Bristol Myers Squibb Advances Opdualag to Phase 3 Trials for Non-Small Cell Lung Cancer

Bristol Myers Squibb Advances Opdualag to Phase 3 Trials for Non-Small Cell Lung Cancer

Bristol Myers Squibb (BMS) is set to push its PD-1/LAG-3 combination therapy, Opdualag, into phase 3 trials for first-line non-small cell lung cancer (NSCLC), two years after its initial FDA approval in melanoma. The registrational trial, named RELATIVITY1093, will evaluate Opdualag, a combination of the PD-1 inhibitor Opdivo and the LAG-3 inhibitor relatlimab, plus chemotherapy, in advanced nonsquamous NSCLC cases with PD-L1 expression between 1% and 49%.

This phase 3 trial will explore a higher dosage of relatlimab compared to the melanoma indication, with Merck & Co.’s Keytruda and chemotherapy serving as the control. Additionally, BMS plans another phase 3 trial next year for NSCLC patients with PD-L1 expressions of 50% or higher.

**Rationale Behind the Trial**

Samit Hirawat, M.D., BMS’s Chief Medical Officer, highlighted the unmet medical needs in the PD-L1-low population. He noted that the current standard treatments do not provide the progression-free survival and overall response rate benefits seen in the company’s clinical trials.

**Insights from RELATIVITY-104**

BMS’s decision is informed by phase 2 results from the RELATIVITY-104 trial, which tested the Opdualag regimen in stage 4 or recurrent NSCLC without PD-L1 expression restrictions. The trial showed positive outcomes in PD-L1-positive and nonsquamous patients, but less benefit in squamous patients. Among PD-L1-low patients, the Opdualag-chemo group demonstrated an overall response rate (ORR) of 60.7% and a median progression-free survival (PFS) of 9.8 months, compared to 30% ORR and 5.5 months PFS in the Opdivo-chemo group.

**Competition and Future Outlook**

The lung cancer treatment landscape is evolving, with multiple companies, including Merck, AstraZeneca, and Gilead Sciences, working on similar combination therapies. Despite this competition, BMS remains optimistic, viewing each trial as a learning opportunity for advancing cancer treatment options.

BMS’s efforts to refine the trial design for PD-L1-high patients reflect their commitment to understanding the complexities of lung cancer treatment and improving patient outcomes.