Ono Pharmaceutical Korea and BMS Pharmaceutical Korea said on Monday that Opdivo (ingredient: nivolumab), an anti-PD-1 monoclonal antibody, was approved as a combination of two treatments for progressive or metastatic esophageal squamous cell cancer (ESCC) by the Ministry of Food and Drug Safety.

Both Opdivo and Yervoy are already used as a combination treatment for many types of advanced cancer including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and hepatocellular carcinoma.

The expanded indication includes Opdivo-Yervoy (ingredient: ipilimab) combo as a first-line treatment and Opdivo-fluoropyrimidine and platinum-based chemotherapy combo as a first-line therapy.

The expanded indication was granted based on the multicenter, global, randomized, and open-label phase 3 clinical trial of CheckMate-648.

The study compared and evaluated the combination of Opdivo-Yervoy and Opdivo-chemotherapy alone in patients with progressive, recurrent, or metastatic ESCC.

The primary outcome of the study evaluated the overall survival (OS) of two combination therapies using Opdivo and chemotherapy in a patient group with a PD-L1 expression rate of 1 percent or more, and progression-free survival (PFS) evaluated by the blinded independent central review committee (BRIC).

The secondary endpoints were OS and PFS in the total randomized patient population.

According to the pre-specified interim analysis result of the clinical trial, the combined treatment using Opdivo showed statistically and clinically significant overall survival (OS) improvements in patients with a PD-L1 expression rate of 1 percent or higher compared to chemotherapy alone in all randomly assigned patients.

Additionally, the safety profile of the combination of the Opdivo-Yervoy and Opdivo-chemotherapy was consistent with the previously reported results for Opdivo therapies.