IMFINZI (durvalumab) and IMJUDO (tremelimumab) - Hepatocellular carcinoma (HCC)

The Committee deems that the clinical benefit of the IMFINZI (durvalumab) and IMJUDO (tremelimumab) combination is substantial in the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), only in patients with preserved hepatic function (Child-Pugh A), an ECOG score of 0 or 1, and not eligible for locoregional therapies or in the event of failure of one of these therapies.

Considering:

• demonstration of a superiority of the IMFINZI (durvalumab) and IMJUDO (tremelimumab) combination compared to sorafenib in terms of overall survival (HR = 0.78; CI95% [0.66; 0.92]; p = 0.0035), with a point estimate of an absolute gain of 2.66 months in a randomised, open-label phase 3 study,

and despite:

• a toxicity profile marked primarily by an excess of serious adverse events (40.5% in the D+T 300 mg group and 29.7% in the S group), in particular immune-mediated SAEs,
• uncertainties with respect to the transposability of the results of the pivotal study to French patients (patients predominantly native to Asia, in whom the distribution of hepatocarcinoma aetiologies does not correspond to French epidemiological conditions),
• the lack of demonstrated impact on quality of life,
• the impossibility of defining the precise role of this treatment combination compared to the atezolizumab - bevacizumab combination, both developed concomitantly,

the Committee considers that the IMFINZI (durvalumab) and IMJUDO (tremelimumab) combination provides a minor clinical added value (CAV IV) compared to sorafenib in the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (CHC), only in patients with preserved hepatic function (Child-Pugh A), an ECOG score of 0 or 1, and not eligible for locoregional therapies or in the event of failure of one of these therapies.