UK — AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The combination’s dosing regimen has been dubbed the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen, and it consists of a single dose of Imjudo 300mg added to Imfinzi 1500mg, followed by Imfinzi every four weeks.
The approval takes Imjudo, a CTLA4 inhibitor into uncharted territory in HCC, as BMS’ Yervoy plus Opdivo is only FDA-approved as a second-line treatment after sorafenib, also known as Nexavar, and available as a generic.
AZ sees the first-line HCC indication as a significant opportunity for its immuno-oncology franchise, so it used a priority review voucher – typically valued at around US$100 million – to reduce the FDA review time for the application to six months.
The approval is based on findings from the HIMALAYA Phase III trial, which found that a single priming dose of the anti-CTLA-4 antibody Imjudo combined with the anti-PD-L1 antibody Imfinzi reduced the risk of death by 22% compared to sorafenib.
The findings were also published in the New England Journal of Medicine Evidence, revealing that an estimated 31% of patients treated with the combination were still alive after three years, compared to 20% of patients treated with sorafenib at the same time.
The safety profiles of Imjudo added to Imfinzi and Imfinzi alone were consistent with the known profiles of each medicine, according to the company, and no new safety signals were identified.
HCC is a complicated and heterogeneous tumor that is most often associated with underlying chronic liver disease, particularly hepatitis.
HCC accounts for approximately 75% of all primary liver cancers in adults, with more than half of patients being diagnosed at advanced stages of the disease, often when symptoms first appear.
Liver cancer is the third leading cause of cancer death and the sixth most common cancer diagnosed globally.
According to AstraZeneca, it is the fastest-growing cause of cancer-related deaths in the United States, with approximately 36,000 new diagnoses each year.
One rival to Imjudo/Imfinzi in previously untreated HCC is Roche’s dual regimen of PD-L1 inhibitor Tecentriq (atezolizumab) and CD20-targeting antibody Avastin (bevacizumab), which was approved by the FDA in 2020 based on the IMbrave150 study results.
Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan, and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results, AstraZeneca said.
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