- 24% overall response rate and 73% disease control rate, in heavily pretreated patients with a median of 4 prior lines of therapy
- Responses to botensilimab/balstilimab were durable, with 80% ongoing at data cutoff and median duration of response not reached
- Randomized Phase 2 global study of botensilimab/balstilimab in MSS CRC to begin this year
- Agenus will host a webcast today at 10:00 a.m. EDT
LEXINGTON, Mass., June 29, 2022 (GLOBE NEWSWIRE) — Agenus (AGEN), an immuno-oncology company with an extensive portfolio of therapeutic products designed to activate the immune response to cancers and infections, announced today Today expanded data from the Phase 1b study of botensilimab (Fc-boosted anti-CTLA-4) and balstilimab (anti-PD-1) in patients with microsatellite stable colorectal cancer (MSS CRC). The data demonstrates that the combination provides strong durability and superior efficacy to what has been reported in separate trials for standard of care and other investigational therapies in CRC MSS 2L+.
“These data reinforce the strong therapeutic potential of botensilimab, when used in combination with balstilimab, in cold tumors such as MSS CRC,” said Steven O’Day, MD, Chief Medical Officer at Agenus. “To date, botensilimab has demonstrated activity in nine cold- and treatment-resistant cancers, and we plan to initiate a robust global Phase 2 program, including in the MSS CRC, later this year.”
A total of 41 evaluable patients with metastatic MS CRC received 1 or 2 mg/kg botensilimab Q6W and 3 mg/kg balstilimab Q2W. Patients were heavily pretreated, with a median of 4 prior lines of treatment, and 34% had received prior immunotherapy. The botensilimab/balstilimab combination produced superior responses and strong durability, compared to what has been reported in separate trials for standard of care and other combinations currently in development.
- 24% overall response rate
- 73% disease control rate (partial response + stable disease)
- 50% objective responses with tumor reduction greater than 50%
- 80% objective responses in progress at the data cut-off date
- 30% objective responses exceeding 1 year
- Objective responses in 5 patients with RAS mutations for an overall response rate of 24% and a disease control rate of 81% in this population; other PD-1 combinations in separate trials reported only rare responses in this population (≤1% response rate)
- Responses seen in patients with metastases historically resistant to immunotherapy, including patients with malignant pleural effusions, soft tissue, peritoneal, retroperitoneal, and bone metastases
- Botensilimab was well tolerated, with no grade 4/5 treatment-related adverse events
- Gastrointestinal and skin toxicity rates were comparable to those reported with first-generation CTLA-4 inhibitors
“Colorectal cancer is the second leading cause of cancer-related death worldwide, with approximately 95% classified as microsatellite stable and historically unresponsive to immunotherapy. Patients with treatment-resistant CRC MSS lack effective options, with the standard of care offering only a 1-2% response rate and an expected median survival of 6-7 months,” said Anthony El -Khoueiry, MD, director of the Phase I program at USC. Norris Comprehensive Cancer Center, Keck Medicine at USC. “The combination of robust response rate, durability and tolerability demonstrated by botensilimab and balstilimab supports the further development of the combination in MSS CRC, as well as more broadly, in other cold-resistant tumors. and treatment.”
The data was presented today at 7:05 a.m. EDT during a late-breaking oral presentation at the ESMO World Congress on Gastrointestinal Cancer in Barcelona, Spain.
Abstract title: Botensilimab, a novel innate/adaptive immune enhancer, plus balstilimab (anti-PD-1) for highly pretreated metastatic stable microsatellite colorectal cancer
Abstract number: LBA-09
Presenting Author: Dr. Anthony El-Khoueiry, MD, Associate Director of Clinical Research at USC Norris Comprehensive Cancer Center, Keck School of Medicine
Webcast for investors
The company will host an investor webcast today at 10:00 a.m. EDT to review this data. Participants can register here, or in the Investors section of the Agenus website at investor.agenusbio.com. The webcast will include presentations by the speakers below and will be followed by a Q&A session:
- Steven O’Day, MD, Agenus Chief Medical Officer
- Dr. Anthony El-Khoueiry, MD, Associate Director of Clinical Research at USC Norris Comprehensive Cancer Center, Keck School of Medicine
- Dr. Manuel Hidalgo, chief of the division of hematology and medical oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital, and
- Dr. Heinz-Josef Lenz, MD, Professor of Medicine and J. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine
Following the webcast, an archived version will be available on the Agenus website.
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that mobilize the body’s immune system to fight cancer and infection. The Company’s vision is to expand patient populations benefiting from cancer immunotherapy by pursuing combined approaches that leverage a broad repertoire of therapeutic antibodies, adoptive cell therapies (through its subsidiary MiNK Therapeutics) and adjuvants (via 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 capability to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter account @agenus_bio. Information that may be important to investors will be regularly posted on our website and on Twitter.
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to our technologies, therapeutic candidates and capabilities, for example, statements regarding the benefits and the therapeutic efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or with other agents ; statements regarding future plans, including research, clinical, regulatory and marketing plans; and any other statement containing the words “may”, “believes”, “expects”, “anticipates”, “hopes”, “intends”, “plans”, “will” 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 in 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 and available on our website. : www.agenusbio.com. Agenus cautions investors not to place significant reliance on any 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, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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