Bristol Myers Squibb (BMS ) has reported that Opdivo (nivolumab) plus Yervoy (ipilimumab) failed to meet the primary goals of Phase III CheckMate -651 trial in platinum-eligible recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) patients.
A programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo can modulate the immune system to aid in restoring anti-tumour immune response.
Yervoy is a recombinant, human monoclonal antibody approved in about 50 countries for treating unresectable or metastatic melanoma.
The randomised, multi-centre Phase III trial compared Opdivo 3mg/kg given every two weeks along with Yervoy 1mg/kg every six weeks against cetuximab, cisplatin/carboplatin and fluorouracil called EXTREME regimen, as a first-line treatment.
Overall survival (OS) in the intent-to-treat population and OS in subjects having PD-L1-expressing tumours with a combined positive score (CPS) greater than or equal to 20 were the trial’s dual primary goals.
OS in subjects with tumours that express PD-L1 at various cut-off values, objective response rate, duration of response and progression-free survival in all patients and those with PD-L1-expressing tumours were some of the secondary goals.
Data from the trial showed that Opdivo plus Yervoy offered a positive trend towards overall survival (OS) in subjects with tumours expressing PD-L1 with a CPS ≥ 20.
The safety profile of the combination treatment was in line with earlier reported solid tumour trials.
Bristol Myers Squibb vice-president and thoracic cancers development lead Abderrahim Oukessou said: “In the CheckMate -651 trial, Opdivo plus Yervoy showed a positive overall survival trend relative to EXTREME in patients with squamous cell carcinoma of the head and neck whose tumours express PD-L1, despite the control arm performing better than expected based on historical data.
“We are disappointed that these results did not reach statistical significance, and we remain committed to advancing research and supporting patients with this difficult-to-treat cancer.”
Opdivo monotherapy provided survival benefits in recurrent or metastatic SCCHN patients following platinum-based treatment in the previous CheckMate -141 trial.
In March 2021, BMS reported primary results from the Phase II/III RELATIVITY-047 trial of a fixed-dose combination of relatlimab and Opdivo in patients with previously untreated metastatic or unresectable melanoma.