Nivolumab Effective for Relapsed Malignant Mesothelioma

Malignant mesothelioma cells.

In patients with relapsed malignant mesothelioma, nivolumab improves both overall and progression-free survival with a tolerable safety profile, according to results of the phase 3 CONFIRM trial recently presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer.

“Malignant mesothelioma is an intractable cancer,” write the investigators, led by Dean Fennell, PhD, FRCP, Chair of Thoracic Medical Oncology at Leicester Cancer Research Centre in the United Kingdom, in their presentation abstract. “No therapy has yet shown an improvement in overall survival following standard first-line chemotherapy doublet comprising pemetrexed and cisplatin or carboplatin since it was licensed in 2004. Nivolumab is a programmed death ligand 1 (PD-L1) inhibitor that has shown activity in previously treated malignant mesothelioma in two single-arm phase 2 clinical trials.”

CONFIRM enrolled 332 patients with previously treated, unresectable, histologically confirmed pleural or peritoneal malignant mesothelioma with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Baseline characteristics were similar across treatment arms, with 87% of patients having an epithelioid histology and 96% receiving their third or later line of therapy. Patients were randomized in a 2:1 ratio to receive either 3 mg/kg nivolumab or placebo once every two weeks for a maximum of 12 months or until disease progression. The primary end points were overall and progression-free survival, with a secondary end point of best overall response and exploratory end points of safety and tolerability.

Overall survival data was immature at the time of data cutoff but demonstrated longer survival in the nivolumab arm, with a median overall survival of 9.2 months compared with 6.6 months for placebo (hazard ratio 0.72). Patients receiving nivolumab experienced a longer median progression-free survival compared with placebo (3.0 vs 1.8 months, hazard ratio 0.62). Both overall and progression-free survival reached statistical significance. Grade 3/4 treatment-related adverse events were experienced by 19% of patients receiving nivolumab and 6.3% of those receiving placebo, with treatment discontinuation occurring in 13.1% of patients in the nivolumab group and 2.7% of those in the placebo group.

“CONFIRM met its coprimary end points of improved overall survival and progression-free survival with nivolumab versus placebo in relapsed malignant mesothelioma,” conclude Dr. Fennell and colleagues. “The safety profile of nivolumab was consistent with its known profile with no new safety signals. Nivolumab monotherapy is an effective treatment option for relapsed malignant mesothelioma.”

For More Information

Fennell D, et al (2021). Nivolumab versus placebo in relapsed malignant mesothelioma: the CONFIRM phase 3 trial. World Conference on Lung Cancer Abstracts. Abstract PS01.11.

Image credit: Nephron. Licensed under CC BY-SA 3.0

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