Prostate cancer (Image source: hopkinsmedicine.org)
The VISION study enrolled 831 patients with mCRPC who had previously received taxane and androgen receptor-directed therapy (ARDT) and had progressed and had a positive PSMA-PET scan. In the study, these patients were randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group (n=551) received 177Lu-PSMA-617 (a intravenous infusion of 7.4 GBq every 6 weeks, up to 6 cycles) and SOC treatment, and the control group (n=280) only received SOC treatment. The primary endpoints of the study are radiological progression-free survival (rPFS) and overall survival (OS).
The results showed that the study reached two primary endpoints: Compared with SOC treatment, 177Lu-PSMA-617 combined with SOC treatment significantly prolonged OS and rPFS in PSMA-positive mCRPC patients. The specific efficacy data are: (1)In terms of OS, compared with the SOC group, the OS of the 177Lu-PSMA-617+SOC group was significantly improved (median OS: 15.3 months vs 11.3 months), and the difference in OS between the groups (4 months) was statistically significant ( Unilateral p<0.001), the risk of death is reduced by 38%(HR = 0.62 ; 95% CI: 0.52-0.74) ; (2)In terms of rPFS, compared with the SOC group, the rPFS of the 177Lu-PSMA-617+SOC group was significantly improved (median rPFS: 8.7 months vs 3.4 months), and the difference in OS between the groups (5.3 months) was statistically significant ( Unilateral p<0.001), radiological progression or risk of death reduced by 60%(HR = 0.40 ; 99.2% CI: 0.29-0.57)。
The study also reached key secondary endpoints: (1) The time to the first symptomatic skeletal event was significantly delayed. The median time to the first symptomatic skeletal event in the 177Lu-PSMA-617+SOC group was 11.5 months (95%). CI: 10.3, 13.2), while the SOC group was 6.8 months (95%CI: 5.2, 8.5) (HR=0.50; 95%CI: 0.40-0.62; bilateral p<0.0011. (2) Overall response rate (ORR) ) Has a significant improvement, and there are significant differences in ORR in patients with measurable or unmeasurable diseases at baseline examination (177Lu-PSMA-617+SOC group has a partial or complete remission rate of 29.8%, and SOC group has only a partial remission rate of 1.7 %; Bilateral p<0.001); (3) The disease control rate (DCR) has been significantly improved, 89.0% in the 177Lu-PSMA-617+SOC group and 66.7% in the SOC group (bilateral p<0.001).
In terms of safety, the incidence of drug-related adverse events (TEAE) reported during treatment in the 177Lu-PSMA-617+SOC group was higher than that in the SOC group (85.3% vs 28.8%). Regarding the discontinuation rate related to TEAE, 11.9% of patients in the 177Lu-PSMA-617+SOC group discontinued 177Lu-PSMA-617, 8.5% of patients discontinued SOC, and 7.8% of patients in the SOC group discontinued treatment.
177Lu-PSMA-617 (Image source: embs.org)
原文出处:Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study
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