Regimen extends PFS, not OS, in advanced liver cancer
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The combination of cabozantinib and atezolizumab prolonged PFS compared with sorafenib among patients with previously untreated advanced hepatocellular carcinoma, according to topline data released by one of the agent’s manufacturers.
However, the experimental regimen did not confer a significant OS benefit, results of the randomized phase 3 COSMIC-312 trial showed.
“[Although] we are encouraged by the data supporting the potential for the combination of cabozantinib and atezolizumab to reduce the risk [for] disease progression or death, we are disappointed by the interim result of lack of significant improvement on overall survival versus the comparator arm,” Michael M. Morrissey, PhD, president and CEO of Exelixis, said in a company-issued press release. “As these data continue to mature, we are working to understand the potential impact of various contributing factors on the results, including patient demographics, subsequent anti-cancer therapy and the impact of COVID-19 on the trial.”
The global, multicenter COSMIC-312 trial aimed to enroll up to 840 patients with untreated advanced HCC.
Researchers randomly assigned patients 2:1:1 to one of three arms: 40 mg cabozantinib (Cabometyx, Exelixis), a multitargeted tyrosine kinase inhibitor, plus the anti-PD-1 agent atezolizumab (Tecentriq, Genentech); sorafenib (Nexavar, Bayer) alone; or cabozantinib alone at a 60-mg dose.
PFS and OS served as primary endpoints.
Results of the planned primary analysis showed a statistically significant PFS benefit with the cabozantinib-atezolizumab combination compared with sorafenib (HR = 0.63; 99% CI, 0.44-0.91).
A prespecified interim analysis for OS showed no significant benefit with the cabozantinib-atezolizumab regimen.
The combination exhibited a safety profile consistent with the known profiles of the individual medicines.
Exelixis officials intend to present the results at a medical conference and may proceed with a regulatory filing with the FDA, according to the release.
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