Combination of Balstilimab Plus Zalifrelimab Doubles Responses in 2L Cervical Cancer in Data to Be Presented at ESMO
September 16 2021 - 6:25PM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of checkpoint antibodies, cell therapies, adjuvants, and
vaccines designed to activate immune response to cancers and
infections, today presented final results from the Bal/Zal
combination study at the European Society for Medical Oncology
(ESMO) Virtual Conference 2021 in an abstract titled Balstilimab
(anti-PD-1) in combination with zalifrelimab (anti-CTLA-4): final
results from a Phase 2 study in patients (pts) with
recurrent/metastatic (R/M) cervical cancer (CC).
The data are being presented by lead investigator Dr. David
O’Malley, Professor of Obstetrics and Gynecology at The Ohio State
University College of Medicine and the Director of the Division of
Gynecologic Oncology, The Ohio State University Comprehensive
Cancer Center – Arthur G. James Cancer Hospital and Richard J.
Solove Research Institute (OSUCCC – James).
“With a median follow-up of almost 2 years, the Bal/Zal
combination showed high response rates, durable clinical activity,
and promising overall survival results”, said Steven O’Day, MD,
Chief Medical Officer of Agenus. “Furthermore, later this year we
expect to present new data on our next-generation CTLA-4 inhibitor
AGEN1181, which we expect to further define the positive role this
combination strategy could have in addressing unmet needs for
cancer patients.”
The Phase 2 trial was conducted in 155 patients with
recurrent/metastatic cervical cancer (R/M CC) which has limited
effective treatment options and disproportionately affects younger
women. In the 125 evaluable patients, the objective response rate
(ORR) in all patients was 26%, with 9% of patients achieving a
complete response, and 17% of patients achieving a partial
response. The median duration of response (DoR) was not reached
after a 19.4-month median follow-up. Notably, responses were also
observed in the PD-L1 negative and adenocarcinoma populations, with
9% of both patient groups achieving an ORR. Based on these
observations, we predict more than half of the patients to be alive
beyond 12 months*.
The Bal/Zal combination continued to show no unexpected
toxicities and no new safety signals were identified.
Detailed results from this trial will be presented in a Mini
Oral Session on September 19th from 11:35 – 11:40am ET by David
O’Malley, MD. In addition, in a Trials in Progress abstract, Agenus
presented the RaPiDS trial design for balstilimab alone or in
combination with zalifrelimab as second-line treatment for patients
with previously treated R/M CC.
“This trial represents the largest study evaluating PD-1 +
CTLA-4 inhibition in relapsed cervical cancer to date and shows
that the combination could represent a meaningful new option for
patients in this setting,” said Dr. O’Malley. “Efficacy outcomes
continued to improve over time, and the combination likewise
continued to show a positive safety profile.”
* Updated data to be presented during September 19th Mini Oral
session.
About AgenusAgenus 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. 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 MiNK Therapeutics subsidiary), adjuvants,
and proprietary cancer vaccine platforms. 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 StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding potential therapeutic benefit and future
clinical development plans for balstilimab, zalifrelimab, and
AGEN1181 alone and in combination with other agents. 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.
ContactAgenus Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From May 2024 to Jun 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Jun 2023 to Jun 2024