Source – AstraZeneca
On 29 June 2023, new findings from the HIMALAYA Phase III trial revealed that AstraZeneca’s Imfinzi (durvalumab) combined with Im Judo (tremelimumab) provided a sustained and clinically significant overall survival (OS) benefit for patients with unresectable hepatocellular carcinoma (HCC) who hadn’t received prior systemic therapy and were ineligible for localized treatment.
These updated results from the HIMALAYA trial will be presented today at the 2023 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain.
After a four-year follow-up, the latest data demonstrated that a single priming dose of Im Judo, when added to Imfinzi (known as the STRIDE regimen – Single Tremelimumab Regular Interval Durvalumab), reduced the risk of death by 22% compared to sorafenib. Approximately 25.2% of patients treated with the STRIDE regimen were still alive after four years, compared to 15.1% of those treated with sorafenib. An additional exploratory analysis revealed that the effectiveness of the STRIDE regimen versus sorafenib remained consistent across all clinically relevant patient subgroups, including those who survived for at least three years, regardless of the underlying cause of the disease (hepatitis B virus [HBV], hepatitis C virus [HCV], or nonviral) or other baseline demographics.
“Historically, only seven per cent of patients with advanced liver cancer have survived five years, making the HIMALAYA long-term survival data especially meaningful. One in four patients treated with the STRIDE regimen were still alive at four years, reinforcing this novel regimen as a standard of care in this setting.”
– Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, Pamplona, Spain and a lead investigator in the trial
“The remarkable four-year survival benefit shown with Imfinzi and Imjudo in this advanced liver cancer setting supports the use of the STRIDE regimen to treat a broad, eligible patient population globally. These latest results from HIMALAYA are part of a series of clinical trials aiming to deliver innovative treatments for patients at different stages of liver cancer.”
– Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca
The safety profile of the STRIDE regimen remained consistent with the known profiles of each medication, and no new safety concerns were identified with longer follow-up. Serious treatment-related adverse events (TRAEs), defined as Grade III or IV and including fatal cases, were experienced by 17.5% of patients treated with the STRIDE regimen, compared to 9.6% of patients treated with sorafenib, with no new events occurring after the primary analysis for STRIDE (17.5%).
Imfinzi, in combination with Im Judo, has received approval for the treatment of adults with advanced or unresectable HCC in the US, EU (in the first-line setting), Japan, and several other countries. Imfinzi monotherapy is also approved in Japan for this indication.