Imjudo

Imjudo (tremelimumab) is a new active substance recommended for marketing authorization for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). The recommended dose of Imjudo is 300 mg. The marketing authorization application was submitted on 4 March 2022, and a positive opinion from the CHMP was issued on 15 December 2022.

In the HIMALAYA study, a randomized, open-label, multicenter Phase III study, the median Overall Survival (OS) for sorafenib in advanced HCC was 10.7 months, with subsequent studies showing 10.7 to 13.4 months. For lenvatinib, median OS was 13.6 months compared to 12.3 months for sorafenib. In previously treated HCC, nivolumab plus ipilimumab showed an Objective Response Rate (ORR) of 32%. In a SARCOMA cohort, median Progression-Free Survival (PFS) was 1.7 months, and median Overall Survival (OS) was 6.6 months, with a 12-month survival rate of 25.6%. In a STO cohort, median PFS was 1.7 months, median OS was 6.9 months, with 12-month and 24-month survival rates of 40.0% and 30.0% respectively. The Objective Response Rate (ORR) in the STO cohort was 11.1%.

Regarding safety, immune-mediated adverse events (AEs) were observed. In the HCC T300+D pool, any immune-mediated AE occurred in 36.1% of patients, with 13.4% experiencing CTCAE Grade 3 or 4 immune-mediated AEs, and 10.2% experiencing serious immune-mediated AEs (SAEs). Immune-mediated AEs with an outcome of death occurred in 1.3% of patients in this pool.