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Al B. Benson III, MD, FACP, FASCO

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Durvalumab Plus Tremelimumab Receives FDA Approval in Treatment of Advanced Liver Cancer

By: JNCCN 360 Staff
Posted: Monday, October 24, 2022

Today, the U.S. Food and Drug Administration (FDA) approved a combination of immunotherapy agents—durvalumab (Imfinzi) and tremelimumab (Imjudo)—for the treatment of adults with unresectable hepatocellular carcinoma. The approval, which is based on the results of the phase III HIMALAYA trial, includes a novel dose and schedule called the STRIDE regimen.

The HIMALAYA trial involved 1,117 patients with unresectable hepatocellular carcinoma who had received no previous systemic treatment. They received one of three regimens: a single dose of tremelimumab (300 mg, one dose) plus standard dosing of durvalumab (1,500 mg every 4 weeks; STRIDE regimen), durvalumab (1,500 mg every 4 weeks); or sorafenib (400 mg twice daily). According to the results of the international study, the 36-month overall survival rates were 30.7% with the combination immunotherapy, compared with 24.7% with durvalumab alone and 20.2% with sorafenib alone. Thus, the combination immunotherapy lowered the risk of death by 22%.

“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,” stated Memorial Sloan Kettering Cancer Center gastrointestinal medical oncologist Ghassan Abou-Alfa, MD, MBA, principal investigator of the HIMALAYA trial, in a press release.

Durvalumab also was recently approved to treat patients with advanced biliary tract cancer in the United States based on the results of the phase III TOPAZ-1 trial. In addition, durvalumab was approved in the curative-intent setting of unresectable, stage III non–small cell lung cancer for patients whose disease has not progressed after chemoradiotherapy.


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