Oliver Sartor, MD
Oliver Sartor, MD, Assistant Dean for Oncology and Professor at the Tulane University School of Medicine, New Orleans, commended Dr. Hofman and colleagues for completing a randomized phase II trial of lutetium-177–labeled prostate-specific membrane antigen (PSMA-617), or LuPSMA, so quickly. He said he was cautiously optimistic that the phase III VISION trial will bear out the results of TheraP. (Dr. Sartor and Bernd J. Krause, MD, are co–primary investigators of the VISION trial.)
“We are very enthusiastic about the phase II results, but these data are not sufficient to sway regulators for approval. The key trial is the VISION trial, which completed accrual in January, but the results have not been analyzed yet. We can look forward to presentation of the data later in 2021. If that trial is positive, it is reasonable to expect [U.S. Food and Drug Administration] approval in the post-taxane space. Thus far, we believe patients will benefit from [LuPSMA],” Dr. Sartor said.
“[LuPSMA] will be competitive with cabazitaxel as third-line therapy, as established by the CARD study,” he noted. “The TheraP trial was well conducted, used an active comparator [cabazitaxel], and clearly showed positive results in a number of meaningful endpoints. This gives us hope that larger trials will be positive.”
When asked whether there are competitors for LuPSMA, Dr. Sartor named four other PSMA-targeted compounds under development: lutetium-177–PNT2002; iodine-131–1095; copper-67–PSMA; and thorium-277–PSMA. “Each of these compounds has a solid rationale. We don’t know how they will stack up against one another,” he said.
DISCLOSURE: Dr. Sartor has served as a consultant or advisor to Novartis, Noria Therapeutics, Point Biopharma, Clarity, Lantheus, and Bayer.
Following disease progression on docetaxel, prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy reduced the risk of disease progression or death by 37% vs cabazitaxel in men with metastatic castration-resistant prostate cancer in the TheraP phase II trial reported at the 2021...