25 November 2020 - - The European Commission has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy, US-based pharmaceutical company Bristol Myers Squibb (NYSE: BMY) said.

The EC's decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival in patients who received Opdivo versus chemotherapy.

The safety profile for Opdivo was favourable compared with chemotherapy and consistent with previously reported studies of Opdivo in other solid tumors.

In addition to this approval in the EU, Opdivo has been approved in five countries, including the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC.

Bristol Myers Squibb thanks the patients and investigators involved in the ATTRACTION-3 clinical trial for their important contributions.

ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine- and platinum-based drugs.

Patient enrollment occurred predominantly in Asia, with the remainder in the United States and Europe. Patients were treated until disease progression or unacceptable toxicity.

The primary endpoint of the trial was overall survival. Secondary endpoints included investigator-assessed objective response rate, progression-free survival, disease control rate, duration of response and safety.