BMS’ Opdualag (nivolumab and relatlimab) Receives EC’s Approval as 1L Treatment for Unresectable or Metastatic Melanoma
Shots:
- The approval was based upon an exploratory analysis from the P-II/III (RELATIVITY-047) evaluating the fixed-dose combination of nivolumab (480mg) + relatlimab (160mg) vs nivolumab (480mg) alone in a ratio (1:1) in 714 patients aged 12yrs. with prior untreated metastatic or unresectable melanoma with tumor cell expression <1% across EU member states, Iceland, Liechtenstein & Norway
- The results showed an m-PFS (6.7mos. vs 3.0mos.), m-OS has not yet been reached, and the incidence of grade 3-5 adverse reactions was 43% vs 35%. The trial also met its 1EPs of PFS in the all-comer population & no new safety events were observed
- Opdualag is 1st approved LAG-3-blocking Ab combination for advanced melanoma in the EU
Ref: BMS| Image: BMS
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
