Setback for Bristol Myers Squibb: CheckMate -73L trial fails to meet endpoint

Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 CheckMate -73L trial did not achieve its primary endpoint of progression-free survival (PFS) in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). This clinical trial evaluated the efficacy of Opdivo (nivolumab) combined with concurrent chemoradiotherapy (CCRT), followed by Opdivo plus Yervoy (ipilimumab) compared to CCRT followed by durvalumab.

Key Trial Insights:

– The trial’s primary goal was to assess the effectiveness of Opdivo in combination therapies against NSCLC, but it failed to show an improvement in progression-free survival, which measures the length of time during and after treatment in which the cancer does not worsen.

– The treatment regimen’s adverse events were generally consistent with the known profiles of each component, indicating no new safety concerns.

Joseph Fiore, Vice President of Global Program Lead for Thoracic Cancers at Bristol Myers Squibb, commented on the results, stating, “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting.” He emphasized the ongoing need to improve long-term outcomes for these patients and noted that the findings would guide future drug development efforts.

Study Design and Implications:

CheckMate -73L is a randomized, open-label trial that enrolled 925 patients. Participants were treated with either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C). The primary endpoint compared the progression-free survival of Arm A against Arm C, with secondary endpoints including overall survival and other efficacy measures.

Despite not meeting the primary endpoint, Bristol Myers Squibb’s commitment to advancing cancer treatment remains steadfast. The company plans a full evaluation of the trial data and aims to share the findings with the scientific community to foster further research.

Opdivo and Yervoy: Impact on Cancer Treatment:

Opdivo, a PD-1 immune checkpoint inhibitor, and Yervoy, a CTLA-4 inhibitor, are crucial components of Bristol Myers Squibb’s cancer treatment arsenal. Opdivo works by enhancing the body’s immune response against cancer cells, while Yervoy increases T-cell activation and proliferation, boosting the anti-tumor immune response. Both drugs are approved in numerous countries and have become significant options for treating various cancer types.

The outcome of the CheckMate -73L trial, though disappointing, provides valuable insights that could reshape future strategies in lung cancer therapy. Understanding the complex dynamics of cancer progression and treatment response is essential for developing more effective therapies. The trial’s comprehensive data will likely be instrumental in guiding ongoing research and development efforts in the field.