Bristol Myers Squibb has announced positive results from the Phase 3 CheckMate -648 trial, which showed nivolumab plus chemotherapy and nivolumab plus ipilimumab demonstrated a superior survival benefit compared to chemotherapy in unresectable advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
Nivolumab plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumours express PD-L1 and in the all-randomised patient population at the pre-specified interim analysis.
Additionally, 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 tumours express PD-L1.
Nivolumab plus ipilimumab also met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in OS in patients whose tumours express PD-L1 and in the all-randomised population.
Nivolumab plus ipilimumab did not meet its other primary endpoint of PFS by BICR in patients whose tumours express PD-L1.
The results for these nivolumab-based combinations represent a significant advancement for patients with oesophageal cancer who are often diagnosed after their disease has spread and would benefit from new therapeutic options.
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 tumour locations (stomach, gastroesophageal junction and oesophagus).
They also add to the existing body of data demonstrating the clinical benefit of nivolumab in oesophageal cancer, from the late-line metastatic setting to earlier stages of disease.
More information about the CheckMate -648 trial is here.
Source: Bristol Myers Squibb