Opdivo Fails to Meet Primary Endpoint in CheckMate-73L NSCLC Study

Key Insights

• Bristol Myers Squibb's CheckMate-73L study, evaluating Opdivo plus Yervoy following chemoradiotherapy, did not meet its primary endpoint of progression-free survival in unresectable stage III NSCLC.
• The phase III trial compared Opdivo-based regimens to chemoradiotherapy followed by AstraZeneca’s Imfinzi in 925 patients with locally advanced non-small cell lung cancer.
• No new safety signals were identified, with adverse events consistent with the known profiles of Opdivo and Yervoy, according to Bristol Myers Squibb.

Bristol Myers Squibb (BMY) recently announced that the phase III CheckMate-73L study, designed to expand the label for its cancer drug combination Opdivo (nivolumab) and Yervoy (ipilimumab), failed to meet the primary endpoint of progression-free survival (PFS) in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). The trial's results represent a setback for Bristol Myers in its efforts to enhance treatment options for this patient population.

The CheckMate-73L study involved 925 patients with unresectable stage III NSCLC, randomized into three arms. Arm A received Opdivo in combination with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy. Arm B received Opdivo in combination with CCRT followed by Opdivo monotherapy. Arm C, the comparator arm, received CCRT followed by durvalumab (AstraZeneca’s Imfinzi).

The study's secondary endpoints included overall survival (OS), objective response rate (ORR), time to response (TTR), duration of response (DOR), and additional safety and efficacy measures. While the primary endpoint was not met, Bristol Myers reported that the safety profile observed in Arm A was consistent with the known profiles of Opdivo and Yervoy, with no new safety signals identified.

Currently, Opdivo is approved as a monotherapy and in combination with Yervoy for various cancer indications, including several NSCLC settings, in the United States and the EU. In 2023, Opdivo generated $9 billion in sales, reflecting a 10% year-over-year increase and highlighting its importance to Bristol Myers Squibb's revenue.

The company is currently undertaking a comprehensive evaluation of the data from the CheckMate-73L study and intends to present the findings at a future medical conference. Despite this setback, Bristol Myers continues to evaluate Opdivo in numerous ongoing clinical trials across different phases and tumor types.

Meanwhile, Merck's Keytruda (pembrolizumab), another anti-PD-1 therapy, remains a standard of care in the frontline treatment of metastatic NSCLC. Keytruda, approved for multiple cancer types, accounted for 47% of Merck’s pharmaceutical sales in 2023.