CHMP recommends approval of Opdivo in recurrent or metastatic oesophageal squamous cell carcinoma.- BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. The European Commission, which is authorized to approve medicines for the European Union, will now review the CHMP recommendation. The CHMP positive opinion was based on results from the Phase III ATTRACTION-3 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival in patients who received Opdivo versus chemotherapy, as well as a favorable safety profile. The study enrolled adults who were refractory or intolerant to at least one fluoropyrimidine- and platinum-based combination regimen, regardless of PD-L1 expression level. Patients treated in the Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels. An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy. Fewer treatment-related adverse events (TRAEs) were reported with Opdivo versus chemotherapy, with a rate of 66% for any grade TRAEs for patients receiving Opdivo compared to 95% for patients receiving chemotherapy.