Adnkronos (Adnkronos) – “The phase 3 Himalaya study tested the immunotherapy combination of a single priming dose of tremelimumab combined with durvalumab (an anti-PD-L1 drug). This combination, the 'Stride regimen,' was evaluated against sorafenib, the standard of care. The study was positive, and as a result, the Stride regimen is now a standard first-line treatment option for patients with advanced, unresectable hepatocellular carcinoma.
The 5-year survival results represent a completely new finding, never before observed in advanced hepatocellular carcinoma. The study recorded a 5-year survival rate of approximately 20%, whereas historically, literature data for this population showed survival rates of less than 5%. Although these were selected patients enrolled in a clinical trial, this figure of approximately 20% had never been observed before, nor with other combinations.
Lorenza Rimassa, Professor of Medical Oncology at Humanitas University and Head of the Hepatobiliary Pancreatic Oncology Unit at the IRCCS Istituto Clinico Humanitas in Rozzano (Milan), stated this during a media tutorial on new frontiers in liver cancer treatment, promoted by AstraZeneca today in Milan.
“When considering patients who benefited from the treatment, that is, not only those with an objective response, but also those with stable disease, the percentage of patients alive at 5 years rises to 28%,” adds the expert. “These are unprecedented data, compared to other immunotherapy combinations, which confirm the Stride regimen as an extremely relevant therapeutic option for patients with advanced hepatocellular carcinoma.”
The positive data from the Stride regimen observed in the Himalaya study have also been confirmed in daily clinical practice. "In particular," the specialist explains, "we have an international data collection of real-life cases that has confirmed the findings in patients with similar characteristics to those enrolled in the Himalaya study. Furthermore, data from a local case series of patients treated with the Stride regimen in the Lombardy Region show a median survival rate even higher than that of the clinical study. Although these data do not yet have a very long follow-up, they clearly confirm the benefit for patients."
The efficacy of the Stride regimen was also confirmed by the Phase 3b Sierra study conducted on "a patient population typically excluded from Phase 2 registrational studies," the oncologist explains, "namely, patients with more complex and unfavorable prognostic and clinical characteristics already at the start of treatment. The extremely important finding from the Sierra study is that the tolerability profile of the Stride regimen was found to be comparable to that observed in the Himalaya study, even in the most fragile patients. The efficacy data were consistent with the objectives of the study, which was positive and was recently published in the Journal of Hepatology," she concludes.
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