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Phase III COSMIC-312 trial of Cabometyx and Tecentriq meets primary endpoint in hepatocellular carcinoma.

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Last updated:22nd Nov 2021
Published:22nd Nov 2021
Exelixis announced detailed results from the first planned analysis of COSMIC-312, the ongoing phase III pivotal trial evaluating Cabometyx (cabozantinib) in combination with Tecentriq (atezolizumab) versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC).

As initially announced in June, at a median follow-up of 15.8 months, the primary analysis showed the primary endpoint of progression-free survival (PFS) per RECIST 1.1 by blinded independent review committee (BIRC) was met; in the PFS intent-to-treat (PITT) population, cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib (hazard ratio [HR]: 0.63; 99% confidence interval [CI]: 0.44-0.91; P=0.0012; pre-specified critical p-value of 0.01). Median PFS was 6.8 months for cabozantinib in combination with atezolizumab (n=250) versus 4.2 months for sorafenib (n=122).

New results presented during the 2021 ESMO Virtual Plenary include detailed data for a prespecified interim analysis for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population, which was conducted at the same time as the primary analysis for PFS in the PITT population. At a median follow-up of 13.6 months, the interim OS analysis in the ITT population showed a trend that favored cabozantinib in combination with atezolizumab but did not reach statistical significance (HR: 0.90; 96% CI: 0.69-1.18; P=0.438). Median OS was 15.4 months for cabozantinib in combination with atezolizumab (n=432) versus 15.5 months for sorafenib (n=217).

The trial is continuing as planned to the final analysis of OS, anticipated in early 2022. The data are being presented in the Virtual Plenary Session during the European Society for Medical Oncology (ESMO) Asia Virtual Oncology Week 2021.

Condition: Liver Cancer
Type: drug

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