The European Medicines Agency (EMA) has validated new marketing authorisation applications (MAA) for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy.
Bristol Myers Squibb’s (BMS) drug will form part of a potentially new first-line treatment for adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma.
The applications are based on results from the pivotal Phase III CheckMate -648 trial, in which both Opdivo-based treatment combinations demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy.
In a statement, BMS said Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting.
“Outcomes for patients with advanced esophageal squamous cell carcinoma treated with chemotherapy alone remain poor, and there is a clear need for additional options beyond this long-standing standard of care,” said Ian M Waxman, development lead, gastrointestinal cancers, BMS.
“The validation of our applications moves us a step closer to potentially bringing these two Opdivo-based regimens to patients in the EU who may benefit.”
The validation of these applications means the EMA’s centralised review process will begin.
