Bristol Myers Squibb (NYSE: BMY) has provided an update on its Phase 3 CheckMate -73L trial, revealing that it 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). The trial, CheckMate -73L, investigated the efficacy of Opdivo® (nivolumab) in combination with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab.
Joseph Fiore, vice president, global program lead, thoracic cancers at Bristol Myers Squibb, expressed disappointment, stating, “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting.” He also emphasized the ongoing need to enhance long-term outcomes for these patients and the significance of these findings for future drug development efforts.
The company plans to conduct a comprehensive evaluation of the data and collaborate with investigators to disseminate the results within the scientific community.
Despite this setback, Opdivo and Opdivo-based combinations remain approved treatment options for eligible patients with resectable or metastatic NSCLC.
CheckMate -73L is a Phase 3 randomized, open-label trial assessing Opdivo in combination with CCRT, followed by Opdivo plus Yervoy or Opdivo monotherapy, compared to CCRT alone followed by durvalumab in previously untreated patients with locally advanced stage III NSCLC. The trial involved 925 patients and evaluated various endpoints including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety.
Lung cancer, particularly non-small cell lung cancer (NSCLC), remains a leading cause of cancer-related mortality globally. While surgical resection can cure many patients, recurrence rates remain high, necessitating effective treatment options before or after surgery to improve outcomes.
Bristol Myers Squibb continues to strive towards transforming cancer care through its commitment to scientific innovation and patient-centric approaches. Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, represents a significant advancement in cancer treatment, with approvals across multiple cancers and ongoing research in various tumor types.
Opdivo’s development program, spanning multiple phases and tumor types, has contributed to a deeper understanding of biomarkers and patient care in immuno-oncology. Since its initial approval in 2014, Opdivo has become a cornerstone in cancer therapy, with regulatory approvals in numerous countries worldwide.
Bristol Myers Squibb remains dedicated to addressing the comprehensive needs of cancer patients, from diagnosis to survivorship, and continues to pioneer advancements in cancer treatment to offer patients a better future.