Radioligand Therapy effective in PSMA positive Castration-Resistant Prostate Cancer: NEJM

All the selected participants were randomly divided into two groups in a 2:1 ratio to receive either ¹⁷⁷Lu-PSMA-617 and routine standard care or standard care alone. The standard care excluded chemotherapy, immunotherapy, radium-223 (²²³Ra), and investigational drugs.

The alternate primary endpoints were imaging-based progression-free survival and overall survival, which were powered for hazard ratios of 0.67 and 0.73, respectively.

Key secondary endpoints were objective response, disease control, and time to symptomatic skeletal events.

Adverse events during treatment were those occurring no more than 30 days after the last dose and before following treatment against cancer.

The findings of the study are as follows:

· Lu-PSMA-617 and standard care significantly increased both imaging-based progression-free survival (median, 8.7 vs. 3.4 months; hazard ratio for progression or death, 0.40; 99.2% confidence interval [CI], 0.29 to 0.57; P<0.001) and overall survival (median, 15.3 vs. 11.3 months; hazard ratio for death, 0.62; 95% CI, 0.52 to 0.74; P<0.001)as compared to standard care alone.

· All the key secondary endpoints also favored ¹⁷⁷Lu-PSMA-617.

· The incidence of adverse events of grade 3 or above was higher with ¹⁷⁷Lu-PSMA-617 as compared to just standard care (52.7% vs. 38.0%).

· However, quality of life was not adversely affected.

The researchers concluded that radioligand treatment with ¹⁷⁷Lu-PSMA-617 increased both imaging-based progression-free survival and overall survival when used simultaneously with the routine care in patients with advanced PSMA-positive metastatic castration-resistant prostate cancer.

Reference:

A study titled, "Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer" by Sartor O et. al published in The New England Journal of Medicine

10.1056/NEJMoa2107322