OpdualagAdvanced malignant melanoma - first-line
Development and Regulatory status
Phase III Clinical Trials
Recommended for approval (Positive opinion)
Jul 22Recommended for EU approval by CHMP for “the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression <1%”. Opdualag will be available as a 240 mg / 80 mg concentrate for solution for infusion .
Mar 22US approval was under the FDA’s Real-Time Oncology Review (RTOR) pilot program. The review was also conducted under the FDA’s Project Orbis initiative, which enabled concurrent review by the health authorities in Australia, Brazil and Switzerland, where the application remains under review .
Mar 22Approved by FDA the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma 
Mar 22Analysts consider relatlimab to have blockbuster potential as a first-in-class agent. Sales are anticipated to reach $437 in 2026 .
Oct 21EMA has validated MAA (Marketing Authorisation Application), confirming completion of the submission and beginning of EMA´s centralised review process. 
Sep 21US FDA accepts BLA for priority review, and assigns a PDUFA date of 19/3/22 .
Fixed dose combination of a programmed cell death-1 receptor (PDCD 1) inhibitor (nivolumab) plus a anti-lymphocyte activation gene-3 (anti-LAG-3) monoclonal antibody (relatlimab)
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population .
Advanced malignant melanoma - first-line
Trial or other data
Mar 21BMS reports that PII/III RELATIVITY-047 trial met its primary endpoint, progression-free survival. Assessment of overall survival is ongoing .
Sep 20PII/III study (NCT03470922) is still recruiting; collection of primary outcome data is now due to complete May 21 .
Dec 19PII/III study (NCT03470922) is recruiting; collection of primary outcome data is due to complete Jan 21 .
Apr 18PII/III study to determine whether first-line nivolumab in combination with relatlimab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread starts (NCT03470922). 700 patients aged 12 years or older will be recruited from sites around the world including the US & EU (plus UK). Primary outcome is progression-free survival and overall response rate; collection of these data is due to complete Jul 20 .
BMS reports that PII/III RELATIVITY-047 trial met its primary endpoint, progression-free survival. Assessment of overall survival is ongoing .