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Nivolumab Shows Potential Benefit for Patients with Malignant Mesothelioma
According to results from a phase 3 trial, nivolumab may be beneficial for patients with malignant mesothelioma, who progressed following platinum-based chemotherapy (Lancet Oncol. 2021 Oct 14:S1470-2045(21)00471-X.).
“No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab, an anti-PD-1 antibody, in these patients,” explained Dean Fennel, FRCP, PhD, Mesothelioma Research Program, Leicester Cancer Research Centre, University of Leicester, UK, and colleagues.
The multicentre, placebo-controlled, double-blind, randomized trial took place across 24 hospitals in the UK. Adult patients with histologically confirmed pleural or peritoneal mesothelioma who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression were included. An Eastern Cooperative Oncology Group performance status of 0 to 1 was also required.
Patients were assigned randomly (2:1) to receive either nivolumab 240mg every two weeks over 30 minutes intravenously or placebo until disease progression or 12 months. The primary end points included investigator-assessed progression-free survival (PFS) and overall survival (OS), analyzed according to the treatment policy estimand. All patients were included in the safety population.
Of the 332 patients recruited, 221 (67%) were assigned to nivolumab and 111 (33%) to placebo. The median follow-up was 11.6 months (IQR 7.2–16.8), and the median PFS in the nivolumab and placebo groups was 3.0 months (95% CI, 2.8-4.1) and 1.8 months (95% CI, 1.4-2.6), respectively (HR 0.67; 95% CI, 0.53-0.85; P=00012). Additionally, the median OS was 10.2 months (95% CI, 8.5-12.1) in the nivolumab group, compared to 6.9 months (95% CI, 5.0-8.0) in the placebo group (HR 0.69; 95% CI 0.52-91; P=0.0090)
The most common treatment-related adverse events (AEs) of grade 3 or higher were diarrhea (3% in the nivolumab group, 2% in placebo) and infusion-related reaction (3%, 0%). There were no treatment-related deaths in either group.
“Nivolumab represents a treatment that might be beneficial to patients with malignant mesothelioma who have progressed on first-line therapy,” concluded D Fennel et al.—Alexandra Graziano
