Breakthrough Data on Botensilimab/Balstilimab in MSS CRC Presented at the 2024 ASCO Annual Meeting
24 May 2024 - 7:10AM
Business Wire
New analysis highlights BOT/BAL activity across
challenging metastatic disease sites
Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing
novel immunological agents to treat various cancers, today
announced a novel analysis from the Phase 1b trial of botensilimab
in combination with balstilimab (BOT/BAL) in relapsed/refractory
microsatellite stable colorectal cancer (r/r MSS CRC) with no
active liver metastases (NLM) will be presented at the upcoming
2024 American Society of Clinical Oncology (ASCO) Annual Meeting on
June 1, 2024. The analysis shows that BOT/BAL is active in
metastatic sites beyond the lungs and lymph nodes, including the
peritoneum, soft tissue, and brain, which have historically been
unresponsive to treatment.
“The findings observed in this analysis are notable in that they
are seen within challenging and historically unresponsive
metastatic sites of disease,” said Dr. Steven O'Day, Chief Medical
Officer at Agenus. “Seeing broad activity beyond the lungs and
lymph nodes is rare for immunotherapy in MSS mCRC, making BOT/BAL
stand out from other treatments. We are committed to advancing
BOT/BAL for those living with cancer, with the intent to provide
durable long-term benefits.”
Patient Demographics
- A total of 77 patients with NLM MSS mCRC were treated with 1 or
2 mg/kg BOT every 6 weeks plus 3 mg/kg BAL every 2 weeks.
- Patients were heavily pre-treated, with a median of four prior
lines of therapy, including 21% who received prior PD-(L)1/CTLA-4
therapy.
- Location of NLM sites: 62 patients (81%) had lung involvement,
33 patients (43%) had peritoneal involvement, 32 (42%) patients had
lymph node involvement, 15 patients (19%) had soft tissue
involvement, and 18 patients (23%) had other sites including the
bone and brain.
Clinical Findings
- Across different NLM sites, overall response rates (ORR) ranged
from 18-33% and disease control rates (DCR) ranged from 67-82%.
Overall survival (OS) remained consistent and ranged from 20.7
months to not reached (NR).
- No new safety signals were observed.
Presentation Details:
Abstract Title: Botensilimab plus balstilimab in microsatellite
stable metastatic colorectal cancer: Assessing efficacy in
non-liver metastatic sites. Abstract Number: 3556 Presenting
Author: Marwan Fakih, MD, Division Head, GI Medical Oncology, City
of Hope Comprehensive Cancer Center Session: Poster Session –
Gastrointestinal Cancer – Colorectal and Anal Session Date and
Time: June 1, 2024, at 1:30 p.m. – 4:30 p.m. CT
About Botensilimab
Botensilimab is a human Fc enhanced CTLA-4 blocking antibody
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 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 900 patients have been treated with botensilimab
in phase 1 and phase 2 clinical trials. Botensilimab alone, or in
combination with Agenus’ investigational PD-1 antibody,
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 its botensilimab
and balstilimab programs, expected regulatory timelines and
filings, 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 Annual Report on
Form 10-K for 2022, and subsequent Quarterly Reports on Form 10-Q
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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