CheckMate 648: Safety profile in the ITT population¹

No new safety signals were identified with longer follow-up.

The table below shows a summary of treatment-related adverse events in the ITT population. Please note that the EMA indication is limited to patients with tumour cell PD-L1 expression ≥ 1 %.

The incidence of treatment-related adverse events of grade 3 or 4 was higher among patients who received OPDIVO + chemotherapy than among those who received OPDIVO + YERVOY or chemotherapy alone. Treatment-related serious adverse events of any grade were more common with OPDIVO plus chemotherapy and OPDIVO + YERVOY than with chemotherapy alone. The percentage of patients who had a treatment-related adverse event of any grade that led to discontinuation of any drug in the regimen was higher with OPDIVO + chemotherapy than with OPDIVO + YERVOY or chemotherapy alone.

Minimum follow-up: 28.8 months