AstraZeneca Plc (AZN.L,AZN) said Friday that results from the global Phase II Study 22 trial testing the company’s tremelimumab added to IMFINZI (durvalumab) demonstrated promising clinical activity and tolerability in patients with advanced hepatocellular carcinoma or HCC.
Tremelimumab is an anti-CTLA4 antibody and potential new medicine. HCC is the most common type of liver cancer.
Study 22 is an open-label, multicenter, global, four-part Phase II trial evaluating the safety and efficacy of several treatments in 433 patients with advanced HCC in the 1st- or 2nd-line setting.
AstraZeneca noted that in the primary endpoint of the trial evaluating safety, all experimental arms showed an acceptable profile and no new safety signals were identified.
Patients treated with a single, priming dose of tremelimumab 300mg added to durvalumab every four weeks (T300+D regimen) achieved a median overall survival or OS of 18.7 months in a key secondary endpoint.
The OS result for the T300+D regimen was the longest among treatments tested in the trial, which included IMFINZI monotherapy, tremelimumab monotherapy and two regimens of the two combined.
In other key secondary endpoints, objective response rate or ORR confirmed by independent central review was 24 percent with the T300+D regimen, and median duration of response or DoR was not yet reached at the time of data cut-off.
A unique T-cell profile for patients in the T300+D arm was associated with treatment response, suggesting complementary biological activity.
Kate Kelley, Associate Professor of Clinical Medicine of the Department of Medicine, University of California San Francisco, and principal investigator said, “In Study 22, we were able to induce a stronger immune response and enhance the clinical activity of IMFINZI in patients with advanced liver cancer by combining with a single dose of tremelimumab, a novel approach designed to prime the immune response using CTLA-4 inhibition at the start of therapy.”
Kelley added that the results suggested dual checkpoint blockade with tremelimumab and IMFINZI may have a role in a challenging cancer where patients have few treatment options.
Source: Read Full Article