MediMix is honored to bring an exclusive interview with Dr. Oliver Sartor, a renowned medical oncologist from Mayo Clinic, Rochester, MN. He had the privilege of discussing the PSMAfore trial during the presidential session at ESMO.
Trial design
PSMAfore is a phase 3 trial involving 177Lu-PSMA-617, a targeted radioligand therapy for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). This trial included taxane-naive mCRPC patients who were candidates for androgen receptor pathway inhibitors (ARPI) change after one progression on prior ARPI and who showed PSMA PET positivity after conducting a PSMA PET scan.
Randomization was 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq every 6 weeks for 6 cycles) or ARPI change (abiraterone or enzalutamide). Importantly, patients randomized to ARPI could crossover to 177Lu-PSMA-617 following centrally reviewed radiographic progression.
Results
The primary endpoint, radiographic progression -free survival (rPFS) was strongly positive with 177Lu-PSMA-617, with a hazard ratio of 0.43. Patients receiving 177Lu-PSMA-617 had an objective response rate of 50.7% tumour shrinkage. The PSA response rate was 57.6%. Patients also reported improvements in their time to deterioration, health-related quality of life and pain. Time to symptomatic skeletal related adverse events also favored the 177Lu-PSMA-617 arm. The treatment was well tolerated. Patients who progressed on the hormonal arm could crossover to the 177Lu-PSMA-617 arm and 84.2% of patients did. The crossover adjusted overall survival analysis has a ratio of 0 .8, but the conference intervals crossed one.
Summary
Dr. Sartor concluded that 177Lu-PSMA-617 is a very active agent. The adverse event profile was very favorable, even better than the secondary hormonal treatment. He is confident that 177Lu-PSMA-617 will be a treatment option for taxane -naive mCRPC patients in the future.
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