Bristol Myers Squibb announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen.

The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community. Opdivo and Opdivo-based combinations have shown positive outcomes and are approved treatment options for eligible patients with resectable or metastatic NSCLC. CheckMate -73L is a Phase 3 randomized, open label trial evaluating Opdivo in combination with concurrent chemoradiotherapy (CCRT), followed by Opdivo plus Yervoy, or Opdivo (monotherapy), compared to CCRT alone followed by durvalumab, in patients with previously untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery.

A total of 925 patients were randomized to receive specified doses on specified days of either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo in combination with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C). The primary endpoint of the trial is progression-free survival (PFS) by RECIST 1.1 per blinded independent central review (BICR) for Arm A vs. Arm C. Secondary endpoints include overall survival (OS) across the study arms, PFS by RECIST 1.1 per BICR across the study arms, as well as objective response rate (ORR), time to response (TTR) and duration of response (DOR) per RECIST 1.1 per BICR, and additional safety and efficacy endpoints.