Median Overall Survival of 20.9 Months for
Patients Without Active Liver Metastases Surpasses the Recently
Reported 12.9-Month Benchmark with Standard of Care in this
Population
Immuno-oncology leader, Agenus (Nasdaq: AGEN), shared promising
data today from its Phase 1b trial on the botensilimab and
balstilimab combination at a late-breaking session at the 2023 ESMO
World Congress on Gastrointestinal Cancer (ESMO GI). The new data
show substantial survival benefits and long-lasting responses for
patients with non-MSI-H (microsatellite stable or
non-microsatellite instability-high) metastatic colorectal cancer
previously resistant to chemotherapy and/or immunotherapy.
“The data from our expanded cohort demonstrate remarkable median
overall survival and sustained responses in heavily pre-treated
patients that historically haven’t responded to immunotherapy.
These findings provide evidence of the benefit of
botensilimab/balstilimab in metastatic colorectal cancer, the
second leading cause of cancer death in the U.S.,” said Dr. Steven
O’Day, Chief Medical Officer at Agenus. “Our clinical research has
shown confirmed responses in 8 other refractory tumor types,
indicating the potential to transform clinical practice and patient
outcomes for multiple challenging cancers.”
Dr. Andrea Bullock, Assistant Professor of Medicine, Harvard
Medical School, and study investigator, commented, "The new
survival data underscore the potential of the
botensilimab/balstilimab combination as an important treatment
option for patients with non-MSI-H colorectal cancer. The patients
in our study face one of the most challenging cancers to treat and
represent the largest patient population with colorectal cancer
where only a quarter of patients survive beyond one year with
standard of care therapy. Botensilimab plus balstilimab continues
to show deep and durable responses with 69% of objective responses
still ongoing at the data cutoff."
Agenus is planning to submit its first Biologics License
Application to the U.S. Food & Drug Administration (FDA) for
patients with non-MSI-H metastatic colorectal cancer. The ongoing
global randomized phase 2 trial for patients with non-active liver
metastases has been granted Fast Track Designation from the FDA.
Additionally, global randomized Phase 2 trials for the
botensilimab/balstilimab combination in melanoma and
botensilimab/chemotherapy in pancreatic cancer are underway, with
plans to initiate Phase 3 studies in colorectal and non-small cell
lung cancer (NSCLC).
Study Design:
The study enrolled 101 patients with refractory non-MSI-H
metastatic colorectal cancer who were administered botensilimab
(either 1 or 2 mg/kg every six weeks) and balstilimab (3 mg/kg
every two weeks).
The patients had a median of four prior therapy lines, with 25%
having failed previous immunotherapy.
Efficacy was evaluated in 87 patients who had undergone at least
one six-week post-baseline imaging scan. Of these, 69 patients had
no active liver metastases, defined as patients with no history of
liver metastases or those with metastases that were treated or
ablated without recurrence.
Half of the patients treated had poor-prognostic metastatic
sites beyond the liver, such as bone and soft tissue.
Survival:
Patients without active liver metastases had a 12-month overall
survival (OS) estimate of 74% and a median overall survival (mOS)
of 20.9 months, surpassing the recently reported 12.9-month
benchmark with standard of care.
Patients with active liver metastases had a 12-month OS estimate
of 30% and a mOS of 8.7 months, surpassing the recently reported
5.9-month benchmark with standard of care. The
botensilimab/balstilimab combination showed a survival benefit,
regardless of RECIST 1.1 responses.
mOS estimates for patients, categorized by liver status, were
comparable between the efficacy evaluable and the intent-to-treat
populations.
Objective Responses:
Evaluable patients without active liver metastases showed a
confirmed objective response rate of 23% and a disease control rate
of 80%, significantly higher than the reported response rate of 3%
with standard of care.
The responses were durable, with 69% of objective responses
ongoing at data cutoff. Response durations ranged from 1.4+ months
in recently treated patients to over 24.3+ months.
Tolerability:
The botensilimab/balstilimab combination demonstrated a
manageable safety profile, with no new safety concerns
emerging.
Presentation Details:
Abstract Title: Results from an expanded phase 1 trial of
botensilimab, a multifunctional anti-CTLA-4, plus balstilimab
(anti-PD-1) for metastatic heavily pretreated microsatellite stable
colorectal cancer (NCT03860272)
Abstract Number: LBA-4
Presenting Author: Andrea J. Bullock, MD, MPH, Assistant
Professor of Medicine, Division of Medical Oncology, Beth Israel
Deaconess Medical Center
Session XVIII: Immune Mechanisms and Microbiome in GI
Tumors
Session Time: 6/30/2023, 5:15pm - 6:30pm CEST
Presentation Date and Time: 6/30/2023, 6:00pm – 6:10pm
CEST
The presentation can be accessed in the publications section of
our website at https://agenusbio.com/publications/.
References:
Grothey et. al. "Regorafenib monotherapy for previously treated
metastatic colorectal cancer (CORRECT): an international,
multicentre, randomised, placebo-controlled, phase 3 trial." Lancet
2013, 381(9863): 303-12
Mayer et. al. "Randomized trial of TAS-102 for refractory
metastatic colorectal cancer." NEJM 2015, 372(20): 1909-19
Cohen et al. "Prognostic value of liver metastases in colorectal
cancer treated by systemic therapy: An ARCAD pooled analysis." ASCO
Annual Meeting 2023, Abstract 3554
About Botensilimab
Botensilimab, an investigational multifunctional CTLA-4
antibody, is designed to extend immunotherapy benefits to "cold"
tumors, which have not historically responded to standard of care
or investigational therapies. Besides binding to the CTLA-4
receptor, its Fc-enhanced structure induces a memory immune
response, downregulates regulatory T cells, and activates T cells,
thereby enhancing immune responses. In a Phase 1b clinical study
involving over 500 patients, botensilimab has shown clinical
responses in 9 solid tumor cancers, either alone or in combination
with Agenus’ PD-1 antibody, balstilimab. For more information about
botensilimab trials, visit www.clinicaltrials.gov with the
identifiers 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 follow us on LinkedIn
and Twitter @agenus_bio.
Forward-Looking
Statements
This press release contains forward-looking statements under the
safe harbor provisions of federal securities laws. These include
statements related to botensilimab and balstilimab’s use, such as
anticipated therapeutic benefit, efficacy, mechanism of action,
potency, durability, and safety profile of the Company's
therapeutic candidates. Any statements containing "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"forecasts," "estimates," "will," “establish,” “potential,”
“superiority,” “best in class,” and similar expressions signify
forward-looking statements. Actual results could differ materially
due to risks and uncertainties, including those described under the
Risk Factors section in our most recent Quarterly Report on Form
10-Q or Annual Report on Form 10-K filed with the Securities and
Exchange Commission. Agenus urges investors not to place
significant reliance on the forward-looking statements in this
release. These statements only reflect the views 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230630250476/en/
Investor Zack Armen (917)
362-1370 Zack.Armen@agenusbio.com
Media Stephanie Fagan
Stephanie.Fagan@agenusbio.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Jul 2023 to Jul 2024