(Mesothelioma) Is Opdivo Effective in Patients with Disease Progression After Platinum-Based Chemotherapy?
(Mesothelioma) Is Opdivo Effective in Patients with Disease Progression After Platinum-Based Chemotherapy?
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(Mesothelioma) Is Opdivo Effective in Patients with Disease Progression After Platinum-Based Chemotherapy?
- October 22, 2021
- 2 min read
On October 1, 2021, Dean A Fennell et al. from Leicester Cancer Research Centre published in The Lancet the efficacy and safety results from a Phase 3 clinical trial (NCT03063450) evaluating the anti-PD-1 antibody Opdivo in patients with pleural mesothelioma or malignant peritoneal mesothelioma who had experienced disease progression following platinum-based chemotherapy.
This Phase 3 clinical trial was conducted across multiple centers. Patients with pleural mesothelioma or malignant peritoneal mesothelioma who had experienced disease progression following platinum-based chemotherapy (N=332) were randomized 2:1 into an Opdivo group (240 mg every two weeks, for up to 12 months, N=221) and a placebo group (N=111). The primary endpoints were progression-free survival and overall survival.
The rationale for this trial was that previous Phase 3 clinical trials using other agents in patients with pleural mesothelioma or malignant peritoneal mesothelioma who had progressed on platinum-based therapy showed no significant improvement in overall survival. Therefore, this trial investigated the efficacy of the anti-PD-1 antibody Opdivo.
At a median follow-up of 11.6 months, the median progression-free survival for the primary endpoint was 3.0 months in the Opdivo group vs. 1.8 months in the placebo group, representing a 33% reduction in the risk of disease progression or death in the Opdivo group.
For the other primary endpoint, the median overall survival was 10.2 months in the Opdivo group vs. 6.9 months in the placebo group, representing a 31% reduction in the risk of disease progression or death in the Opdivo group.
Regarding safety, grade 3 or higher adverse events confirmed in the majority of patients included diarrhea (Opdivo group 3% vs. placebo group 2%) and infusion reactions (Opdivo group 3% vs. placebo group 0%). Serious adverse events were reported in 41% (N=90/221) of the Opdivo group vs. 44% (N=49/111) of the placebo group. One death due to adverse events was confirmed.
Based on the results of the Phase 3 clinical trial, Dean A Fennell et al. concluded that the treatment of patients with pleural mesothelioma or malignant peritoneal mesothelioma who had progressed following platinum-based chemotherapy with the anti-PD-1 antibody Opdivo demonstrates therapeutic potential with clinical benefit.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00471-X/fulltext
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