Dr. Sartor shares phase 3 trial data on 117Lu-PSMA-617 in mCRPC

In this video, Oliver Sartor, MD, highlights findings from the phase 3 PSMAfore (NCT04689828) trial exploring ¹⁷⁷Lu-PSMA-617 in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC), which he presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. Sartor is the director of radiopharmaceutical trial at Mayo Clinic in Rochester, Minnesota.

Video Transcript:

The primary end point of rPFS was met in a primary analysis, the hazard ratio 0.41. We had a secondary analysis presented here; hazard ratio is 0.43, essentially the same. Confidence intervals were small, did not overlap 1. If we want to look at the quantitative estimates, the medians were about 12.02 months for the ¹⁷⁷Lu-PSMA-617, 5.59 months for the secondary hormone. Again, those are significant differences, more than doubling in the rPFS.

Then, of course, we had a whole variety of secondary end points. Among the secondary end points was a crossover adjusted overall survival (OS). That came out at a hazard ratio 0.8. Those confidence intervals are still pretty big; they did overlap 1. So, not a statistically significant crossover adjusted OS. Then we looked at a whole bunch of other things like health-related quality of life –that was better with ¹⁷⁷Lu-PSMA-617. We looked at time to PSA, time to pain progression – that was better with ¹⁷⁷Lu-PSMA-617. We looked at PSA decline rates – that was better with ¹⁷⁷Lu-PSMA-617. Objective responses were better with ¹⁷⁷Lu-PSMA-617. [We] looked at the symptomatic skeletal events – that was better with ¹⁷⁷Lu-PSMA-617. And [we] looked at adverse events, and adverse events were better with ¹⁷⁷Lu-PSMA-617. So, we had a whole litany of end points that are positive with lutetium, as compared to secondary hormones. The surprise to me was the grade 3/4 adverse events better with ¹⁷⁷Lu-PSMA-617, SAEs better with ¹⁷⁷Lu-PSMA-617, and dose adjustments [were] better with ¹⁷⁷Lu-PSMA-617. So, the hormones were adjusted in dose about 50% of the time, and ¹⁷⁷Lu-PSMA-617 was only about a third of that. That was surprising. Discontinuation rates [were] small, about 5% in each arm.

This transcription has been edited for clarity.