medwireNews: Treatment with single-agent nivolumab improves the outcomes of previously treated patients with malignant mesothelioma, suggest phase 3 study results.
The co-primary endpoints of progression-free survival (PFS) and overall survival (OS) were significantly prolonged for patients who received nivolumab than those given placebo, reported study author Dean Fennell, from the University of Leicester in the UK, at the IASLC 2020 World Conference on Lung Cancer.
He therefore believes that the PD-1 inhibitor “should be considered a new treatment option” for this patient population.
The Stand Up To Cancer/Cancer Research UK CONFIRM trial recruited 332 individuals who had received at least one prior therapy for malignant mesothelioma (pleural or peritoneal), and randomly assigned them to receive either nivolumab 3 mg/kg every 2 weeks or placebo. The median follow-up in the nivolumab and placebo groups was 17.1 and 14.2 months, respectively.
PFS was a median of 3.0 months for the 221 participants given nivolumab and 1.8 months for their 111 counterparts who received placebo, a significant difference equating to a hazard ratio (HR) for progression or death of 0.61. The 12-month PFS rates were 14.5% and 4.9%, respectively.
Median OS was also significantly longer in the nivolumab than placebo group, at 9.2 versus 6.6 months, giving an HR for death of 0.72, and the 12-month OS rate was higher, at 39.5% compared with 26.9% for the placebo arm.
Analysis by histology showed that patients with epithelioid disease appeared to derive a significant OS benefit from nivolumab versus placebo (HR=0.71), whereas although the HR of 0.79 in the non-epithelioid group favored nivolumab, it was not statistically significant.
The presenter pointed out, however, that the OS data were immature at the time of analysis.
“The safety profile of nivolumab was consistent with its known profile with no new safety signals,” he continued. Grade 3 or worse adverse events (AEs) occurred in 45.0% of participants in the nivolumab group and 42.0% of those in the placebo group. The corresponding rates of serious AEs were 36.0% and 39.0%, with related deaths in 3.6% and 5.3%.
Putting these findings in the context of the CheckMate 743 trial showing a survival benefit of nivolumab–ipilimumab in the first-line, Fennell told medwireNews that he certainly expects a push towards using immunotherapy in the treatment-naïve setting, as has happened in other tumor types.
But he noted that for the many patients who have already received first-line chemotherapy, “getting access to [a] second-line therapy with evidence of efficacy is key,” and based on the CONFIRM data, nivolumab could be “an appropriate relapse or salvage strategy.”
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IASLC 2020 World Conference on Lung Cancer; 28–31 January 2021