The Food and Drug Administration has approved the combination of nivolumab plus ipilimumab as first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

Efficacy was investigated in CHECKMATE-743 (NCT02899299), a randomised, open-label trial in patients with unresectable malignant pleural mesothelioma and no prior anticancer therapy.

Patients were randomised to receive either nivolumab and ipilimumab for up to 2 years (n=303) or 6 cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n=302).

The trial demonstrated a statistically significant improvement in overall survival (OS) for patients treated with nivolumab plus ipilimumab compared with those who received chemotherapy.

Median OS was 18.1 months (95% CI: 16.8, 21.5) versus 14.1 months (95% CI: 12.5, 16.2) (HR 0.74; 95% CI: 0.61, 0.89; p=0.002).

Median progression-free survival per blinded independent central review (BICR) was 6.8 months (95% CI: 5.6, 7.4) in the nivolumab plus ipilimumab arm and 7.2 months (95% CI: 6.9, 8.1) in the chemotherapy arm (HR 1.0; 95% CI 0.82, 1.21).

Confirmed overall response rate per BICR was 40% (95% CI: 34, 45) and 43% (95% CI 37, 49) in the nivolumab plus ipilimumab and chemotherapy arms, respectively.

Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm.

The most common adverse reactions (incidence ≥ 20%) in patients receiving the combination of nivolumab plus ipilimumab in CHECKMATE-743 were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.

The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

View full prescribing information for nivolumab

View full prescribing information for ipilimumab

Source: FDA