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Nivolumab and rHuPH20
Nivolumab and rHuPH20 is a PD-1 inhibitor with hyaluronidase enzyme Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development). Also known as: BMS-986298.
Nivolumab blocks PD-1 on immune cells to restore anti-tumor immunity, while rHuPH20 (recombinant human hyaluronidase) enhances drug penetration into tumors by degrading the hyaluronic acid-rich extracellular matrix.
Nivolumab blocks PD-1 on immune cells to restore anti-tumor immunity, while rHuPH20 (recombinant human hyaluronidase) enhances drug penetration into tumors by degrading the hyaluronic acid-rich extracellular matrix. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | Nivolumab and rHuPH20 |
|---|---|
| Also known as | BMS-986298 |
| Sponsor | Bristol-Myers Squibb |
| Drug class | PD-1 inhibitor with hyaluronidase enzyme |
| Target | PD-1; hyaluronic acid (via hyaluronidase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab is a PD-1 checkpoint inhibitor that prevents tumor cells from suppressing T-cell responses. rHuPH20 is an enzyme that breaks down hyaluronic acid in the tumor microenvironment, reducing physical barriers to drug and immune cell infiltration. This combination aims to improve nivolumab's efficacy by increasing its intratumoral concentration and facilitating immune cell access to cancer cells.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Fatigue
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Infusion reactions
- Rash
Key clinical trials
- Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (PHASE3)
- A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (PHASE3)
- An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (PHASE3)
- A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (PHASE2)
- A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nivolumab and rHuPH20 CI brief — competitive landscape report
- Nivolumab and rHuPH20 updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Nivolumab and rHuPH20
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Related
- Drug class: All PD-1 inhibitor with hyaluronidase enzyme drugs
- Target: All drugs targeting PD-1; hyaluronic acid (via hyaluronidase)
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
- Also known as: BMS-986298
- Compare: Nivolumab and rHuPH20 vs similar drugs
- Pricing: Nivolumab and rHuPH20 cost, discount & access