Imfinzi + Imjudo approved in the EU for patients with advanced liver and non-small cell lung cancers

The approvals authorise Imfinzi in combination with Imjudo for the 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) and Imfinzi in combination with Imjudo and platinum-based chemotherapy for the treatment of adult patients with metastatic (Stage IV) non-small cell lung cancer (NSCLC) ( for NSCLC see separate entry). The two approvals by the European Commission follow positive recommendations by The Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022 and are based on positive results from the HIMALAYA Phase III trial, published in the New England Journal of Medicine Evidence (previously cited) and the POSEIDON Phase III trial, published in the Journal of Clinical Oncology (previously cited).

Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, and a lead investigator in the HIMALAYA Phase III trial, said: “This approval in Europe is welcome news for eligible patients with advanced liver cancer, who face a poor prognosis and are in need of well-tolerated treatments that can meaningfully extend overall survival. In HIMALAYA, an estimated 31% of patients treated with this novel combination of tremelimumab with durvalumab were alive at three years, while only 20% of patients treated with sorafenib were still alive at the same duration of follow-up.”

Imjudo and Imfinzi approved in liver cancer The approval for the treatment of HCC is based on results from the HIMALAYA Phase III trial, where the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen, comprised of a single dose of the anti-CTLA-4 antibody Imjudo (300mg) combined with anti-PD-L1 antibody Imfinzi (1500mg dose) followed by Imfinzi every four weeks significantly reduced the risk of death by 22% versus sorafenib (hazard ratio [HR] 0.78; 95% confidence interval [CI], 0.66-0.92; p=0.0035). Median overall survival (OS) was 16.4 months versus 13.8 for sorafenib. An estimated 31% of patients treated with the combination were still alive after three years with 20% of patients treated with sorafenib still alive at the same duration of follow-up.

The safety profile of the combination of Imjudo added to Imfinzi were consistent with the known profiles of each medicine, and no new safety signals were identified.

Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1,2 Approximately 87,000 Europeans were diagnosed with liver cancer in 2020, with 51% of patients at an advanced cancer stage at time of diagnosis. Rates of liver cancer continue to rise rapidly, with a 70% increase of liver cancer-related mortality in Europe from 1990-2019.