Advanced HCC: Cabozantinib Plus Atezolizumab First-Line Combination

COSMIC-312 Phase III Trial Results

• December 15, 2021

On November 20, 2021, researchers from Comprehensive Cancer Center led by R.K. Kelley published COSMIC-312 Phase III trial results in Annals of Oncology, evaluating cabozantinib plus atezolizumab versus sorafenib in advanced hepatocellular carcinoma.

Trial Design

Patient Population: Advanced HCC (n=837; 30% HBV+, 31% HCV+, 29% Asian)

Treatment Arms (2:1:1 randomization):

• Cabozantinib 40 mg daily + Atezolizumab 1200 mg every 3 weeks (n=432)
• Sorafenib 400 mg twice daily (n=217)
• Cabozantinib 60 mg daily (n=188)

Primary Endpoints: Progression-free survival, overall survival

Key Efficacy Results

Progression-Free Survival Median:

• Cabozantinib + atezolizumab: 6.8 months
• Sorafenib: 4.2 months
• 37% mortality risk reduction

Overall Survival: No significant difference

Safety Profile

Grade 3-4 adverse events: 54% (cabozantinib + atezolizumab) vs 32% (sorafenib)

Common Grade 3-4 toxicities:

• Hand-foot skin reaction: 7.9% vs 8.2%
• Hypertension: 7.0% vs 6.3%
• AST elevation: 6.5% vs 2.4%
• Grade 5 toxicities: 1.9% vs 0.5%

Clinical Conclusions

Cabozantinib plus atezolizumab improves progression-free survival versus sorafenib monotherapy with tolerability consistent with established safety profiles.

Data Source

https://www.annalsofoncology.org/article/S0923-7534(21)04544-0/fulltext

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