Encouraging Data for Novartis’ 225Ac-PSMA-617 in mCRPC, Xerostomia Risk
NVS•Novartis presented Phase I AcTION data for its actinium-based RLT 225Ac-PSMA-617 in mCRPC at ASCO 2026, highlighting encouraging efficacy signals and readiness for high-potency alpha emitter supply. Noted irreversible dry mouth from salivary gland radiation underscores critical benefit–risk evaluation.
1. Phase I AcTION Trial Data
At ASCO 2026, Novartis unveiled initial findings from its Phase I AcTION trial evaluating the actinium-based radioligand therapy 225Ac-PSMA-617 in men with metastatic castration-resistant prostate cancer. Early assessments indicated promising tumor response rates, supporting further exploration of alpha-emitter potency and dosing strategies.
2. Xerostomia and Safety Profile
A significant proportion of patients experienced irreversible dry mouth due to radiation accumulation in salivary glands, highlighting an on-target off-tumour adverse event that can impair quality of life. This finding stresses the importance of patient selection, mitigation strategies and long-term salivary function monitoring.
3. Alpha Emitter Supply and Development
Novartis is leveraging its established infrastructure from Pluvicto’s beta-emitter program to build a resilient supply chain for alpha isotopes. Analysts emphasize that maintaining isotope availability and optimizing benefit–risk assessments will be crucial for positioning 225Ac-PSMA-617 earlier in treatment pathways.
