AstraZeneca announces HIMALAYA trial demonstrated overall survival benefit

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi plus Imjudo demonstrated a sustained, clinically meaningful overall survival, or OS, benefit at five years for patients with unresectable hepatocellular carcinoma, or HCC, who had not received prior systemic therapy and were not eligible for localized treatment. These results from HIMALAYA will be presented today at the European Society for Medical Oncology, or ESMO, Congress in Barcelona, Spain. At five years of follow-up, this latest exploratory analysis showed that a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen, reduced the risk of death by 24% compared to sorafenib. An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% for those treated with sorafenib. In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response, or DpR showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib. The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, and no new safety signals were observed with longer follow-up. Serious treatment-related adverse events, defined as Grade 3 or 4 and including death, were experienced by 17.5% of patients treated with the STRIDE regimen versus 9.9% of patients treated with sorafenib, with no new events occurring after the primary analysis for STRIDE. Imfinzi in combination with Imjudo is approved for the treatment of adults with advanced or unresectable HCC in the U.S., EU, Japan and several other countries. Imfinzi monotherapy is also approved in Japan in this setting.