patients had either angiosarcoma (29%) or
leiomyosarcoma (39%) subtypes
- Patients were heavily pre-treated, with a median of three prior
lines of therapy, including 16% who received prior PD-(L)1
therapy
- Majority of patients had biomarkers associated with poor
response to immunotherapy:
- 87% had a low tumor mutation burden (<10 mutations per
megabase)
- 74% of patients were PD-L1 negative by
immunohistochemistry
Clinical Findings
Efficacy in all comers (as measured by iRECIST; n=41)
- 40% 6-month PFS
- 20% ORR
- 29% ORR at the BOT 2 mg/kg dose level
- 15% ORR at the 1 mg/kg dose level
- 63% disease control rate (best response of a complete response
+ partial response + stable disease)
- Median duration of response was 19.4 months
Safety in all comers (N=50)
- No new safety signals reported, with tolerability consistent
across tumor types
- Adverse events were generally manageable and reversible
- Diarrhea/colitis was the most clinically significant
immune-mediated adverse event
- No grade 4 or 5 treatment-related adverse events and no related
cases of irreversible events such as hypophysitis, pneumonitis,
hepatitis, or myocarditis were reported
Presentation Details
Abstract Title: Efficacy and safety of botensilimab (BOT)
plus balstilimab (BAL) in patients (pts) with refractory metastatic
sarcoma (NCT03860272) Abstract Number: 1919MO Presenting
Author: Breelyn A. Wilky, MD, Director of Sarcoma Medical
Oncology, Deputy Associate Director for Clinical Research,
University of Colorado Cancer Center Session Date and Time:
10/21/2023, 10:15 a.m. – 11:45 a.m. CEST Presentation Date and
Time: 10/21/2023, 11:00 a.m. – 11:05 a.m. CEST
The presentation is available on the Agenus website at
https://agenusbio.com/publications
References
1 . D’Angelo SP, et al. Lancet Oncol. 2018;19 2. Chen JL, et al.
J Clin Oncol. 2020;38(15)_suppl:11511-11511 3. Wagner MJ, et al. J
Immunother Cancer. 2021;9:e002990.
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4
immune activator designed to boost both innate and adaptive
anti-tumor immune responses. Its novel design leverages mechanisms
of action to extend immunotherapy benefits to "cold" tumors which
generally respond poorly to standard of care or are refractory to
conventional PD-1/CTLA-4 therapies and other investigational
therapies. Botensilimab augments immune responses across a wide
range of tumor types by priming and activating T cells,
downregulating intratumoral regulatory T cells, activating myeloid
cells and inducing long-term memory responses.
Approximately 600 patients have been treated with botensilimab
in phase 1 and phase 2 clinical trials. Botensilimab alone, or in
combination with Agenus’ investigational anti-PD-1, balstilimab,
has shown clinical responses across nine metastatic, late-line
cancers. For more information about botensilimab trials, visit
www.clinicaltrials.gov with the identifiers NCT03860272,
NCT05608044, NCT05630183, and NCT05529316.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer and
infectious diseases with a comprehensive pipeline of immunological
agents. The company’s mission is to expand patient populations
benefiting from cancer immunotherapy through combination
approaches, using a broad repertoire of antibody therapeutics,
adoptive cell therapies (through MiNK Therapeutics) and adjuvants
(through SaponiQx). Agenus is headquartered in Lexington, MA. For
more information, visit www.agenusbio.com or @agenus_bio.
Information that may be important to investors will be routinely
posted on our website and social media channels.
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 regarding a Agenus’s
corporate event at ESMO and related presentation about its
botensilimab programs and any other statements containing the words
"may," "believes," "expects," "anticipates," "hopes," "intends,"
"plans," "forecasts," "estimates," "will," “establish,”
“potential,” “superiority,” “best in class,” 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. 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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