(Liver Cancer) Comparing Opdivo vs. Nexavar Efficacy
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From September 27 to October 1, 2019, Thomas Yau presented at the European Society for Medical Oncology (ESMO) conference in Barcelona, Spain, the "Efficacy Comparison Results of Anti-PD-1 Antibody Opdivo (nivolumab) Monotherapy and Nexavar (sorafenib) Monotherapy as First-Line Treatment in Treatment-Naive Hepatocellular Carcinoma Patients in the CheckMate 459 Phase III Clinical Trial."
CheckMate 459 was a multicenter, randomized, controlled Phase III clinical trial. Treatment-naive hepatocellular carcinoma patients (N=743) were randomly assigned in a 1:1 ratio to either the Opdivo monotherapy group (every 2 weeks: Opdivo 240mg, N=371) or the Nexavar monotherapy group (twice daily: Nexavar 400mg, N=372). The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival and objective response rate.
At a median follow-up of 22.8 months, the results were as follows: the median overall survival (primary endpoint) was 16.4 months for the Opdivo group versus 14.7 months for the Nexavar group. Although there was a trend toward reduced mortality risk in the Opdivo group, no significant improvement was demonstrated. The 12-month overall survival rates were 59.7% for Opdivo vs. 55.1% for Nexavar, and the 24-month overall survival rates were 36.8% for Opdivo vs. 33.1% for Nexavar.
The median progression-free survival (secondary endpoint) was 3.7 months for Opdivo vs. 3.8 months for Nexavar. The objective response rate (another secondary endpoint) was 14% for Opdivo (N=57) vs. 7% for Nexavar (N=26). Complete response rates were 4% (N=14) for Opdivo vs. 1% (N=5) for Nexavar, and partial response rates were 12% (N=43) for Opdivo vs. 6% (N=21) for Nexavar.
The trial also evaluated objective response rates stratified by PD-L1 expression. For patients with PD-L1 expression below 1%, objective response rates were 12% for Opdivo (N=36) vs. 7% for Nexavar (N=20). For patients with PD-L1 expression of 1% or more, objective response rates were 28% for Opdivo (N=20) vs. 9% for Nexavar (N=6), demonstrating that patients with higher PD-L1 expression had better objective response rates with Opdivo.
Regarding safety, no new adverse events were observed in the Opdivo group compared to previous trials. Grade 3 and 4 adverse event rates were 22% (N=81) for Opdivo vs. 49% (N=179) for Nexavar. Treatment discontinuation rates due to adverse events were 4% (N=16) for Opdivo vs. 8% (N=29) for Nexavar.
Based on the CheckMate 459 clinical trial results, Thomas Yau stated: "In this trial, there was no significant difference in the primary endpoint of overall survival between the two groups. However, current first-line standard treatment for hepatocellular carcinoma with Nexavar does not meet all patients' medical needs. This trial shows that Opdivo monotherapy not only improved overall survival but also reflected a high complete response rate, and may become one of the optimal treatment options for hepatocellular carcinoma patients."
Source: Nivolumab Challenges Sorafenib as First-line Treatment in Advanced HCC [ESMO 2019 Oncology news]
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