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FDA Alerts
Oncology

FDA approves tremelimumab/durvalumab combo for unresectable HCC

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The U.S. Food and Drug Administration has approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adults with unresectable hepatocellular carcinoma (HCC).

The novel dose and scheduling, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), includes a single dose of the anti-CTLA-4 antibody tremelimumab 300mg added to the anti-PD-L1 antibody durvalumab 1500 mg followed by durvalumab every 4 weeks.

Approval for the treatment was based on results from the Phase 3 HIMALAYA trial which found patients receiving the combination treatment had a 22% reduction in the risk of death versus sorafenib. At 3 years follow-up, approximately 31% of patients treated with the combination were still alive compared with 20% of those treated with sorafenib.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. 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,” said Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase 3 trial.

Read the full press release here.

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