Those following information coming from the ESMO Congress over the last few weeks will be aware of the many presentations focussed on the use of Lutetium.
PSMAfore Study Unveils Game-Changing Results for Prostate Cancer Treatment
One such highlight was the results from the PSMAfore study – a phase three trial exploring PSMA -617 lutetium for taxane-naïve patients with metastatic castrate-resistant prostate cancer. Results of this study are discussed in the special UroToday presentation with Oliver Sartor.
Notable findings revealed significantly improved radiographic progression free survival with PSMA-617 lutetium vs a change in androgen receptor pathway inhibitors – some 12.02 months v 5.59 months in the control group plus extended time to symptomatic skeletal events, enhanced QOL and fewer adverse events in the lutetium arm.
Dr Sartor also noted the substantial crossover to lutetium when progression occurred in the control arm and acknowledged, although the overall survival data is immature, there is some indication that for this group there is a survival benefit with lutetium, meaning that even if there are delays in transitioning to lutetium there may still be benefits.
urotoday.com/trials-in-prog...
Enzalutamide and 177Lu-PSMA-617 in Poor Risk Metastatic Castrate Resistant Prostate Cancer (mCRPC) – ENZA-p study
The presentation of the results of this trial by Dr Louse Emmett, director of theranostics and nuclear medicine at St Vincent’s Hospital in Sydney, will be of interest generally to those who ‘sit’ in this high-risk group. It will also be special interest to those of us in Australia where Lutetium is not funded either by Medicare or private insurance regardless of whether you are castrate sensitive or resistant. An issue Dr Emmett is trying hard to rectify.
This phase 2 randomised trial of Enzalutamide and Lu-PSMA-617, in poor risk mCRPC evaluated the activity and safety of combining enzalutamide with adaptive dosing of LuPSMA vs enzalutamide alone as first line treatment for mCRPC. Participants had not previously been treated with chemotherapy or androgen receptor pathway inhibitors although prior treatment with abiraterone and/or docetaxel for hormone sensitive disease were allowed.
During the presentation Dr Emmett commented “This is the first randomized trial combining an androgen receptor signalling inhibitor, enzalutamide, with Lu-PSMA-617. It provides strong evidence for an enhanced anti-cancer effect with the combination of enzalutamide and Lu-PSMA-617 based on the primary end point, PSA-PFS”. Data from the study showed a median PSA-PSF of 13 months with the combination therapy compared with 7.8 months with enzalutamide alone. Median radiographic PFS was 16 months with the combination therapy compared with 12 months for enzalutamide. Additionally, decreases in PSA >50% response rates were 93% in the combination arm compared with 68% for enzalutamide alone.
Dr Emmett noted “We used 2 to 4 doses of Lu-PSMA in the ENZA-p trial, but 2 to 6 doses may further improve progression free survival, particularly in those patients who have a high proportion of androgen persistent clones.”
If this trial is of particular interest to you, a podcast interview with Dr Emmett by Dr Declan Murphy is expected in the next week.
Determinants of PSA Response to Bipolar Androgen Therapy [BAT]