AZN News & Events

The company states: "The global CARES Phase 3 clinical programme showed that treatment with anselamimab, a potential first-in-class anti-fibril therapy, resulted in nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain amyloidosis as first-line therapy added to standard of care plasma cell dyscrasia treatments, compared to placebo. In the overall population of patients with AL amyloidosis, treatment with anselamimab did not meet the primary endpoint, defined as a hierarchical combination of time to all-cause mortality and frequency of cardiovascular hospitalisations, as previously disclosed. In a prespecified subgroup analysis of patients with kappa predominant light chain isotype, anselamimab improved survival by 62%, measured by ACM , and reduced the frequency of CVH by 71% (incidence risk ratio 0.29; 95% CI 0.10, 0.87; nominal p=0.028), compared to placebo in the subgroup with kappa AL amyoidosis. The reduction in the risk of ACM in the kappa subgroup was also observed in both trials comprising the CARES Phase III clinical programme among patients with kappa isotype with Mayo stage IIIa disease (75%) and Mayo stage IIIb disease (48%). No differences in ACM and CVH were observed among patients with lambda predominant light chain isotype."

AstraZeneca's Imfinzi in combination with Bacillus Calmette-Guerin induction and maintenance therapy has been approved in the U.S. for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer.

The company states: "AstraZeneca's IMFINZI - or durvalumab - in combination with Bacillus Calmette-Guerin - BCG - induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, or NMIBC. The approval by the Food and Drug Administration is based on positive results from the POTOMAC Phase III trial which were presented at the European Society for Medical Oncology Congress 2025 and simultaneously published in The Lancet. In 2024, over 31,000 people in the US were treated for high-risk NMIBC, a curative-intent setting where the standard of care is tumor resection followed by BCG treatment directly into the bladder.1,2 About half of patients with NMIBC are at high-risk for disease recurrence or progression based on certain characteristics of their cancer, such as tumor grade, stage and specific tumor features.3 Up to 80% of high-risk patients experience disease recurrence within five years of treatment."

AstraZeneca's Imfinzi in combination with Bacillus Calmette-Guerin induction and maintenance therapy has been approved in the U.S. for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, the company announced. Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today's approval for Imfinzi brings the first immunotherapy combination regimen to patients in the US with BCG-naive, high-risk non-muscle-invasive bladder cancer, an early setting that builds on the positive impact Imfinzi is already having in muscle-invasive disease. The early and sustained disease-free survival benefit demonstrated by Imfinzi plus BCG in the POTOMAC trial is an important advance for patients at risk of early disease recurrence and signals a shift in the standard of care."