Opdivo Combo Misses PFS Goal in Unresectable Lung Cancer

Bristol Myers Squibb has revealed that their Phase III clinical trial, CheckMate-73L, failed to achieve its primary endpoint of progression-free survival (PFS) for a specific treatment combination aimed at patients with advanced non-small-cell lung cancer (NSCLC). This study explored the efficacy of using Opdivo (nivolumab) along with concurrent chemoradiotherapy (CCRT), followed by a combination of Opdivo and Yervoy (ipilimumab), as opposed to the currently established treatment of CCRT followed by AstraZeneca’s Imfinzi (durvalumab).

The trial, which involved 925 newly diagnosed patients suffering from stage III NSCLC who were not candidates for curative surgery, randomized participants into three distinct treatment groups. The first group received Opdivo plus CCRT followed by Opdivo and Yervoy; the second group was treated with Opdivo plus CCRT followed by Opdivo alone; and the third group received the conventional treatment of CCRT followed by Imfinzi. The primary goal was to compare the PFS between the first and third groups, while overall survival rates across all treatment groups constituted a significant secondary objective.

Despite the high expectations, the primary aim was not met. Bristol Myers Squibb refrained from disclosing the specific data points, indicating that a comprehensive analysis would be available once the evaluation process is fully completed. Joseph Fiore, the global program lead for thoracic cancers at the company, emphasized the ongoing necessity for improved long-term treatment outcomes for NSCLC patients. He suggested that the study results, although not successful in meeting their primary endpoint, could still contribute valuable insights for future therapeutic development.

The CheckMate-73L trial is not the only study to confront difficulties in this challenging area of cancer treatment. Last year, AstraZeneca’s Phase III PACIFIC-2 trial, which examined Imfinzi plus CCRT in a similar patient population, also did not meet its primary endpoint. This highlights the complexity and difficulty of achieving significant improvements in treatment for patients with this form of lung cancer.

Opdivo, both as a standalone therapy and in combination with other treatments, has previously received approvals for treating various forms of NSCLC, including resectable or metastatic cases. However, this latest setback underscores the ongoing challenges in enhancing therapeutic strategies for patients with unresectable stage III NSCLC.

In conclusion, while the Bristol Myers Squibb's CheckMate-73L study did not achieve its main objective, the data and experiences gathered are expected to guide and shape future research in this field. The continued focus on improving patient outcomes remains a critical priority for researchers and pharmaceutical companies alike.