An immunotherapy combining the drugs Imfinzi (durvalumab) and Imjudo (tremelimumab) receives European Commission approval for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) and metastatic (stage 1) non-small cell lung cancer (NSCLC). IV) without sensitizing EGFR mutations or ALK-positive mutations.
These approvals follow the positive recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency of December 2021, which have been based on the significant survival benefits revealed by the HIMALAYA phase III clinical trials – published in New England Journal of Medicine Evidence– and POSEIDON – published in the Journal of Clinical Oncology–.
Longer survival with the new therapeutic combination
Liver cancer is the third leading cause of cancer death and the sixth most frequently diagnosed cancer in the world. In 2020, some 87,000 Europeans were diagnosed with liver cancer and in 51% of them the tumor was at an advanced stage. About 75% of all primary liver cancers in adults are HCC and about 80-90% of patients with HCC also have cirrhosis. In the HIMALAYA trial, 30.7% of 1,171 patients treated with the new immunotherapy combination were alive at three years, compared with 20.2% of patients treated with sorafenib.
“Immunotherapy shows us every day that we are no longer treating just one type of cancer, but that we are trying to advance in the approach to cancer in general, with the ambition of eliminating it as a cause of death”
As for lung cancer, it is the leading cause of cancer-related death and is the second most common form of cancer in the world and more than two million people were diagnosed with this type of cancer in 2020. The POSEIDON study showed that a regimen limited to five cycles of anti-CTLA-4 antibody added to durvalumab plus four cycles of platinum-based chemotherapy decreased the risk of death by 23% compared with various chemotherapy options.
Dr. Bruno Sangro, director of the Liver Unit of the Clínica Universidad de Navarra (CUN), Professor of Internal Medicine at the Faculty of Medicine of the University of Navarra and principal investigator in the HIMALAYA trial, has stated that “this approval in Europe is good news for eligible patients with advanced liver cancer, who face a poor prognosis and need well-tolerated treatments that can significantly increase overall survival.”
For her part, Dr. Solange Peters, Head of the Medical Oncology Service and Chair of Thoracic Oncology at the Hospitalier Universitaire Vaudois, in Lausanne, Switzerland, and principal investigator in the POSEIDON trial, highlighted that “patients with lung cancer Non-small cell metastatic patients continue to need new therapies that may extend their survival, including many patients who do not respond to current therapies. The approval of this combination and chemotherapy means that patients in Europe with this devastating cancer now have a new treatment with proven survival benefits.”
Ramón Mel, Director of Oncology at AstraZeneca Spain, stated that “both approvals give a good example of the change in the approach to cancer patients. Immunotherapy shows us every day that we are no longer treating just one type of cancer, but that we are trying to advance step by step in the approach to cancer in general, with the ambition of eliminating it as a cause of death. In addition, the results of the Phase III HIMALAYA and POSEIDON trials give us more time to continue our research and get closer to that goal every day.”
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