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NKTR-214
NKTR-214 is a Engineered cytokine; IL-2 receptor agonist Biologic drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Metastatic melanoma (in combination with nivolumab), Renal cell carcinoma (in combination with nivolumab), Non-small cell lung cancer (in combination with nivolumab). Also known as: Bempegaldesleukin, BMS-986321, CD122-Biased Cytokine, bempegaldesleukin.
NKTR-214 is an engineered interleukin-2 (IL-2) cytokine that preferentially activates and expands CD8+ T cells and NK cells to enhance anti-tumor immune responses.
NKTR-214, also known as bempegaldesleukin, is a protein-based experimental anti-cancer drug candidate. It is being studied in clinical trials for various cancer indications, including bladder cancer, melanoma, and renal cell carcinoma, often in combination with nivolumab.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | NKTR-214 |
|---|---|
| Also known as | Bempegaldesleukin, BMS-986321, CD122-Biased Cytokine, bempegaldesleukin, Bempegaldesleukin (BEMPEG) |
| Sponsor | Bristol-Myers Squibb |
| Drug class | Engineered cytokine; IL-2 receptor agonist |
| Target | IL-2 receptor (IL-2R); preferentially IL-2Rβγ over IL-2Rα |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
NKTR-214 is a modified IL-2 molecule designed to have reduced binding to the IL-2 receptor alpha (CD25) on regulatory T cells while maintaining activity on effector T cells and NK cells. This selective activation profile aims to promote anti-tumor immunity while minimizing immunosuppressive effects. It is typically used in combination with checkpoint inhibitors like nivolumab to enhance T cell proliferation and tumor infiltration.
Approved indications
- Metastatic melanoma (in combination with nivolumab)
- Renal cell carcinoma (in combination with nivolumab)
- Non-small cell lung cancer (in combination with nivolumab)
Common side effects
- Cytokine release syndrome
- Fatigue
- Pyrexia
- Nausea
- Immune-mediated adverse events
Key clinical trials
- A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma (PHASE2)
- A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma (PHASE3)
- A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer (PHASE3)
- Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PHASE1)
- Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma (PHASE2)
- A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 (PHASE1)
- A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread (PHASE1)
- Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (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:
- NKTR-214 CI brief — competitive landscape report
- NKTR-214 updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about NKTR-214
What is NKTR-214?
How does NKTR-214 work?
What is NKTR-214 used for?
Who makes NKTR-214?
Is NKTR-214 also known as anything else?
What drug class is NKTR-214 in?
What development phase is NKTR-214 in?
What are the side effects of NKTR-214?
What does NKTR-214 target?
Related
- Drug class: All Engineered cytokine; IL-2 receptor agonist drugs
- Target: All drugs targeting IL-2 receptor (IL-2R); preferentially IL-2Rβγ over IL-2Rα
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma (in combination with nivolumab)
- Indication: Drugs for Renal cell carcinoma (in combination with nivolumab)
- Indication: Drugs for Non-small cell lung cancer (in combination with nivolumab)
- Also known as: Bempegaldesleukin, BMS-986321, CD122-Biased Cytokine, bempegaldesleukin, Bempegaldesleukin (BEMPEG)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing