FDA Accepts BLA for Liver Cancer Therapy Tremelimumab

The FDA has set a Prescription Drug User Fee Act date for tremelimumab during the fourth quarter of 2022.

The FDA has accepted AstraZeneca’s biologics license application (BLA) for tremelimumab for priority review. If approved, it will be used as a single priming dose of the anti-CTLA4 antibody added to the company’s Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). A supplemental BLA has also been submitted for Imfinzi in this indication. This novel dose and schedule of the combination is called the STRIDE regimen.

The FDA has set a Prescription Drug User Fee Act date during the fourth quarter of 2022.

The application is supported by results from the HIMALAYA phase 3 trial. Investigators found that a single priming dose of tremelimumab plus Imfinzi every four weeks reduced risk of death by 22% in patients who had not received prior systemic therapy and were not eligible for localized treatment.

The results also showed an increase in objective response rate with this regimen compared with Bayer/Onyx’s Nexavar (sorafenib) (20.1% vs. 5.1%). Median duration of response was 22.3 months compared with 18.4 with sorafenib. The addition of tremelimumab to Imfinzi did not increase severe liver toxicity, and no bleeding risk was observed.

Imfinzi and tremelimumab were granted orphan drug designation for the treatment of HCC in January 2020.

“Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the United States as soon as possible,” Susan Galbraith, Ph.D., executive vice president, Oncology R&D at AstraZeneca, said in a press release.

HCC is the most common type of liver cancer. About 26,000 people in the United States present with advanced, unresectable HCC each year.

AstraZeneca also is conducting trials of Imfinzi in locoregional HCC and as adjuvant therapy for HCC.