Also known as: Opdivo Qvantig
Nivolumab is a programmed death receptor-1 (PD-1) blocking monoclonal antibody used across multiple cancers, including melanoma, lung cancer, renal cell carcinoma, head and neck cancer, urothelial carcinoma, gastrointestinal cancers, and mesothelioma. It is marketed as Opdivo and frequently used in monotherapy and combination regimens. The FDA first approved it on December 22, 2014.
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
Intravenous and subcutaneous nivolumab in advanced melanoma had similar safety profiles, with no major differences in systemic side effects. The main distinction was mild, manageable injection site reactions with subcutaneous administration.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
A 12-week supervised remote exercise program for patients with metastatic renal cell carcinoma undergoing immunotherapy showed significant improvements in health-related quality of life, fatigue, and symptom burden in a case series of 19 patients.
A Phase 1b/2 trial in 28 patients found nivolumab plus modified FOLFIRINOX was well tolerated before surgery in borderline-resectable pancreatic cancer. Seventy-nine percent proceeded to surgery, with complete tumor removal in all resected patients.
Studies in muscle-invasive bladder cancer found ctDNA predicted metastatic risk after bladder-sparing treatment, while urine tumor DNA was more sensitive for residual bladder disease. Data from RETAIN-2 and a PNAS study support molecular testing to help select patients for bladder preservation.
Bristol Myers Squibb said 2025 revenue was flat as a 17% increase in growth-portfolio sales offset a 15% decline in legacy drugs. The company expects legacy sales to fall another 12-16% in 2026, with newer products such as Opdivo, Reblozyl and Breyanzi supporting results.
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07576725 |
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572123 |
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07551583 |
Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07546812 |
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas |
RECRUITING | PHASE2 |
| NCT07541170 |
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07532902 |
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer |
RECRUITING | PHASE1 |
| NCT07529873 |
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07529613 |
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma |
COMPLETED | PHASE1/PHASE2 |
| NCT07527858 |
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07523763 |
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
