Advanced HCC: Cabozantinib Plus Atezolizumab First-Line Combination
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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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