AstraZeneca’s drug combination Imfinzi plus tremelimumab has been shown to significantly improve overall survival for patients with first-line unresectable liver cancer. The positive high-level results demonstrated that tremelimumab added to Imfinzi demonstrated statistically and clinically meaningful overall survival vs sorafenib.
Patients in the trial were those with unresectable hepatocellular carcinoma (HCC) who had not received systemic therapy treatment previously, and were not eligible for localised treatment.
The company’s HIMALAYA Phase III trial compared sorafenib to tremelimumab plus Imfinzi and an Imfinzi monotherapy. Imfinzi on its own demonstrated non-inferior overall survival with a numerical trend in favour of Imfinzi as well as improved tolerability profile compared to sorafenib.
The randomised, open-label, multicentre trial, which uses the single tremelimumab regular interval durvalumab (STRIDE) regimen, has a total of 1,324 patients enrolled with unresectable, advanced HCC.
HCC is the most common type of liver cancer, which is the third leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Around 900,000 people are diagnosed with liver cancer each year, and only 7% of patients with advanced disease survive five years.
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA Phase III trial: “HIMALAYA is the first Phase III trial to add a novel single priming dose of an anti-CTLA4 antibody to another checkpoint inhibitor, durvalumab. This serves to boost the patient’s own immune system against their liver cancer, aiming to maximise long-term survival with minimal side effects. This is very exciting news for our patients.”
The data from the HIMALAYA Phase III trial is to be presented at an upcoming medical meeting.
Both Imfinzi and tremelimumab were granted orphan drug designations in the US in 2020 for the treatment of HCC, while the latter was granted orphan designation in the EU in the same year.