MONDAY, June 7, 2021 (HealthDay News) — For previously treated metastatic castration-resistant prostate cancer (mCRPC) that is positive for prostate-specific membrane antigen (PSMA), 177Lu-PSMA-617 plus standard of care (SOC) improves radiographic progression-free survival (rPFS) and overall survival compared with SOC alone, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held virtually from June 4 to 8.
Michael J. Morris, M.D., from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues conducted a randomized phase 3 trial evaluating 177Lu-PSMA-617 in men with PSMA-positive mCRPC that was previously treated with antiandrogen therapy and chemotherapy. Participants were randomly assigned to 177Lu-PSMA-617 plus SOC or SOC alone (551 and 280, respectively). Participants had been followed for a median of 20.9 months at the time of the data cutoff.
The researchers found that rPFS was significantly improved with 177Lu-PSMA-617 and SOC versus SOC alone (median, 8.7 versus 3.4 months; hazard ratio, 0.40). There was also significant improvement in the alternate primary end point of overall survival (median, 15.3 versus 11.3 months; hazard ratio, 0.62). There was a statistically significant difference between the treatment arms in favor of 177Lu-PSMA-617 plus SOC for all key secondary end points. Therapy was well tolerated, although the rate of high-grade treatment-emergent adverse events was higher with 177Lu-PSMA-617 (52.7 versus 38 percent).
“The findings suggest that 177Lu-PSMA-617 warrants consideration as a new standard of care in this patient population, pending regulatory review and approval,” Morris said in a statement.
The study was funded by Endocyte Inc., a Novartis company; several authors disclosed ties to the pharmaceutical industry.
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