MSK’s gastrointestinal medical oncologist Ghassan Abou-Alfa led the clinical trial that resulted in the FDA’s approval of a promising new combination therapy for hepatocellular cancer.
Patients with inoperable advanced liver cancer have a new option for treatment to extend their lives. Today the U.S. Food and Drug Administration (FDA) approved a combination of the immunotherapy drugs durvalumab (Imfinzi®) plus the experimental drug tremelimumab for people with unresectable hepatocellular cancer, the most common type of liver cancer.
The FDA approval was based on results of the clinical trial HIMALAYA involving 1,117 patients, led by gastrointestinal medical oncologist Ghassan Abou-Alfa at Memorial Sloan Kettering Cancer Center (MSK).
“This new therapy significantly improved overall survival for patients compared to what had been the standard of treatment,” says Dr. Abou-Alfa. “The prognosis for liver cancer has been a difficult challenge for doctors and our patients.”
- There are an estimated 42,000 adults diagnosed with primary liver cancer every year.
- Approximately 30,000 people die from the disease.
- The 5-year survival rate is 20.2%, based on 2012–2018 data.
The results from the international study showed after three years, about 30.7% of the patients who received the new combination immunotherapy were still alive, compared with 20.2% of the people who received only the kinase inhibitor drug sorafenib (Nexavar®). In the group given durvalumab alone, 24.7% were still alive.
In other words, the combination immunotherapy lowered the risk of death by 22%, according to the study.
How the New Combination Immunotherapy for Liver Cancer Works
Both immunotherapy drugs are checkpoint inhibitors — which means they help release the brakes cancer cells put on the immune system to prevent them from being destroyed.
Tremelimumab targets the CTLA-4 checkpoint. Durvalumab targets the PD-1 checkpoint. Patients received one dose of tremelimumab, followed by durvalumab, given intravenously every four weeks.
“The single dose of tremelimumab given at the beginning of the treatment theoretically jump-starts the immune system and improves the response to the durvalumab given once a month,” says Dr. Abou-Alfa.
About 25% of patients on the combination therapy experienced serious side effects, including skin problems, reduced liver function, and digestive issues. Patients taking sorafenib reported significantly more side effects. Those who took durvalumab alone had fewer.
Dr. Abou-Alfa first presented the results of the randomized phase 3 trial at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in June 2022.
The name for this new FDA-approved regimen is STRIDE. “It’s certainly a step in the right direction,” says Dr. Abou-Alfa. “While there is a heartbreaking need for more effective liver cancer treatments, this new immunotherapy combination can help more patients live longer and have a better quality of life.”
