The European Commission has approved expanding the use of ceritinib to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive.

Approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP), and is applicable to all 28 European Union member states plus Iceland, Lichtenstein and Norway.

The first-line approval of ceritinib is based on results from an open-label, randomised, multicenter, global, Phase III trial, ASCEND-4.

The study met its primary endpoint, demonstrating a 45% reduction in the risk of disease progression in the ceritinib arm, compared to the chemotherapy arm (hazard ratio [HR] = 0.55 [95% confidence interval (CI): 0.42, 0.73; one-sided p value <0.0001])1.

Patients treated with first-line ceritinib had a median progression-free survival (PFS) of 16.6 months (95% CI: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance1.

Overall intracranial response rate (OIRR) in patients with measurable brain metastases at baseline and at least one post-baseline assessment was 72.7% (95% CI: 49.8, 89.3; n = 22) for patients treated with ceritinib, versus 27.3% (95% CI: 10.7, 50.2; n = 22) for patients treated with chemotherapy1.

The whole body overall response rate (ORR) was 72.5% (95% CI: 65.5, 78.7; n = 189) in patients treated with ceritinib1.

Further, patients without brain metastases at screening receiving ceritinib experienced a median PFS of 26.3 months (95% CI: 15.4, 27.7), compared with 8.3 months (95% CI: 6.0, 13.7) among patients treated with chemotherapy (HR = 0.48 [95% CI: 0.33, 0.69])1.

Among patients with brain metastases at screening, the median PFS was 10.7 months (95% CI: 8.1, 16.4) in the ceritinib group, versus 6.7 months (95% CI: 4.1, 10.6) in the chemotherapy group (HR = 0.70 [95% CI: 0.44, 1.12])1.

Source: Novartis