Relatlimab Approved Naked monospecific

Antibody Information

Entry ID	39
INN	Relatlimab
Status	Approved
Drug code(s)	BMS-986016, ONO-4482
Brand name	Opdualag (relatlimab + nivolumab combo)
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	LAG-3
Indications of clinical studies	Multiple myeloma, melanoma, gastric cancer, colorectal cancer, glioblastoma, non-small cell lung cancer, solid tumors, Chronic lymphocytic leukemia and lymphomas
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 15, 2013
Start of Phase 2	May 15, 2016
Start of Phase 3	April 10, 2018
Date BLA/NDA submitted to FDA	July 19, 2021
Year of first approval (global)	2022
Date of first US approval	March 18, 2022
INN, US product name	Relatlimab, relatlimab-rmbw
US or EU approved indications	US: First approval for Melanoma (OPDUALAG is a combination of nivolumab and relatlimab indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.) (as of first label and March 6, 2024 label). EU: First approval for Melanoma (OPDUALAG is indicated for the first-line treatment of advanced (unresedctable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.) (as per EPAR - Product Information last updated on January 6, 2025).

Company information

Company	Bristol-Myers Squibb
Licensee/Partner	Ono
Comments about company or candidate	Approved in EU on Sep 15, 2022 Sep 20, 2021: Bristol Myers Squibb announced that FDA has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. NCT03470922 Phase 2/3 in melanoma started recruiting in April 2018 still recruiting as of last update in Sep 2020. NCT04150965 Phase 1/2 in MM not yet recruiting as of Nov 5, 2019. Nine Phase 2 studies sponsored by BMS recruiting as of Aug 2019. NCT02061761 Phase 1 study in NHL, CLL, HL started in Feb 2014. BMS has joint development/commercialization deal with Ono Phase 1 NCT01968109 as monotherapy or combination therapy with nivolumab started in Oct 2013.
Full address of company	Route 206 & Province Line Road Princeton, New Jersey 08543 North America United States of America https://www.bms.com/about-us/contact-us.html

Description/comment

Immune checkpoint target. Combination of Relatlimab + Nivolumab is BMS-986213

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None