NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for two biomarker-defined Opdivo (nivolumab) indications, sponsor Bristol Myers Squibb said on Friday.
CHMP recommended approval for Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for patients with unresectable advanced, recurrent, or metastatic esophageal cancer with PD-L1 expression greater than or equal to 1 percent. The committee also recommended approval for Opdivo monotherapy as an adjuvant treatment for muscle-invasive urothelial cancer with tumor cell PD-L1 expression greater than or equal to 1 percent.
The European Commission will now weigh CHMP's recommendations for both indications as it considers whether to approve Opdivo in these settings for patients in Europe.
The recommendation in esophageal cancer is based on data from the Phase III CheckMate-648 trial, which showed Opdivo plus chemotherapy improved survival compared to chemotherapy alone in the overall population and the PD-L1-positive subgroup. Patients treated with the Opdivo combination had a median overall survival of 15.4 months, compared to 9.1 months in the chemotherapy arm. The study also showed patients with PD-L1 expression greater than 1 percent responded better to Opdivo and chemo compared to those with lower or no PD-L1 expression.
The recommendation for urothelial cancer was based on results from the Phase III CheckMate-274 study, comparing adjuvant treatment with single-agent Opdivo against placebo. In the overall study population, the median disease-free survival in the Opdivo arm was 21 months compared to 10.9 months with placebo. In patients with PD-L1 expression greater than 1 percent, the median disease-free survival was not reached with Opdivo versus 10.8 months for placebo, which translated to a 47 percent reduction in the risk of disease recurrence or death.
Opdivo was approved in the US in August 2021 as an adjuvant treatment for urothelial cancer patients at high risk of recurrence after surgery, regardless of patients' PD-L1 expression levels. In September, BMS submitted data from CheckMate-648 to the FDA seeking approval for Opdivo-based regimens in patients with unresectable advanced or metastatic esophageal cancer.