2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:Ta16,Patients with platinum-resistant/refractory ovarian cancer (PROC) experience suboptimal outcomes, highlighting an immediate need for novel therapies. This phase 1b study investigated the safety and efficacy of botensilimab (BOT), a fragment crystallizable (Fc)-enhanced anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody with differentiated mechanisms of action from first-generation CTLA-4 inhibitors, plus balstilimab (BAL; anti-programmed cell death protein 1 antibody), in an expanded cohort of patients with treatment-refractory ovarian cancer. BOT was administered intravenously at 1 mg/kg or 2 mg/kg every 6 weeks in combination with BAL intravenously at 3 mg/kg every 2 weeks (up to 2 years). The primary objectives were to assess safety and tolerability. Efficacy end points included objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1. Overall survival (OS) was an exploratory end point. Overall, 44 patients were evaluable for safety (with a median of 3 prior lines of therapy; median follow-up 9.6 months (range, 0.6-36.6)), and 35 for efficacy. The most common treatment-related adverse event was diarrhea/colitis (43%; 16% grade 3) with no treatment-related deaths. RECIST-confirmed ORR was 23% (8/35; 95% CI 10% to 40%; one complete (CR), seven partial responses (PRs)) and clinical benefit rate (CR, PR, or stable disease ≥24 weeks) was 31% (11/35; 95% CI 17% to 49%). Median DOR was 9.7 months (95% CI 2.8 to not reached (NR)), median PFS was 2.8 months (95% CI 1.4 to 5.5), median OS was 14.8 months (95% CI 12.1 to NR), and 12-month OS was 75% (95% CI 55% to 86%). Immune phenotypic analyses and biomarker data revealed significantly higher FcγRIIIA+CD11c+ cells and higher programmed death-ligand 1 expression in responding patients, a strong association between T-cell infiltrated tumors and clinical benefit, and differences in immune architecture across histologic subtypes. The BOT/BAL combination demonstrated deep, durable responses and complete remissions in patients with treatment-refractory ovarian cancer where no standard treatments are currently available. RECIST under-represented clinical benefit with 11 patients achieving prolonged/clinically meaningful stable disease (or better) for ≥24 weeks. Toxicities were manageable and reversible. The encouraging clinical activity of BOT/BAL in heavily pretreated patients, as well as biomarker associations, warrants further investigation of this combination.31:Tc64, Background Patients with platinum-resistant/refractory ovarian cancer (PROC) experience suboptimal outcomes, highlighting an immediate need for novel therapies. This phase 1b study investigated the safety and efficacy of botensilimab (BOT), a fragment crystallizable (Fc)-enhanced anti–cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody with differentiated mechanisms of action from first-generation CTLA-4 inhibitors, plus balstilimab (BAL; anti–programmed cell death protein 1 antibody), in an expanded cohort of patients with treatment-refractory ovarian cancer. Methods BOT was administered intravenously at 1 mg/kg or 2 mg/kg every 6 weeks in combination with BAL intravenously at 3 mg/kg every 2 weeks (up to 2 years). The primary objectives were to assess safety and tolerability. Efficacy end points included objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1. Overall survival (OS) was an exploratory end point. Results Overall, 44 patients were evaluable for safety (with a median of 3 prior lines of therapy; median follow-up 9.6 months (range, 0.6—36.6)), and 35 for efficacy. The most common treatment-related adverse event was diarrhea/colitis (43%; 16% grade 3) with no treatment-related deaths. RECIST-confirmed ORR was 23% (8/35; 95% CI 10% to 40%; one complete (CR), seven partial responses (PRs)) and clinical benefit rate (CR, PR, or stable disease ≥24 weeks) was 31% (11/35; 95% CI 17% to 49%). Median DOR was 9.7 months (95% CI 2.8 to not reached (NR)), median PFS was 2.8 months (95% CI 1.4 to 5.5), median OS was 14.8 months (95% CI 12.1 to NR), and 12-month OS was 75% (95% CI 55% to 86%). Immune phenotypic analyses and biomarker data revealed significantly higher FcγRIIIA+CD11c+ cells and higher programmed death-ligand 1 expression in responding patients, a strong association between T-cell infiltrated tumors and clinical benefit, and differences in immune architecture across histologic subtypes. Conclusion The BOT/BAL combination demonstrated deep, durable responses and complete remissions in patients with treatment-refractory ovarian cancer where no standard treatments are currently available. RECIST under-represented clinical benefit with 11 patients achieving prolonged/clinically meaningful stable disease (or better) for ≥24 weeks. Toxicities were manageable and reversible. The encouraging clinical activity of BOT/BAL in heavily pretreated patients, as well as biomarker associations, warrants further investigation of this combination. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"botensilimab: generic Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on botensilimab (generic). Clinician-written summaries and actionable practice insights. 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In late-line–exposed patients (n=37), ORR was 22% and median OS was 16.2 months.","limitations":"Single-arm phase 1b design with no comparator arm limits causal inference. The NLM subgroup restriction (no active liver metastases) narrows generalizability to the broader MSS mCRC population. Late-line–exposed subgroup analysis (n=37) was post hoc.","practice_takeaway":"For patients with MSS mCRC and no active liver metastases, BOT+BAL achieved durable responses and a 33% 3-year OS rate in a heavily pretreated population — a setting where conventional immunotherapy rarely works. Clinicians should note that liver metastasis status appears to be a key patient-selection criterion for this regimen."}},{"doi":"10.1158/1078-0432.ccr-26-0998","pmid":"42644724","title":"Neoadjuvant Botensilimab/Balstilimab for localized mismatch repair proficient and deficient colon cancer: Results of the NEST phase 2 clinical trial","journal_title":"Clinical Cancer Research","journal_issn":"1078-0432","published_at":"2026-08-26T00:00:00.000Z","url":"https://doi.org/10.1158/1078-0432.ccr-26-0998","source_score":115,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-30T06:19:58.023Z","updated_at":"2026-08-30T06:19:58.023Z","tags":[{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"condition","value":"Colorectal Cancer","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"condition","value":"Mismatch Repair Deficient Colorectal Cancer","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"condition","value":"Mismatch Repair Proficient Colorectal Cancer","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"generic","value":"balstilimab","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"generic","value":"botensilimab","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"modality","value":"CTLA-4 Inhibitor","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"modality","value":"Neoadjuvant Immunotherapy","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"modality","value":"PD-1 Inhibitor","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"sample_size","value":"n=24","value_numeric":24},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"study_design","value":"Phase 2 Clinical Trial","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"warning","value":"'practice_changing' impact flag applied cautiously: the pMMR MPR rate is notable for a historically resistant population, but the single-arm design and small N limit definitive conclusions.","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"warning","value":"Sex distribution is not explicitly reported in the abstract or results; 'mixed' is assumed.","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"warning","value":"The dMMR subgroup is very small (n=4 tumors), making the 100% MPR rate and its wide confidence interval (40%–100%) highly imprecise — interpret with caution.","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-26-0998","tag_type":"warning","value":"The study enrolled patients with synchronous primary tumors (2 patients, 26 tumors from 24 patients), which may introduce complexity in per-patient vs. per-tumor analyses.","value_numeric":null}],"summaries":{"what_studied":"Phase 2 trial (NEST) evaluating neoadjuvant botensilimab (Fc-enhanced CTLA-4 inhibitor) plus balstilimab (PD-1 inhibitor) in adults with resectable, non-metastatic colorectal cancer — both mismatch repair proficient (pMMR, n=22 tumors) and deficient (dMMR, n=4 tumors) — prior to planned surgical resection.","key_result":"Major pathologic response (MPR) rate was **41% (95% CI, 21%–64%)** in pMMR and **100% (95% CI, 40%–100%)** in dMMR tumors; no patient had surgery delayed by treatment. Tumor microenvironment changes included increased CD8+ T-cell density and decreased FOXP3+ Treg infiltration in responders.","limitations":"- Very small sample size (24 patients, 26 tumors), limiting precision of estimates — especially for dMMR (n=4).\n- Single-arm design with no comparator arm.\n- Pathologic response is a surrogate endpoint; long-term survival outcomes are not yet available.","practice_takeaway":"Botensilimab + balstilimab showed promising MPR rates in pMMR colon cancer — a population historically resistant to immunotherapy — without delaying surgery. Clinicians should watch for larger confirmatory trials before adopting this regimen outside a study setting."}},{"doi":"10.1136/jitc-2025-013222","pmid":"41436232","title":"Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab (anti–PD-1 antibody) in patients with treatment-refractory ovarian cancer","journal_title":"Journal for ImmunoTherapy of Cancer","journal_issn":"2051-1426","published_at":"2025-12-24T00:00:00.000Z","url":"https://doi.org/10.1136/jitc-2025-013222","source_score":78,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2025-12-25","doi":"10.1136/jitc-2025-013222","days":"30","issn":"2051-1426","rank":"10","field":"Clinical Medicine","score":"78","category":"Immunology","categories":["Immunology"],"_categories":["Immunology"]},"pubmed":{"doi":"10.1136/jitc-2025-013222","title":"Botensilimab (Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (anti-PD-1 antibody) in patients with treatment-refractory ovarian cancer.","journal":"Journal for immunotherapy of cancer","methods":"","results":"Overall, 44 patients were evaluable for safety (with a median of 3 prior lines of therapy; median follow-up 9.6 months (range, 0.6-36.6)), and 35 for efficacy. The most common treatment-related adverse event was diarrhea/colitis (43%; 16% grade 3) with no treatment-related deaths. RECIST-confirmed ORR was 23% (8/35; 95% CI 10% to 40%; one complete (CR), seven partial responses (PRs)) and clinical benefit rate (CR, PR, or stable disease ≥24 weeks) was 31% (11/35; 95% CI 17% to 49%). Median DOR was 9.7 months (95% CI 2.8 to not reached (NR)), median PFS was 2.8 months (95% CI 1.4 to 5.5), median OS was 14.8 months (95% CI 12.1 to NR), and 12-month OS was 75% (95% CI 55% to 86%). Immune phenotypic analyses and biomarker data revealed significantly higher FcγRIIIA+CD11c+ cells and higher programmed death-ligand 1 expression in responding patients, a strong association between T-cell infiltrated tumors and clinical benefit, and differences in immune architecture across histologic subtypes.","abstract":"$30","keywords":["Biomarker","Combination therapy","Immune Checkpoint Inhibitor","Immunotherapy","Ovarian Cancer"],"pubmed_id":"41436232","conclusions":"The BOT/BAL combination demonstrated deep, durable responses and complete remissions in patients with treatment-refractory ovarian cancer where no standard treatments are currently available. RECIST under-represented clinical benefit with 11 patients achieving prolonged/clinically meaningful stable disease (or better) for ≥24 weeks. Toxicities were manageable and reversible. The encouraging clinical activity of BOT/BAL in heavily pretreated patients, as well as biomarker associations, warrants further investigation of this combination.","publication_date":"2025-12-24T00:00:00"},"crossref":{"DOI":"10.1136/jitc-2025-013222","URL":"https://doi.org/10.1136/jitc-2025-013222","ISSN":["2051-1426"],"link":[{"URL":"https://syndication.highwire.org/content/doi/10.1136/jitc-2025-013222","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"e013222","type":"journal-article","issue":"12","score":1,"title":["Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab (anti–PD-1 antibody) in patients with treatment-refractory ovarian cancer"],"author":[{"given":"Rebecca","family":"Porter","sequence":"first","affiliation":[{"name":"Dana-Farber Cancer Institute, Boston, Massachusetts, USA"}]},{"given":"Bruno","family":"Bockorny","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"}]},{"given":"Bradley R","family":"Corr","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, Colorado, USA"}]},{"given":"Daruka","family":"Mahadevan","sequence":"additional","affiliation":[{"name":"The University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA"}]},{"given":"Breelyn A","family":"Wilky","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, Colorado, USA"}]},{"given":"Anthony B","family":"El-Khoueiry","sequence":"additional","affiliation":[{"name":"University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, USA"}]},{"given":"Andrea J","family":"Bullock","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"}]},{"given":"Navid","family":"Hafez","sequence":"additional","affiliation":[{"name":"The Angeles Clinic and Research Institute, Los Angeles, California, USA"}]},{"given":"Justin","family":"Moser","sequence":"additional","affiliation":[{"name":"HonorHealth Research Institute, Scottsdale, Arizona, USA"}]},{"given":"Anastasia","family":"Martynova","sequence":"additional","affiliation":[{"name":"University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, USA"}]},{"given":"Justin","family":"Stebbing","sequence":"additional","affiliation":[{"name":"Anglia Ruskin University, School of Life Sciences, Cambridge, England, UK"}]},{"given":"Bishnu","family":"Joshi","sequence":"additional","affiliation":[{"name":"Agenus Inc, Lexington, Massachusetts, USA"}]},{"given":"Sean","family":"Bourdelais","sequence":"additional","affiliation":[{"name":"Agenus Inc, Lexington, Massachusetts, USA"}]},{"given":"Chloe","family":"Delepine","sequence":"additional","affiliation":[{"name":"Agenus Inc, Lexington, Massachusetts, 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