Regulatory Decision Summary for Opdivo

Authorization was based on an international, multi-centre, randomized, open label, phase III trial. Patients with untreated, unresectable MPM were randomized (1:1) to receive either 3 mg/kg Opdivo every 2 weeks plus 1 mg/kg ipilimumab every 6 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity (n = 303), or platinum-doublet chemotherapy every 3 weeks for 6 cycles (n = 302). The study met its primary efficacy endpoint of overall survival. The median overall survival was 18.1 months with Opdivo plus ipilimumab and 14.1 months with platinum-doublet chemotherapy.

The most common adverse reactions (ADRs) reported in at least 10% of patients who received Opdivo plus ipilimumab were rash, pruritus, fatigue, diarrhea, nausea and hypothyroidism. The safety findings were consistent with the safety profiles of Opdivo and ipilimumab that were established in previous studies.

The recommended dose of Opdivo is either 3 mg/kg every 2 weeks or 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. View the Opdivo Product Monograph for details.

Overall, the benefit/risk profile of Opdivo in combination with ipilimumab is considered favourable in patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.