Gary Ulaner, MD, PhD, FACNM, is the Director of Molecular Imaging and Therapy at Hoag Family Cancer Institute, as well as a Clinical Professor of Radiology and Translational Genomics, Keck School of Medicine, University of Southern California.
Dr. Ulaner sat down with us to explain the data that led to the FDA approval of 177Lu-PSMA-617 and the safety profile of this drug.
What are the data that led to the FDA approval of 177Lu-PSMA-617 (Pluvicto) and what is the safety profile of this drug?
Dr. Ulaner: I would mention two trials that I think should be known. The most critical and most highly cited is the VISION trial, published in the New England Journal of Medicine. Which was a randomized trial of patients receiving a standard of care, versus a standard of care plus this PSMA 617 bound to Lutetium-177 known as Pluvicto. And in that trial, there was a statistically significant survival advantage among patients receiving the Pluvicto, in the range of three to six months of survival improvement. Now that might sound pretty small, but for patients with metastatic prostate cancer, I can’t think of another FDA approved agent out there that has a survival advantage that supersedes that. This is really one of the most effective agents, as proven in clinical trials. That was an industry trial sponsored by Novartis with multiple institutions participating around the world.
A second trial that I note, came from Michael Hoffman’s group in Australia, which was a trial of the PSMA 617 labeled with Lutetium-177, versus a standard of care therapy. So, it was not a everyone gets the standard of care and then one group also gets the radioligand therapy. It was radioligand therapy versus the standard of care. And in that trial, remarkably, the radioligand therapy, what is now called Pluvicto, performed better than the current standard of care for patients with metastatic prostate cancer that have progressed on prior hormonal therapies.
So, two clinical trials. One demonstrating the addition is better than the standard of care alone, and the other demonstrating that the radioligand therapy is better than the standard of care. I think remarkable data supporting and leading to the FDA approval of Pluvicto.