Earlier treatment with Pluvicto may be beneficial for patients with hormone-sensitive prostate cancer
New late-stage clinical trial findings signal that treatment with Pluvicto—a targeted radiotherapy for prostate cancer—may benefit more patients than previously believed.
Swiss drugmaker Novartis shared the topline outcomes from Phase 3 of the PSMAddition trial, which is assessing Pluvicto’s efficacy in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The drug has shown a “clinically meaningful benefit” in these patients, suggesting its potential as an earlier treatment option than what it is currently indicated for, Novartis reports.
The trial has met its primary endpoint—radiographic progression-free survival, with a positive trend in overall survival when treatment plans include Pluvicto in addition to hormone therapy. This finding is important, as almost all mHSPC patients eventually progress to metastatic disease that is castration resistant.
“The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients," Novartis Chief Medical Officer Shreeram Aradhye, MD, said in a news release on the new findings. "These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy."
In March, the FDA approved Pluvicto for use prior to chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. The specifics of these latest results pertaining to mHSPC are set to be presented during an upcoming medical conference, and Novartis plans to submit the data for regulatory review in the second half of 2025.
Learn more about the results here.