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New Indication: Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312)

New Indication: Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312)
Study:
  • Open-label, randomised, phase 3 trial
  • Previously untreated advanced hepatocellular carcinoma
  • Cabozantinib 40 mg plus atezolizumab 1200 mg IV every 3 weeks (N:432), sorafenib 400 mg twice Daily (n:217), or cabozantinib 60 mg orally once daily (188)
Efficacy:
  • mPFS: 6·8 months (99% CI 5·6–8·3) in the combination treatment group vs 4·2 months (2·8–7·0) in the sorafenib group (hazard ratio [HR] 0·63, 99% CI 0·44–0·91, p=0·0012)
  • mOS: 15·4 months in the combination treatment group vs 15·5 months in the sorafenib group (HR 0·90, 96% CI 0·69–1·18; p=0·44).
Safety:
  • Any grade TEAE: 428 (>99%) of 429 patients vs 205 (99%) of 207 patients vs 187 (99%) of 188
  • Grade 3-4 AEs: 273 (64%), 95 (46%), and 113 (60%); ALT increase 9%, 3%, 6%; hypertension 9%, 8%,12%
  • Any grade treatment-emergent haemorrhagic events 71 (17%) vs 29 (14%) vs 28 (15%)

Lancet Oncol. 2022 Aug;23(8):995-1008.

Kelley RK, Rimassa L, Cheng AL, et al. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial.

https://doi.org/10.1016/s1470-2045(22)00326-6

Reviewed by Hasan Çağrı Yıldırım, MD on Aug 16, 2022

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