Drugs / Balstilimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | cervical carcinoma | 2021-04-19 | “The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer” agenusbio.com ↗ “A Biologics License Application has been submitted to the U.S. Food and Drug Administration for the use of balstilimab to treat recurrent/metastatic cervical cancer.” agenusbio.com ↗ “A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for the accelerated approval of balstilimab” agenusbio.com ↗ |
| Filed | US (FDA) | — | cervical carcinoma | 2020-09-18 | “rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for balstilimab alone” agenusbio.com ↗ |
Trials 53
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07128355 | May 2026 → Jan 2027 expected | metastasis from malignant tumor of colon | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT07193862 | Dec 2025 → Apr 2028 expected | colorectal cancer | Northwell Health | Recruiting | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT06411691 | Jun 2025 → Mar 2028 expected | colorectal cancer, malignant pancreatic neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 1 | NCT06336902 | Jan 2025 → Jan 2027 expected | colorectal adenocarcinoma | University of Southern California | Recruiting | No outcome recorded |
| Phase 1 | NCT06076837 | Jan → Dec 2025 | pancreatic adenocarcinoma | HonorHealth Research Institute | Terminated | No outcome recorded |
| Phase 1 | NCT06095674 | Jan 2024 → Jan 2026 | cervical cancer | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 1 | NCT05930951 | Nov 2023 → Oct 2024 | adenoid cystic carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Terminated | No outcome recorded |
| Phase 1 | NCT05377528 | Jul 2022 → Dec 2024 | neoplasm | Agenus Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04943848 | Jan 2022 → Sep 2026 overdue | diffuse midline glioma, H3 K27M-mutant | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT04156100 | Dec 2019 → Apr 2021 | neoplasm | Agenus Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03860272 | Mar 2019 → Jan 2025 overdue | angiosarcoma, cancer of unknown primary site, colorectal cancer, endometrial cancer +4 | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 1/27 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06782555 | Jan 2025 → Oct 2027 expected | head and neck squamous cell carcinoma, malignant pancreatic neoplasm, metastatic prostate carcinoma | ImmunoGenesis | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05318469 | Oct 2023 → Oct 2026 expected | triple-negative breast carcinoma | Yuan Yuan | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05672316 | May 2023 → Apr 2026 overdue | colorectal adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05627635 | May 2023 → Jun 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05205330 | Nov 2021 → Dec 2026 expected | colorectal cancer, gastric cancer | Rottapharm Biotech | Active not recruiting | Met primary |
| Phase 1/2 | NCT03495882 | Dec 2017 → Jul 2022 | cervical cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03104699 | Apr 2017 → Jun 2022 | cancer of unknown primary site, cervical cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 230 trials | ||||||
| Phase 2 | NCT07551596 | May 2027 → Aug 2029 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07516366 | May 2027 → Dec 2028 expected | clear cell renal carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07595874 | Dec 2026 → May 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07578337 | Jul 2026 → Feb 2029 expected | pancreatic neoplasm | Nelum Corp | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07550088 | Jun 2026 → Sep 2028 expected | colorectal cancer | Scripps Health | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07227636 | Nov 2025 → Nov 2030 expected | rectal carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06843551 | Jun 2025 → Aug 2030 expected | pancreatic ductal adenocarcinoma | Benjamin Spieler | Recruiting | No outcome recorded |
| Phase 2 | NCT06780787 | May 2025 → Nov 2027 expected | rectum adenocarcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06843434 | Feb 2025 → Feb 2028 expected | rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06589440 | Nov 2024 → Sep 2027 expected | colorectal cancer | Stingray Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT06268015 | Nov 2024 → Jul 2028 expected | colorectal cancer | Nicholas DeVito, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06575725 | Nov 2024 → Jan 2027 | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT06322108 | Jun 2024 → Apr 2030 expected | non-small cell lung carcinoma | Immune Oncology Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06300463 | Mar 2024 → Dec 2026 expected | metastasis from malignant tumor of colon | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT06251973 | Feb 2024 → Aug 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05864534 | Jan 2024 → Jul 2031 expected | IDH-wildtype glioblastoma, gliosarcoma | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05561491 | Jan 2024 → Jun 2027 | cutaneous melanoma | Targovax Oy | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05363709 | Oct 2023 → May 2026 | human papilloma virus infection, oropharynx cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05928806 | Sep 2023 → Nov 2026 | renal cell carcinoma | Michael B. Atkins, MD | Suspended | No outcome recorded |
| Phase 2 | NCT05891821 | Sep 2023 → Sep 2029 expected | lymphoma | Immune Oncology Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2027 expected | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05571293 | Mar 2023 → Nov 2024 | colorectal neoplasm | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT05638698 | Dec 2022 → Dec 2024 overdue | neoplasm | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05529316 | Dec 2022 → Feb 2028 expected | melanoma | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05608044 | Nov 2022 → Sep 2027 expected | colorectal cancer | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05033132 | Oct 2021 → Dec 2024 | cervical cancer | Agenus Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04607200 | Feb → Sep 2021 | angiosarcoma | Agenus Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04430036 | Oct 2020 → Oct 2021 | urinary bladder cancer | The University of Texas Health Science Center at San Antonio | Terminated | No outcome recorded |
| Phase 2 | NCT04028063 | Jan 2020 → Apr 2027 expected | soft tissue sarcoma | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03894215 | Jun 2019 → Mar 2025 | cervical cancer | Agenus Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06279130 | Jan 2024 → Jan 2029 expected | — | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07152821 | Mar → Jul 2026 | colorectal cancer | Canadian Cancer Trials Group | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT06346197 | Dec 2025 → May 2028 expected | gastric cancer, metastatic malignant neoplasm | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 3 | NCT04943627 | Aug → Oct 2021 | cancer of unknown primary site, cervical cancer | Agenus Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase not stated1 trial | ||||||
| — | NCT05572970 | — | cancer | Agenus Inc. | Available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT06782932 Background | May 2025 → Dec 2028 expected | pancreatic adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| — | NCT06751524 Background | — | colorectal cancer, hepatocellular carcinoma, malignant pancreatic neoplasm, melanoma +4 | Agenus Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 78
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Agenus Inc. | Regulatory Armenia Grants First Marketing Authorizations for Agenus’ BOT+BAL in Previously Treated MSS Metastatic Colorectal Cancer agenusbio.com ↗
These are the first marketing authorizations for either medicine anywhere in the world. |
| 2026-10-03 | Agenus Inc. | Results Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 2026 agenusbio.com ↗
Among patients evaluable for efficacy, three-year overall survival was 48% (n=35), unchanged from the two-year estimate, suggesting durable clinical benefit in this population. |
| 2026-08-28 | Agenus Inc. | Results Agenus Announces Peer-Reviewed Publication Linking BOT+BAL’s Durable Survival in MSS Metastatic Colorectal Cancer to Its Distinct Immune-Priming Mechanism agenusbio.com ↗
Mature 123 patient analysis reports 21.2-month median overall survival and 33% three-year overall survival in heavily pretreated MSS mCRC without active liver metastases |
| 2026-08-26 | Agenus Inc. | Results Agenus Announces Updated NEST Phase 2 Publication Reporting Deep Pathologic Responses and No Observed Recurrences with Neoadjuvant BOT+BAL in Resectable Colon Cancer agenusbio.com ↗
At the March 31, 2026 data cutoff, no colorectal cancer recurrences had been observed, with median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. |
| 2026-07-06 | Agenus Inc. | Results Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026 agenusbio.com ↗
With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years. |
| 2026-05-21 | Agenus Inc. | Results Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRC agenusbio.com ↗
In a retrospective analysis of refractory MSS metastatic colorectal cancer without active liver metastases, the AI-identified subgroup had a 64% response rate to BOT+BAL, compared with 9% in the remaining cohort |
| 2026-05-21 | Agenus Inc. | Results Agenus Presents Phase 2 BOT+BAL Melanoma Data Showing Durable Responses and Meaningful Survival in Advanced Checkpoint-Refractory Melanoma at ASCO 2026 agenusbio.com ↗
In the overall BOT+BAL population, median overall survival was 16.6 months, 42% of patients were alive at two years, and median duration of response was not reached. |
| 2026-05-15 | Agenus Inc. | Results Agenus Announces Publication of Phase 1b Botensilimab and Balstilimab Data in Post-Immunotherapy Hepatocellular Carcinoma in Liver Cancer agenusbio.com ↗
Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate (ORR) of 17%, including one complete response and two partial responses. |
| 2026-04-17 | Agenus Inc. | Results Agenus Reports Phase II Data Demonstrating Immune Reprogramming and Durable Survival with Botensilimab, Balstilimab and agenT-797 in PD-1 Refractory Gastroesophageal Cancer agenusbio.com ↗ |
| 2026-02-19 | Agenus Inc. | Results Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BAL agenusbio.com ↗
Integrating blood-based inflammatory markers with tumor immune features improved overall survival stratification in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to conventional checkpoint inhibitors. |
| 2026-01-12 | Agenus Inc. | Regulatory France Expands National AAC Access for Agenus' Botensilimab + Balstilimab for Ovarian Cancer and Soft-Tissue Sarcomas agenusbio.com ↗
Agenus Inc . ( Nasdaq: AGEN ), a leader in immuno-oncology innovation, today announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balst |
| 2025-12-23 | Agenus Inc. | Results Agenus Reports Deep, Durable Responses with Botensilimab + Balstilimab in Highly Refractory Ovarian Cancer, Published in JITC agenusbio.com ↗
In this heavily pretreated population, BOT+BAL demonstrated clinically meaningful activity and durable benefit in women with treatment-refractory ovarian cancer, a population with few remaining options. |
| 2025-10-17 | Agenus Inc. | Results Agenus Reports 39% of Patients Alive at Two-Years with BOT/BAL Across Multiple Refractory Solid Tumors at ESMO 2025 agenusbio.com ↗
“With longer follow up, we’re finding that approximately 40% of patients with very limited survival expectation are alive at two years,” said Michael S. Gordon, MD, HonorHealth Research Institute. |
| 2025-09-09 | Agenus Inc. | Regulatory France Grants Reimbursed Compassionate Access (AAC) for Agenus’ BOT/BAL in Refractory MSS Metastatic Colorectal Cancer agenusbio.com ↗
Agenus Inc. (Nasdaq: AGEN), a leader in immuno‑oncology, today announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, or AAC) framework. |
| 2025-07-07 | Agenus Inc. | Results Agenus’ BOT/BAL Achieves 42% Two-Year Survival in Refractory MSS CRC, Advances Toward Registration with FDA Alignment on Phase 3 agenusbio.com ↗
Notably, median overall survival (OS) reached 20.9 months, with 42% of patients still alive at two years in this refractory population. |
| 2025-05-30 | Rottapharm Biotech | Results Phase I/II study of vorbipiprant combined with anti-PD-1 immunotherapy results in metastatic gastrointestinal non-colorectal cancers presented at ASCO 2025 rottapharmbiotech.com ↗
Vorbipiprant combined with PD-1 blockade was well tolerated and showed signs of activity in non-colorectal GI cancers, thus confirming a broader spectrum of activity, on top of the results obtained in MSS mCRC. |
| 2025-04-28 | Agenus Inc. | Results Agenus’ BOT/BAL Neoadjuvant Pan-Cancer Data from the NEOASIS Study Presented in an Oral Session at AACR agenusbio.com ↗
These initial results from the NEOASIS study indicate that botensilimab and balstilimab can induce pathological responses in patients with a variety of solid tumors, including triple-negative breast cancer, after just two doses, |
| 2025-04-25 | Agenus Inc. | Results Agenus’ BOT/BAL Data in Pretreated Liver Cancer Presented at AACR 2025 agenusbio.com ↗
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced updated data from the hepatocellular carcinoma (HCC) cohort of its ongoing Phase 1 study evaluating botensilimab (BOT) in combination with balstilimab (BAL). |
| 2025-02-26 | Agenus Inc. | Results Agenus Reports Impact of Key Immuno-Oncology Data Presented at Leading Medical Conferences and Peer-Reviewed Publications agenusbio.com ↗
The combination targets complementary pathways and has demonstrated clinical responses across nine tumor types, including those historically considered immuno-oncology (IO) "cold" tumors or resistant to prior IO treatments. |
| 2025-02-24 | MiNK Therapeutics | Results MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting minktherapeutics.com ↗
The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastroesophageal cancer (NCT06251973). |
| 2025-02-24 | Agenus Inc. | Results Agenus Presents New Botensilimab/Balstilimab Data in Gastric Cancer at AACR IO Annual Meeting agenusbio.com ↗
The addition of MiNK’s allogeneic iNKT therapy, agenT-797, to BOT/BAL drove robust immune activation, including elevated interferon-gamma (IFNγ) levels, indicating potent systemic engagement and overcoming immunosuppressive pathways in PD-1–refractory gastric tumors. |
| 2025-01-29 | Agenus Inc. | Results Agenus Announces Publication in the Journal of Clinical Oncology Highlighting Data from Botensilimab Plus Balstilimab in Relapsed/Refractory Metastatic Sarcomas agenusbio.com ↗
These findings highlight the ability of this combination to deliver meaningful clinical benefits, including durable responses and extended survival, for patients who previously had very limited treatment options. |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
BOT75/BAL achieved a 19% ORR and 55% disease control rate (DCR) in this refractory population. |
| 2024-12-02 | Rottapharm Biotech | Results Vorbipiprant combined with PD-1 blockade for refractory microsatellite stable metastatic colorectal cancer phase I/II trial results published in Clinical Cancer Research rottapharmbiotech.com ↗
The combination achieved a disease control rate (DCR) of 50% across the entire cohort, and a notable DCR of 25% in the subgroup of patients with liver metastases, that are usually refractory to immunotherapy approaches. |
| 2024-09-13 | Agenus Inc. | Results Botensilimab/Balstilimab Clinical Responses in Refractory Sarcomas Presented at ESMO 2024 agenusbio.com ↗
The data from a Phase 1 study of botensilimab (BOT), an investigational Fc-enhanced CTLA-4 inhibitor, in combination with balstilimab (BAL), an investigational PD-1 antibody, showed clinical activity in patients with refractory sarcomas, a population with limited treatment options. |
| 2024-07-18 | Agenus Inc. | Regulatory Agenus Announces End-of-Phase-2 Meeting Outcomes and Topline Interim Phase 2 Data for BOT/BAL in MSS Colorectal Cancer agenusbio.com ↗
FDA advised against submission of these results in support of an Accelerated Approval based on their view that objective response rates may not translate to survival benefit. |
| 2024-06-28 | Agenus Inc. | Results Significant Tumor Reductions in Neoadjuvant MSS Colon Cancer Patients Treated with Botensilimab/Balstilimab Presented at ESMO GI Conference agenusbio.com ↗
In the NEST-2 cohort, 78% (7/9) of MSS patients achieved pathologic responses of at least 50% tumor regression, with 56% (5/9) reaching complete pathologic responses. |
| 2024-06-13 | Agenus Inc. | Results Nature Medicine Reports Agenus’ Novel Immunotherapy Demonstrates Clinical Activity Against a Deadly Form of Colorectal Cancer on the Rise in Americans Under 50 agenusbio.com ↗
Agenus has published results from a groundbreaking clinical trial in Nature Medicine , revealing the potential of a novel immunotherapy combination for treating microsatellite stable metastatic colorectal cancer (MSS mCRC), a cancer type historically resistant to immunotherapy. |
| 2024-05-31 | Rottapharm Biotech | Results Updated results and subgroup analysis of the phase I/II study of CR6086 (vorbipiprant) and balstilimab in advanced colorectal cancer presented at ASCO 2024 rottapharmbiotech.com ↗
The analysis indicates that vorbipiprant combined with an anti-PD-1 showed promising efficacy also in patients with liver metastases |
| 2024-05-23 | Agenus Inc. | Results Breakthrough Data on Botensilimab/Balstilimab in MSS CRC Presented at the 2024 ASCO Annual Meeting agenusbio.com ↗
The analysis shows that BOT/BAL is active in metastatic sites beyond the lungs and lymph nodes, including the peritoneum, soft tissue, and brain, which have historically been unresponsive to treatment. |
| 2024-01-22 | Agenus Inc. | Results Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population agenusbio.com ↗
The study achieved durable elimination of ctDNA, a critical biomarker for cancer clearance and long-term disease-free survival |
| 2023-10-23 | Rottapharm Biotech | Results Rottapharm Biotech discloses at ESMO 2023 favourable results from the Phase 1/2 study of the EP4 receptor antagonist CR6086 combined with the anti-PD-1 balstilimab in advanced colorectal cancer rottapharmbiotech.com ↗
Rottapharm Biotech announces favourable clinical results of CR6086, its potent and selective small molecule antagonist of the prostaglandin EP4 receptor, combined with the anti PD-1 antibody balstilimab (Agenus Inc, Nasdaq: AGEN) in advanced colorectal cancer (CRC). |
| 2023-10-22 | Agenus Inc. | Results Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma agenusbio.com ↗
“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer. |
| 2023-10-21 | Agenus Inc. | Results ESMO 2023: Agenus’ Botensilimab/Balstilimab Combination Delivers Durable Responses across Multiple Sarcoma Subtypes agenusbio.com ↗
As the study has advanced, BOT+BAL continues to demonstrate encouraging results in a larger population of patients with difficult to treat sarcomas, with a median response duration of 19.4 months and a 40% 6-month progression-free survival rate. |
| 2023-06-30 | Agenus Inc. | Results ESMO GI Data: Agenus' Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer agenusbio.com ↗
The new data show substantial survival benefits and long-lasting responses for patients with non-MSI-H (microsatellite stable or non-microsatellite instability-high) metastatic colorectal cancer previously resistant to chemotherapy and/or immunotherapy. |
| 2023-04-17 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer agenusbio.com ↗
The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. |
| 2023-03-27 | Agenus Inc. | Results Agenus’ Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer agenusbio.com ↗
These findings, presented in an oral plenary session at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer, showed a 33% overall response rate (ORR). |
| 2023-01-23 | Agenus Inc. | Results Agenus Presents Clinical Data Demonstrating Durable Responses of Botensilimab/Balstilimab Combination in Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI agenusbio.com ↗
The larger dataset continues to demonstrate that this combination offers superior efficacy and durability compared to what has been reported for standard of care and other investigational therapies in third line metastatic MSS CRC. |
| 2022-11-17 | Agenus Inc. | Results Agenus Data at CTOS 2022 Highlight Durable Clinical Responses of Botensilimab / Balstilimab Combination in Advanced Sarcoma agenusbio.com ↗
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 advanced sarcoma. |
| 2022-11-14 | Agenus Inc. | Results Agenus Data at SITC 2022 Highlight Durable Responses of Botensilimab / Balstilimab Combination in Nine Different Treatment-Resistant Cancers agenusbio.com ↗ |
| 2022-06-29 | Agenus Inc. | Results Agenus Shows Unprecedented Activity for Botensilimab/Balstilimab Combination in Microsatellite Stable Colorectal Cancer at ESMO World GI Congress agenusbio.com ↗
The data demonstrate that the combination offers strong durability and superior efficacy than what has been reported in separate trials for standard of care and other investigational therapies in 2L+ MSS CRC. |
| 2021-12-22 | Agenus Inc. | Results Balstilimab Plus Zalifrelimab Data Published in Journal of Clinical Oncology (JCO) agenusbio.com ↗
The trial showed that in the 125 evaluable patients treated with Bal/Zal, ORR was 25.6%; among PD-L1+ patients, the ORR was 32.8%. |
| 2021-11-12 | Agenus Inc. | Results Clinical Activity of AGEN1181 Demonstrated Across Nine Treatment-Resistant Cancers at SITC agenusbio.com ↗ |
| 2021-11-09 | Agenus Inc. | Regulatory Agenus Corporate Update and Third Quarter 2021 Financial Report agenusbio.com ↗
BLA for balstilimab in second-line cervical cancer was withdrawn after full approval of pembrolizumab, four months ahead of the FDA goal date, based on data for pembrolizumab plus chemotherapy in first-line setting |
| 2021-10-22 | Agenus Inc. | Regulatory Agenus Provides Update on Balstilimab Development agenusbio.com ↗
today announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. |
| 2021-09-16 | Agenus Inc. | Results Combination of Balstilimab Plus Zalifrelimab Doubles Responses in 2L Cervical Cancer in Data to Be Presented at ESMO agenusbio.com ↗
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 |
| 2021-08-26 | Agenus Inc. | Results Balstilimab Monotherapy Data Published in Gynecologic Oncology agenusbio.com ↗
In the 140 evaluable patients, the objective response rate (ORR) in patients with PD-L1 positive tumors was 20.0% and included 3 patients (3/85, 3.5%) with a complete response and 14 patients (14/85, 16.5%) with a partial response. |
| 2021-07-30 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业CTLA-4抗体联合PD-1抗体治疗晚期宫颈癌获批开展临床试验 bettapharma.com ↗
治疗晚期宫颈癌的临床试验已获得国家药品监督管理局批准开展。 |
| 2021-07-15 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业PD-1 抗体和CTLA-4 抗体联用治疗晚期实体瘤获批开展临床试验 bettapharma.com ↗
7月15日，贝达药业收到国家药品监督管理局签发的《药品临床试验批准通知书》 （通知书编号：2021LP01044、2021LP01052），由公 司和 Agenus Inc. (以下简称“Agenus”)共同申报的巴替利单抗注射液 (Balstilimab，PD-1 抗体)和泽弗利单抗注射液(Zalifrelimab，CTLA-4 抗体)联用治疗晚期实体瘤的两项药品临床试验已获得国家药品监督管理局批准开展。 |
| 2021-06-17 | Agenus Inc. | Regulatory Agenus Announces U.S. FDA Acceptance and Priority Review of Balstilimab Biologics License Application for the Treatment of Recurrent or Metastatic Cervical Cancer agenusbio.com ↗
The FDA has granted Priority Review to this submission, a designation for drugs which, if approved, may provide significant improvements in the safety or effectiveness of the treatment of serious conditions. |
| 2021-06-10 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业巴替利单抗（PD-1抗体）注射液获批开展临床试验 bettapharma.com ↗
巴替利单抗注射液（Balstilimab，PD-1抗体）单独或联合泽弗利单抗注射液（Zalifrelimab，CTLA-4抗体）治疗晚期宫颈癌的临床试验已获得国家药品监督管理局批准。 |
| 2021-06-04 | Agenus Inc. | Results Agenus’ Presentations at ASCO 2021 Demonstrate Differentiated Activity of Balstilimab and Provide Clinical Update on AGEN2373 agenusbio.com ↗
Balstilimab showed superior tumor killing in both PD-L1 positive and PD-L1 negative tumors compared to commercially available anti-PD-1 antibodies in these studies. |
| 2021-05-20 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业CTLA-4抗体联合PD-1抗体治疗晚期宫颈癌药品临床试验申请获受理 bettapharma.com ↗
由公司和Agenus Inc.（以下简称“Agenus”）共同申报的泽弗利单抗注射液（Zalifrelimab，CTLA-4抗体）联合巴替利单抗注射液（Balstilimab，PD-1抗体）治疗晚期宫颈癌的药品临床试验申请已获得国家药品监督管理局受理。 |
| 2021-05-20 | Agenus Inc. | Results Agenus Presents New Data on Balstilimab and AGEN2373 in ASCO Abstracts agenusbio.com ↗
Balstilimab has shown expanded clinical activity in a Phase 2 clinical trial for patients with recurrent or metastatic cervical cancer. |
| 2021-05-06 | Agenus Inc. | Regulatory Agenus Corporate Update and First Quarter 2021 Financial Report agenusbio.com ↗
A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for the accelerated approval of balstilimab for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| 2021-04-28 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业PD-1抗体和CTLA-4抗体联用药品临床试验申请获受理 bettapharma.com ↗
由公司和 Agenus Inc. (以下简称“Agenus”)共同申报的巴替利单抗注射液 (Balstilimab，PD-1 抗体)和泽弗利单抗注射液(Zalifrelimab，CTLA-4 抗体)联用治疗晚期实体瘤的两项药品临床试验申请已获得国家药品监督管理局受理。 |
| 2021-04-19 | Agenus Inc. | Regulatory Agenus Submits Balstilimab Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer agenusbio.com ↗ |
| 2021-04-10 | Agenus Inc. | Results New Clinical Responses for AGEN1181 Presented at AACR agenusbio.com ↗
In addition, as the clinical data matures, additional responses as well as a conversion from a partial response to a complete response, have been observed. |
| 2021-02-09 | Agenus Inc. | Results Agenus Announces New Responses for AGEN1181 agenusbio.com ↗
The trial has also defined the optimal combination dose for AGEN1181 +/- balstilimab. |
| 2020-12-01 | Agenus Inc. | Results Agenus Launches Phase 2 Trial Expansion in Colon Cancer for AGEN1181 in Combination with Balstilimab agenusbio.com ↗
With this recent response in colon cancer, AGEN1181 +/- balstilimab (anti-PD-1) has reported 4 clinical responses plus a significant tumor reduction of more than 27% in a fifth patient. |
| 2020-11-09 | Agenus Inc. | Results Agenus Presents Additional Clinical Responses and Novel Biomarker Data at SITC2020 agenusbio.com ↗
AGEN1181 (Fc-enhanced CTLA-4) +/- balstilimab ( Agenus’ anti-PD-1) show s additional clinical responses in tumors which are “biomarker unlikely” to respond; |
| 2020-10-22 | Recepta Biopharma | Results Imunoterápicos Recepta / Agenus: opções promissoras para o tratamento de câncer uterino. receptabio.com.br ↗
Os resultados de dois ensaios de fase II independentes indicaram que o balstilimabe (AGEN2034, inibidor PD-1) em monoterapia ou em combinação com o zalifrelimabe (AGEN1884, inibidor CTLA-4) demonstrou taxas de resposta objetiva (TRO) promissoras, independentemente da expressão de PD-L1, e um perfil de segurança tolerável nesse perfil de pacientes. |
| 2020-09-18 | Agenus Inc. | Results Agenus Presents Results from Two Large Cervical Cancer Trials at ESMO agenusbio.com ↗ |
| 2020-09-18 | Agenus Inc. | Regulatory Agenus Initiates Rolling BLA Submission of Balstilimab for Recurrent/Metastatic Cervical Cancer agenusbio.com ↗ |
| 2020-05-29 | Agenus Inc. | Results ASCO Presentation of Agenus' AGEN1181 by Dr. Steven O'Day agenusbio.com ↗ |
| 2020-05-07 | Agenus Inc. | Results Agenus First Quarter Results and Update agenusbio.com ↗
Balstilimab + Zalifrelimab (anti-CTLA-4) achieve 26% response rates in a cohort of 55 patients with advanced cervical cancer |
| 2020-04-07 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer agenusbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer. |
| 2020-03-21 | Recepta Biopharma | Results Balstilimab e zalifrelimab são promissores para o tratamento de câncer de colo do útero. receptabio.com.br ↗
Agenus announced early data supporting its two lead immunotherapy candidates — balstilimab and zalifrelimab — for the second-line treatment of advanced cervical cancer that responded poorly to platinum chemotherapy. |
| 2020-03-12 | Agenus Inc. | Results Agenus Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update agenusbio.com ↗
Updated data of balstilimab & zalifrelimab show 26.5% objective response rates which are durable in an all-comer, non-biomarker selected population of patients with refractory cervical cancer |
| 2020-03-12 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer agenusbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer. |
| 2020-02-20 | Agenus Inc. | Results Agenus Announces Positive Interim Data from Balstilimab and Zalifrelimab Clinical Trials in Second-Line Cervical Cancer agenusbio.com ↗
The interim analysis from 44 evaluable patients treated with balstilimab monotherapy demonstrated an ORR of 11.4% in second-line cervical cancer. |
| 2018-12-21 | Recepta Biopharma | Results Imunoterapia em desenvolvimento: dados promissores em câncer de colo uterino. receptabio.com.br ↗ |
| 2018-10-20 | Agenus Inc. | Results Agenus Presents Clinical Data on Its PD-1 & CTLA-4 at ESMO 2018 agenusbio.com ↗
Patients treated with AGEN2034 reveal a clinical benefit rate of 68% in evaluable patients with metastatic and/or locally advanced solid tumors, and in 3 of 7 evaluable patients with refractory cervical cancer. |
| 2018-10-09 | Agenus Inc. | Results Agenus To Present Data on Proprietary CTLA-4 & PD-1 Antibodies at ESMO 2018 agenusbio.com ↗
AGEN PD-1 antibody (AGEN2034) shows early signs of clinical activity in patients with cervical cancer |
| 2018-06-04 | Agenus Inc. | Results Agenus Presents Clinical Responses of AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1) at ASCO 2018 agenusbio.com ↗
Clinical benefit was observed in 31% and 42% of evaluable patients, respectively. |
| 2018-05-17 | Agenus Inc. | Results Agenus to Present Clinical Data on Lead Programs at ASCO 2018 agenusbio.com ↗
AGEN1884 (CTLA-4) and AGEN2034 (PD-1) show objective clinical responses |
| 2017-11-09 | Agenus Inc. | Results Agenus To Present on Lead Antibody Programs AGEN1884 (CTLA-4) and AGEN2034 (PD-1) at SITC 2017 agenusbio.com ↗ |
| 2017-03-07 | Agenus Inc. | Results Four Agenus Abstracts Accepted for Presentation at the American Association for Cancer Research (AACR) 2017 Annual Meeting agenusbio.com ↗
Data presentations will highlight how Agenus' clinical-stage CTLA-4 antagonist (AGEN1884) effectively combines with its PD-1 antagonist (AGEN2034) and other antibodies targeting the PD-1/PD-L1 axis to promote superior T cell immune responses compared to monotherapy approaches. |
All press releases naming this drug 97 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | balstilimab | “AGEN2034 (balstilimab) is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block programmed cell death 1 (PD-1) from interacting with its ligands (PD-L)...” NCT05205330 ↗49“SR-8541A administered orally in combination with intravenous botensilimab and balstilimab” NCT06589440 ↗ “Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL).” NCT06751524 ↗ “Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.” NCT05318469 ↗ “Balstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.” NCT07578337 ↗ |
| Known as | AGEN2034 | “Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)” NCT05572970 ↗ |
| Known as | BAL | “Balstilimab (BAL)” NCT04943627 ↗ |
| Action | Inhibit | “balstilimab (BAL; anti-PD-1 antibody)” PMID 38871975 ↗ Jun 2024 |
| Modality | Monoclonal antibody | “Anti-programmed cell death protein-1 (PD-1) Monoclonal Antibody” NCT03104699 ↗ |
| Route | Intravenous | “intravenous (IV)” NCT03104699 ↗ |
| Target | PDCD1 | “Balstilimab (AGEN2034) is a human monoclonal antibody that targets programmed cell death 1 (PD-1).” NCT04028063 ↗ |