AstraZeneca's Tremelimumab/Imfinzi Combo Regime Goes Under Priority FDA Review For Liver Cancer

The FDA has accepted for review AstraZeneca Plc's AZN marketing application for tremelimumab as a single priming dose added to Imfinzi (durvalumab) for unresectable hepatocellular carcinoma (HCC).
This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
A supplemental marketing application has also been submitted for Imfinzi in this indication.
Also Read: AstraZeneca's Imfinzi Flunks In Late-Stage Advanced Cervical Cancer Study.
Under priority review status, the Prescription Drug User Fee Act date is during Q2 of 2022.
The BLA for tremelimumab and sBLA for Imfinzi is based on final results from the HIMALAYA Phase 3 trial presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
In this trial, patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib.
Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.
The safety profiles of the STRIDE regimen and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified.
Price Action: AZN shares are down 1.78% at $64.69 during the premarket session on Monday's last check.