medwireNews: Supplementing standard of care (SOC) treatment with lutetium-177-prostate-specific membrane antigen-617 (LuPSMA) significantly boosts the outcomes of heavily pretreated men with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), say the VISION investigators.
As reported at the 2021 ASCO Annual Meeting, the alternate primary endpoints of radiographic progression-free survival (PFS) and overall survival (OS) were both significantly prolonged with the addition of LuPSMA to SOC in patients who had previously received at least one next-generation androgen receptor signaling inhibitor and up to two chemotherapy regimens.
“The findings suggest that [LuPSMA] warrants consideration as a new standard of care in this patient population, pending regulatory review and approval,” study author Michael Morris (Memorial Sloan Kettering Cancer Center, New York, USA) commented in a press release.
Michael Morris discusses the VISION trial findings demonstrating a survival benefit with LuPSMA-targeted therapy for men with heavily pretreated metastatic castration-resistant prostate cancer (7:44).
The 831 participants of the open-label phase 3 study were randomly assigned to receive SOC either with or without four to six cycles of LuPSMA at a dose of 7.4 GBq every 6 weeks. The SOC treatment was chosen by the physician but excluded cytotoxic chemotherapy and radium-223.
After a median follow-up of 20.9 months, the risk for radiographic progression or death was a significant 60% lower in the LuPSMA than the control group, with median radiographic PFS durations of 8.7 and 3.4 months, respectively.
The risk for death was also significantly reduced with the addition of LuPSMA to SOC, by 38% relative to SOC alone. The respective median OS times were 15.3 and 11.3 months.
Treatment with the combination of LuPSMA and SOC also significantly improved all key secondary endpoints versus SOC alone, said the presenting author, with higher rates of objective response and disease control, at 29.8% versus 1.7% and 89.0% versus 66.7%, respectively, and a longer time to first symptomatic skeletal event, at a median of 11.5 versus 6.8 months.
Morris noted that adverse events (AEs) “were more common with [LuPSMA] but none were unexpected.”
Grade 3–5 AEs were observed in 52.7% of patients who received LuPSMA plus SOC and 38.0% of those given SOC alone. The most common of these events was bone marrow suppression, occurring in 23.4% and 6.8%, respectively, followed by fatigue (7.0 vs 2.4%), kidney effects (3.4 vs 2.9%), and nausea and vomiting (1.5 vs 0.5%).
In conclusion, Morris highlighted that “there are ongoing studies in patients with prostate cancer at earlier phases of the disease using this agent.”
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