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The Food and Drug Administration (FDA) has approved Imjudo (tremelimumab-actl) in combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (HCC).
Imjudo is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The novel dose and schedule of the combination (the STRIDE regimen [Single Tremelimumab Regular Interval Durvalumab]) includes a single priming dose of tremelimumab via intravenous infusion added to durvalumab (Imfinzi), a programmed death-ligand 1 (PD-L1) blocking antibody, followed by durvalumab every 4 weeks.
The approval was based on data from the open-label, phase 3 HIMALAYA trial (ClinicalTrials.gov Identifier: NCT03298451), which evaluated the efficacy and safety of tremelimumab plus durvalumab as first-line treatment in adults with unresectable HCC. Patients received a single priming dose of tremelimumab 300mg added to durvalumab 1500mg (n=393) followed by durvalumab every 4 weeks vs sorafenib (n=389). The primary endpoint was overall survival.
Results showed that patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death vs sorafenib (hazard ratio [HR], 0.78, 95% CI 0.66-0.92; P =.0035). Median overall survival was reported to be 16.4 months (95% CI, 14.2-19.6) for the STRIDE group compared with 13.8 months (95% CI, 12.3-16.1) for the sorafenib group.
Objective response rate and median duration of response, respectively, were 20.1% and 22.3 months for STRIDE and 5.1% and 18.4 months for sorafenib. Durvalumab monotherapy also demonstrated noninferior overall survival to sorafenib (HR, 0.86; 95.67% CI 0.73-1.03).
Nearly 31% of STRIDE-treated patients were still alive at 3 years vs 20% of those who received sorafenib. No new safety signals were identified during the trial.
The most common adverse reactions reported were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, abdominal pain, increased AST/ALT, decreased hemoglobin, decreased sodium, increased bilirubin, increased alkaline phosphatase, and decreased lymphocytes.
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA phase 3 trial, said: “Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease.”
Imjudo is supplied as 25mg/1.25mL and 300mg/15mL solution in single-dose vials. The product is expected to be available in early November 2022.
References
- Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. News release. AstraZeneca. Accessed October 24, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-and-imjudo-approved-in-advanced-liver-cancer.html
- Imjudo. Package insert. AstraZeneca; 2022. Accessed October 24, 2022. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0102c6fd-de8a-4b43-afa3-2a2c2115d472/0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf
