The results of the US Phase III Vision Trial of 177Lu-PSMA-617 for mCRPC are finally being released at the 2021 ASCO virtual assembly starting tomorrow. Here is a preview (spoiler alert they are positively positive!)
The international, randomized Phase 3 VISION trial, led by investigators Dr. Michael Morris (Memorial Sloan Kettering Cancer Center) and Dr. Oliver Sartor (Tulane University), enrolled more than 800 patients with mCRPC whose disease had progressed on other treatments. Patients also had to have a positive PSMA PET scan, meaning that their prostate cancer cells showed the PSMA protein on the surface. Patients were randomized to treatment with 177Lu-PSMA-617 + best standard of care vs. best standard of care alone.
The study results were positive. Patients treated with 177Lu-PSMA-617 were approximately 40% less likely to die and 60% less likely to have disease progression on scans vs. patients treated with standard of care alone. Median overall survival was 15.3 months for patients in the 177Lu-PSMA-617 arm vs. 11.3 months in the standard of care alone arm. Other measures in the trial also showed a significant benefit for 177Lu-PSMA-617.
In terms of side effects, some were more common among patients treated with 177Lu-PSMA-617 + standard of care vs. standard of care alone. These included fatigue (49.1% vs 29.3%), bone marrow suppression (47.4% vs 17.6%), dry mouth (39.3% vs 1%), and nausea/vomiting (39.3% vs 17.1%).
177Lu-PSMA-617 has not been approved by the FDA, though this trial data will be used as part of an application for FDA approval.