BMS-986016

Bristol-Myers Squibb · Phase 2 active Small molecule Quality 20/100

BMS-986016 is a Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 2 development. Also known as: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab, Relatlimab.

BMS-986016 is a small molecule. It is being studied in clinical trials for various types of melanoma, including cutaneous melanoma, mucosal melanoma, ocular melanoma, stage III acral lentiginous melanoma, and stage IIIB cutaneous melanoma.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• 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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	BMS-986016
Also known as	Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab, Relatlimab
Sponsor	Bristol-Myers Squibb
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

• Fatigue
• Pruritus
• Arthralgia
• Diarrhoea
• Headache
• Nausea
• Rash
• Hypothyroidism
• Decreased appetite
• Anaemia
• Cough
• Asthenia

Key clinical trials

• Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer (PHASE2)
• Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma (PHASE2)
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
• Pan Tumor Rollover Study (PHASE2)
• Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study (PHASE2, PHASE3)
• Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (PHASE1)
• Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla (PHASE2)
• Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor (PHASE2)

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:

• BMS-986016 CI brief — competitive landscape report
• BMS-986016 updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI

Frequently asked questions about BMS-986016

What is BMS-986016?

BMS-986016 is a Small molecule drug developed by Bristol-Myers Squibb.

Who makes BMS-986016?

BMS-986016 is developed by Bristol-Myers Squibb (see full Bristol-Myers Squibb pipeline at /company/bristol-myers-squibb).

Is BMS-986016 also known as anything else?

BMS-986016 is also known as Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab, Relatlimab.

What development phase is BMS-986016 in?

BMS-986016 is in Phase 2.

What are the side effects of BMS-986016?

Common side effects of BMS-986016 include Fatigue, Pruritus, Arthralgia, Diarrhoea, Headache, Nausea.

Related

• Manufacturer: Bristol-Myers Squibb — full pipeline
• Also known as: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab, Relatlimab