Bristol Myers Advances Opdualag into Phase 3 Trials for First-Line Lung Cancer

Opdualag Expansion:
Bristol Myers Squibb is moving Opdualag, a LAG-3/PD-1 combination therapy, into phase 3 trials for first-line lung cancer treatment, specifically targeting stage IV non-small cell lung cancer (NSCLC) patients without prior systemic treatment in the metastatic setting.

Clinical Trial Design:
The phase 3 trial, known as Relativity-1093, will combine Opdualag with platinum chemotherapy and enroll patients with PD-L1 expression levels between 1-49%.

Previous Setbacks:
Opdualag faced setbacks in other cancer types, including colorectal, gastric, and liver cancers, which raised doubts about its potential beyond melanoma treatment.

Current Approval:
Opdualag is currently approved for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years of age or older.

Competitive Landscape:
The first-line NSCLC market is competitive, with other treatments like Keytruda (pembrolizumab) already established. The failure of Merck & Co’s rival anti-LAG3 MAb favezelimab in the Keytruda combo Keynote-495 trial has made the first-line NSCLC opportunity more significant for Opdualag.

ESMO Late-Breaker:
The phase 2 first-line NSCLC Relativity-104 study of Opdualag has been selected as an ESMO late-breaker, indicating promising results that could support the phase 3 trial.