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.
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.
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.
The FDA has approved nivolumab with chemotherapy for pediatric and adult Hodgkin lymphoma patients aged 12+, based on clinical trial data showing improved survival. Separately, the agency cleared investigational new drug applications for FG001 for brain cancer surgery visualization and FRF-001 gene therapy for FOXG1 syndrome, allowing both to proceed to clinical trials.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Scientists at Cincinnati Children's have identified a molecular pathway responsible for immune checkpoint inhibitor-induced myocarditis and demonstrated that blocking TNF signaling can prevent this fatal complication without compromising anti-tumor efficacy.
Decreases in circulating tumor DNA within 3-4 weeks of immune checkpoint inhibitor therapy were strongly associated with higher response rates and longer survival in patients with unresectable stage III/IV melanoma, according to a multi-institutional retrospective analysis.
Two recent clinical trials found that adding immunotherapy to standard chemoradiation did not improve survival for patients with limited-stage small-cell lung cancer or high-risk HPV-positive oropharyngeal cancer, though both studies revealed important insights about treatment delivery and radiation scheduling.
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07476326 |
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07176650 |
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma |
RECRUITING | PHASE1 |
| NCT06640530 |
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06304597 |
Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy |
NOT_YET_RECRUITING | PHASE1 |
| NCT06112808 |
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT05004025 |
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma |
COMPLETED | PHASE1 |
| NCT04875611 |
Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment |
RECRUITING | PHASE2 |
| NCT04627012 |
Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma |
COMPLETED | |
| NCT03245021 |
Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT03181308 |
Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC |
COMPLETED | PHASE1 |
