Neal Shore, MD, FACS, reviews the VISION clinical trial in prostate cancer imaging.
Neal Shore, MD, FACS: I don’t know that we want to go into a lot of discussion on it, but we alluded to this earlier, the importance of PSMA [prostate-specific membrane antigen] PET [positron emission tomography] vis-à-vis the enhancement of diagnostic imaging. Then there is the second component of bringing in the PSMA antibody conjugates with a radiopharmaceutical in the form of a beta particle. This is the VISION trial, utilizing lutetium and PSMA for patients who were PSMA positive, and 87% of the patients at baseline had a positive PSMA scan. This was in a group of patients who were heavily pretreated with prior taxane, 1 or 2 novel hormonal agents [NHAs], and then were randomized to Lu-PSMA-617 vs best standard of care, but a taxane, cabazitaxel, was not part of this. But even with this caveat, this was probably the most important data that came out of the ASCO 2021 [American Society of Clinical Oncology annual meeting] and essentially demonstrated that the primary analysis, the rPFS [radiographic progression-free survival], and I will show in a second the OS [overall survival], hit their end points with a statistically significant hazard ratio. Here on the rPFS, it is 0.4, in a heavily pretreated and high tumor burden population. Here is the OS primary end point, also demonstrating its significance.
What’s interesting and important now is what we talked about, theragnostics. Most of us are expecting this will lead to FDA approval for patients with mCRPC [metastatic castration-resistant prostate cancer] post-chemotherapy, post-NHA. We expect this approval to certainly happen in the very near term, and this will open the flood gates for other important trials looking at both other beta particles and alpha particles in the form of, most classically used globally would be actinium. There are others even combining beta and alpha particles, and even small molecules as well. This is an exciting area that our colleagues need to stay tuned for. Much like PSMA PET, it’s not about if, it’s only when you will be utilizing this novel mechanism of action strategy. Like in VISION and so many other advanced prostate cancer therapeutics, it will start to be interrogated prechemotherapy and even within metastatic castration-sensitive disease.
Transcript edited for clarity.