The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
The drug also delivered a disease control rate (DCR) of 83.3% in high-dose cohorts and a mean progression-free survival of 6.3 months in SCLC patients
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
Benefits were consistent across all key subgroups, including patients previously treated with covalent BTK inhibitors
Highlights Mirvetuximab-based regimen promise
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival
The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy
The trial met its primary endpoint, with the combination therapy demonstrating a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival
The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI
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