Nivolumab Combinations Demonstrate Superior Survival Benefit in Esophageal Squamous Cell Carcinoma

Topline results from the phase 3 CheckMate-648 trial evaluating treatment with nivolumab (Opdivo, Bristol Myers Squibb) plus chemotherapy or nivolumab plus ipilimumab (Yervoy, Bristol Myers Squibb) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) were announced recently.

This study showed nivolumab plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express programmed death-ligand 1 (PD-L1) and in the all-randomized patient population at the pre-specified interim analysis.

Further, nivolumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1, according to the study.

In addition, nivolumab plus ipilimumab met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 and the all-randomized population. However, this combination did not meet its other primary endpoint of PFS by BICR in patients whose tumors express PD-L1.

“The results for these Opdivo-based combinations represent a significant advancement for patients with esophageal cancer who are often diagnosed after their disease has spread and would benefit from new therapeutic options,” said Ian M. Waxman, MD, development lead, gastrointestinal cancers, Bristol Myers Squibb, in a press release. “This study further demonstrates our commitment to pursue combination strategies that improve outcomes for patients with high unmet need, such as those with gastrointestinal cancers.”

The data from CheckMate-648 build upon those from CheckMate-649, together making nivolumab the first and only PD-1/L1 inhibitor to demonstrate superior first-line survival in upper GI cancers across histologies and tumor locations. Also, the data add to the existing body of data surrounding the clinical benefit of nivolumab in esophageal cancer, from the late-line metastatic setting to earlier stages of disease, according to the study.

REFERENCE

Bristol Myers Squibb Announces Opdivo (nivolumab) plus Chemotherapy and Opdivo plus Yervoy (ipilimumab) Demonstrate Superior Survival Benefit Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma. Published April 8, 2021. Accessed April 8, 2021. https://news.bms.com/news/details/2021/Bristol-Myers-Squibb-Announces-Opdivo-nivolumab-plus-Chemotherapy-and-Opdivo-plus-Yervoy-ipilimumab-Demonstrate-Superior-Survival-Benefit-Compared-to-Chemotherapy-in-Unresectable-Advanced-or-Metastatic-Esophageal-Squamous-Cell-Carcinoma/default.aspx