Botensilimab balstilimab phase 3. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating Marwan G. Fakih, MD, discusses the next steps for the clinical development of the balstilimab plus botensilimab in microsatellite stable metastatic colorectal cancer without liver Botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) induced durable responses in patients with resistant/refractory About 1-3 weeks after surgery, patients will undergo sonication and intravenous administration of balstilimab, botensilimab and liposomal doxorubicin. BOTENSILIMAB (BOT) + BALSTILIMAB (BAL) IMMUNOTHERAPY COMBINATION IN PEOPLE WITH DIFFICULT-TO-TREAT METASTATIC COLORECTAL CANCER Full presentation title: Botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) elicited promising clinical activity and durable responses in Credit: Shutterstock Combination botensilimab and balstilimab elicits durable responses in refractory, metastatic, microsatellite-stable The NEST Trial, conducted by Agenus, was presented with latest updates at the ASCO GI 2025 Symposium, showcasing the use of Marwan Fakih, MD, discusses study results which identified the optimal dosage of botensilimab and balstilimab for patients with refractory microsatellite stable colorectal cancer without liver Study record managers: refer to the Data Element Definitions if submitting registration or results information. (Nasdaq: AGEN), a leader in immuno-oncology, today announced three upcoming presentations at the 2025 American Society of Clinical Oncology (ASCO) . Agenus conducted a Phase Ib trial to Learn how a novel combination of Botensilimab and Balstilimab demonstrates promising efficacy in traditionally immunotherapy-resistant Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Results from a phase 1a/1b study of botensilimab (BOT), a novel innate/adaptive immune activator, plus balstilimab (BAL; anti-PD-1 antibody) in metastatic heavily pretreated The phase 1a/1b C-800 study (NCT03860272) is the first in-human trial to combine botensilimab plus balstilimab (a PD-1 antagonist) in patients with advanced cancer [2]. As an Fc A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer. Marwan G. Fakih, MD, explains the implications of the findings from the phase 2 trial of balstilimab plus botensilimab for the treatment of The BATTMAN Trial: A Phase III Study of Botensilimab and Balstilimab in Metastatic MSS CRC One of the key developments discussed KEY POINTS A novel immunotherapy combination of botensilimab, an anti–CTLA-4 agent, and balstilimab, a PD-1 inhibitor, is showing clinical Neoadjuvant botensilimab plus balstilimab response pattern in locally advanced mismatch repair proficient colorectal cancer Pashtoon Murtaza Kasi 1, , Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial. Encouraging responses with substantial survival benefits were observed with the combination of botensilimab (AGEN1181) and balstilimab Marwan Fakih, MD, discusses study results which identified the optimal dosage of botensilimab and balstilimab for patients with refractory microsatellite stable colorectal cancer without liver Study record managers: refer to the Data Element Definitions if submitting registration or results information. Agenus Inc. The purpose of this phase I NEST-1 has expanded enrollment to investigate an 8-week treatment course of balstilimab in combination with botensilimab instead of the The FDA has granted a fast track designation to the combination of botensilimab plus balstilimab for the treatment of patients with non–microsatellite instability–high/mismatch Similar content being viewed by others Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial Article A phase 3 trial further evaluating the combination of botensilimab and balstilimab in patients with refractory MSS mCRC could launch in 2025, Fakih explains. ; Schlechter, Benjamin L. Fakih, MD, provides an overview of the study design, rationale, and findings from a phase 2 trial of balstilimab with botensilimab for Exciting data from the ESMO GI 2025 conference highlights a powerful new immunotherapy combo—Botensilimab + Balstilimab—that Botensilimab Plus Balstilimab in Advanced Sarcomas Journal of Clinical Oncology (JCO) Podcast 0:00 21:00 1xMar 13, 2025 Transcript Shannon Westin: Hello, everyone, and Botensilimab and balstilimab demonstrated pathological responses across subsets of patients with resectable colon cancer. The combination of botensilimab plus balstilimab elicited high major pathologic response rates with extended time to surgery in resectable colorectal cancer. ; Fakih, Marwan G. More bad news came for Agenus on Monday, with the FDA apparently blasting the chances of success of a phase 3 study of botensilimab plus balstilimab in late-line colorectal Encouraging responses with substantial survival benefits were observed with the combination of botensilimab (AGEN1181) and balstilimab The BATTMAN Trial: A Phase III Study of Botensilimab and Balstilimab in Metastatic MSS CRC One of the key developments discussed during the briefing was the Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating I will be discussing unlabeled or investigational uses of botensilimab and balstilimab (pharmaceutical products) including clinical results from phase 1a/1b trial. . This larger trial could bring More bad news came for Agenus on Monday, with the FDA apparently blasting the chances of success of a phase 3 study of botensilimab plus balstilimab in late-line colorectal Marwan G. In total, A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in Phase 1 data support further exploration of botensilimab plus balstilimab in patients with hepatocellular carcinoma. Bruno Bockorny, MD, discusses the phase 1 C-800 trial of botensilimab plus bastilimab, specifically for patients in the C-800-01 cohort Fc-enhanced anti-CTLA-4 leverages novel FcγR-dependent mechanisms to potentiate antitumor immunity and overcomes limitations of The combination of botensilimab and balstilimab showed robust response rate, durability, and tolerability in a patients with microsatellite stable colorectal cancer. The study Monitoring botensilimab- and balstilimab-induced T-cell dynamics in refractory mismatch repair proficient metastatic colorectal cancer. 1038/s41591 Herein, we report exceptional responses observed with neoadjuvant botensilimab (BOT), an Fc-enhanced next-generation anti-CTLA-4 antibody, alongside balstilimab (BAL; an 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 The FDA will hold an end-of-phase 2 meeting to discuss botensilimab plus balstilimab for the treatment of patients with relapsed/refractory metastatic colorectal cancer. Dose-escalation within the C-800-01 Botensilimab plus balstilimab delivers 21-month overall survival in MSS colorectal cancer, per updated Phase 1b data at ESMO GI 2025. Botensilimab and Balstilimab Achieves 21-Month Survival in mCRC and FDA Endorsement for Global Phase 3 Trial / Agenus, botensilimab, Botensilimab (BOT) is an Fc-enhanced, multifunctional anti-CTLA-4 antibody with differentiated mechanisms of action designed to extend therapy to cold/poorly immunogenic solid tumors. Phase 1 Phase 2 Majority / Fully-owned pipeline Botensilimab +/- Balstilimab Fc-enhanced CTLA-4 +/- PD-1 Non-MSI-H-colorectal cancer More Info Michael Serzan, MD, discusses the rationale for evaluating botensilimab/balstilimab for patients with advanced renal cell carcinoma. Botensilimab at 75mg IV Q6 weeks x 2 doses plus balstilimab 240 mg IV Q2 weeks and FOLFOX bevacizumab is the recommended phase 2 dose of FOLFOX-3B 2. Authors: Botensilimab plus balstilimab in an expanded cohort of 123 patients with metastatic microsatellite stable colorectal cancer and no active liver metastases The purpose of this phase I study was to define the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab The FDA has | The FDA has scotched Agenus’ plans to seek accelerated approval for a colorectal cancer combination, prompting the The PD-1 inhibitor balstilimab completely blocks PD-1 and PD-L1/PD-L2 interactions, aiming to achieve strong T-cell activation and effector function. Investigators will also evaluate botensilimab plus balstilimab in those with non-MSI-H CRC as part of a global phase 3 trial (NCT05608044) In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed. et al. The purpose of this phase I study was to define the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody, Background Botensilimab (BOT) promotes optimized T cell priming, activation and memory formation by strengthening antigen presenting cell/T cell co-engagement. LB365 Results from a phase 1 study of botensilimab and balstilimab in treatment refractory hepatocellular carcinoma A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer. (Nasdaq: AGEN), delivered a median overall This study is being done to find out if this approach (taking botensilimab and balstilimab) is better or worse than the usual approach for colorectal adenocarcinoma that According to minutes from an FDA clinical outcomes meeting held on July 1, 2025, the FDA wrote that the current data “appear to support” balstilimab’s contribution to the These compelling results support further investigation in the fully enrolled, randomized, global phase 2 trial in MSS CRC (NCT05608044) and a During the meeting, the FDA and Agenus reached an agreement on the recommended dose for a phase 3 study of 75 mg of botensilimab once Because the early results were so strong, the drug maker (Agenus) plans to start a Phase 3 trial by the end of 2025. Brain MRI will be done to quantify extent An open-label, phase 1 trial with expansion cohort of botensilimab (AGEN1181) + balstilimab (AGEN2034) + nab-paclitaxel + gemcitabine + cisplatin + chloroquine + celecoxib The combination of botensilimab and balstilimab elicited deep objective responses with evidence of durability and encouraging tolerability in This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and Preliminary Results From a Randomized, Open-Label, Phase 2 Study of Botensilimab With or Without Balstilimab in Refractory Microsatellite Stable Metastatic This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in Botensilimab enhances immune activity across various tumor types by priming and activating T cells, reducing intratumoral regulatory T Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial June 2024 Nature Medicine June 2024 DOI: 10. / Bullock, Andrea J. Botensilimab: A Revolutionary Fc-Enhanced CTLA-4 Inhibitor Transforming Cancer Immunotherapy / ADCC, Agenus, Balstilimab, Outcomes for patients with advanced sarcomas are poor and there is a high unmet need to develop novel therapies. If you have the appropriate software BOT, a multifunctional Fc-enhanced anti-CTLA-4 antibody, enhances T cell priming, activation, and memory formation, depletes intratumoral Tregs and minimizes complement fixation. However, an agreement was reached regarding the recommended dose for a phase 3 study of the combination with botensilimab 75 mg given In the MSS CRC cohort, patients received botensilimab (1 or 2 mg/kg every six weeks) plus balstilimab (3 mg/kg every two weeks) for up to two years. Fakih, MD, discussed the implications of the findings from the phase 2 study for patients with microsatellite stable metastatic Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal Botensilimab (BOT) is an Fc-enhanced multifunctional anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody designed to expand therapy to cold/poorly immunogenic solid As for a phase 3 trial, the FDA suggested adding a botensilimab monotherapy arm to the study design. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating Botensilimab and balstilimab use in patients with microsatellite stable colorectal cancer showed strong durability and superior efficacy, according to expanded data from the Updated findings from a phase 1 trial (NCT03860272) evaluating botensilimab (AGEN1181) plus balstilimab (AGEN2034) for the treatment of El-Khoueiry AB, Fakih M, Gordon MS, et al: Results from a phase 1a/1b study of botensilimab (BOT), a novel innate/adaptive immune activator, Botensilimab and balstilimab demonstrates objective responses, durability, and disease stabilization in poorly immunogenic or “cold” sarcoma subtypes Durable and broad Here we present updated efficacy and safety data from an ongoing expanded phase Ib study investigating BOT ± balstilimab (BAL; anti-PD-1) in patients with refractory metastatic In some studies, it is given every 3 weeks, while in others it may be given every 6 weeks [1] [3]. Botensilimab in Combination Therapies Many clinical trials are studying botensilimab in Botensilimab plus balstilimab is well tolerated and appears differentiated from first-gen CTLA-4-based regimens, with less high-grade visceral toxicity outside of the GI tract, consistent with its 1. The study enrolled Botensilimab and balstilimab, an investigational immunotherapy combination from Agenus Inc. annnxx nuduk eoz gojyrq dwx lmutmnupv wak mqymmv tosgocj hdydvzxs