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New Indication: Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma (HIMALAYA)

New Indication: Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma (HIMALAYA)
Study:
  • Open-label, phase 3 trial
  • Unresectable hepatocellular carcinoma and no previous systemic treatment
  • Tremelimumab (300 mg, one dose) plus durvalumab (1500 mg every 4 weeks; STRIDE, n=393), durvalumab (1500 mg every 4 weeks, n=389), or sorafenib (400 mg twice daily, n=389)
Efficacy:
  • mOS: 16.43 vs.13.77 mos, HR:0.77, p=0.0035 ( STRİDE vs.Sorafenib)
  • 36-mos OS: 30.7% vs. 20.2% (STRİDE vs.Sorafenib)
  • mOS: 16.56 vs. 13.77 mos, HR:0.86, p=0.067) (Durvalumab vs. Sorafenib)
  • ORR: 20.1% vs. 17.0% vs. 5.1%
Safety:
  • Any grade AEs: diarrhea (26.5%; 14.9%; 44.7%), pruritus (22.9%; 14.4%; 6.4%), rash (22.4%; 10.3%; 13.6%), hypertension (5.9%; 4.4%; 18.2%), fatigue (17.0%; 8.9%; 19.0%), palmar-plantar syndrome (0.8%; 0.3%; 46.5%).
  • Grade ≥3 AEs: palmar-plantar syndrome (0; 0; 9%), hypertension (1.8%; 1.0%, 6.1%)

NEJM Evid 2022; 1 (8)

Ghassan K. Abou-Alfa et al. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma

https://doi.org/ 10.1056/EVIDoa2100070

Reviewed by Elvin CHALABİYEV, MD on Jan 30, 2023

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