Agenus Data at SITC 2022 Highlight Durable Responses of Botensilimab / Balstilimab Combination in Nine Different Treatment-Resistant Cancers
14 November 2022 - 2:30PM
Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad
pipeline targeting cancer and infectious disease, announced
expanded data from the Company’s Phase 1 study of botensilimab
(Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients
with treatment-resistant tumors, including MSS-CRC, ovarian,
sarcoma and NSCLC. The data presented represents four of the most
mature data sets from the nine cancer types where responses have
been observed to date. The data was presented at a plenary session
at the Society for Immunotherapy of Cancer (SITC) annual meeting
and a company-hosted R&D event.
“This expanded dataset demonstrates the tremendous potential of
botensilimab and balstilimab to treat a wide range of
immunotherapy-resistant tumors,” said Steven O’Day, M.D., Chief
Medical Officer of Agenus. “Importantly, the superior efficacy we
observed in our MSS-CRC presentation at GI ESMO earlier this year
has remained consistent across a larger dataset. Further, we are
seeing a strong signal with higher response rates than has been
reported with other immunotherapies in multiple tumor types,
including anti-PD-(L)1 relapsed/refractory NSCLC. These data
provide compelling support for our ongoing Phase 2 botensilimab
development program and highlight the broad therapeutic potential
of botensilimab across solid tumors.”
Study Design and Highlights
Out of over 250 enrolled patients, data on 125 patients has
matured to efficacy and safety evaluation. These include four
primary expansion cohorts in MSS CRC, recurrent platinum
refractory/resistant ovarian, sarcoma and PD-(L)1
relapsed/refractory NSCLC. Patients in these cohorts received
either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg
balstilimab every 2 weeks, with imaging assessments every six
weeks. Fixed dosing was also permitted whereby patients received
botensilimab 150 mg every 6 weeks, and balstilimab 450 mg every 3
weeks. Trial enrollees were heavily pre-treated with the majority
receiving at least 3 prior lines of therapy.
MSS-CRC:
- 59 evaluable patients
- 76% failed on ≥3 prior lines of
therapy
- 34% did not respond to prior
experimental I-O
- 22% overall response rate: 1
complete response (CR), 12 partial responses (PR)
- Other PD-(L)1 + CTLA-4 combination
regimens in comparable patient populations achieved only 1-5%
response rates1,2
- 73% disease control rate
- Median duration of response not
reached
- 69% of responses are ongoing
- 31% of responses have already
exceeded 1 year
- Median Progression Free Survival
(mPFS) of 4.1 months; 12 month Overall Survival (OS) of 60.4%;
median Overall Survival (mOS) has not been reached
- Other PD-(L)1 + CTLA-4 combination regimens in comparable
patient populations achieved a 1.8 mPFS and 6.6 mOS
Ovarian:
- 19 evaluable patients
- 71% received ≥3 prior lines of
therapy
- 26% overall response rate: 1 CR, 4
PRs
- Other PD-(L)1 + CTLA-4 combination
regimens in comparable patient populations achieved only 3-10%
response rates3,4
- 63% disease control rate
- Median duration of response not
reached
Sarcoma:
- 12 evaluable patients
- 73% received ≥3 prior lines of
therapy
- 42% overall response rate: 1 CR, 4
PRs
- Other PD-(L)1 + CTLA-4 combination
regimens in comparable patient populations achieved only 12-16%
response rates5,6
- 50% response rate in angiosarcoma,
including 3 of 4 patients with visceral angiosarcoma
- Other PD-(L)1 + CTLA-4 combinations
achieved only 20-25% response rates with no reported responses in 7
treated patients with visceral angiosarcoma6,7
- 67% disease control rate
- Median duration of response not
reached
- 60% of responses have already
exceeded 1 year and are ongoing
Anti-PD-(L)1 Relapsed/Refractory NSCLC:
- 5 evaluable patients (including 1
evaluable patient dosed after the data cut-off)
- 60% overall response rate
- Other PD-(L)1 + CTLA-4 combination
regimens in comparable patient populations achieved only 6-13%
response rates8,9
- 80% disease control rate
- Median duration of response not
reached
- 67% of responses are ongoing
Tolerability:
Botensilimab was well tolerated, with no new immune-mediated
safety signals outside of those observed in the class. Rates of
gastrointestinal and skin toxicities were comparable to those
reported with first-generation CTLA-4 inhibitors, while other
immune mediated toxicities were less frequent than expected,
consistent with botensilimab’s design to reduce complement
binding.
“There is an urgent need to develop new therapies for patients
suffering with cold and refractory tumors as current standards of
care typically offer only single-digit response rates, “said
Breelyn Wilky, M.D., Principal Investigator and Director of Sarcoma
Medical Oncology at the University of Colorado School of Medicine.
“The robust and durable clinical responses demonstrated by
botensilimab and balstilimab in this study across a wide spectrum
of refractory tumor types, coupled with its well-tolerated safety
profile, provide strong support for the further development of this
combination in a broad range of patients.”
Presentation Details:
Abstract Number: 778
Abstract Title: Botensilimab, a novel innate/adaptive immune
activator, plus or minus balstilimab (anti-PD-1) in 'cold' and I-O
refractory metastatic solid tumors
Presenting Author: Breelyn A. Wilky, M.D., Director of Sarcoma
Medical Oncology, Deputy Associate Director for Clinical Research
University of Colorado School of Medicine
The data were presented on Saturday, November 12 at both the
Society for Immunotherapy of Cancer and “The Road Taken” R&D
event hosted offsite by Agenus. An archived version of each
presentation will be available on the Agenus website.
References1 Chen et al. JAMA Oncol. 20202
Overman et al. ASCO 20163
https://clinicaltrials.gov/ct2/show/results/NCT01928394 4
Hinchcliff et al. Gynecologic Oncology 20215 D’Angelo et al. Lancet
Oncology 20186 Somaiah et al. Lancet Oncology 20227 Wagner et al
JITC 20218 https://clinicaltrials.gov/ct2/show/results/NCT027505149
Fisher et al. ASCO 2019
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.
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our website: www.agenusbio.com. Agenus cautions investors not to
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Contact
Agenus Inc.Nico FrelickInvestor
Relations781-674-4616nico.frelick@agenusbio.com
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