Real-life data on [177Lu]Lu-PSMA-617: Descriptive analysis on the largest metastatic castration-resistant prostate cancer (mCRPC) cohort treated in France

• Published in: Journal of clinical oncology Vol. 42; no. 4_suppl; p. 129
• Main Authors: Somme, François, Barthelemy, Philippe, Olivier, Pierre, Massard, Vincent, Giraudet, Anne Laure, Flechon, Aude, Girault, Sylvie, Abadie Lacourtoisie, Sophie, Bailly, Clément, Viala, Caroline, Godbert, Yann
• Format: Journal Article
• Language: English
• Published: American Society of Clinical Oncology 01.02.2024
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2024.42.4_suppl.129

129Background: VISION study showed that [177Lu]Lu-PSMA-617 added to BSoC prolonged imaging-based progression-free survival and overall survival in patients (pts) with PSMA-positive mCRPC. French Health Authorities has granted a "cohort" early access for [177Lu]Lu-PSMA-617 in this indication. Methods: PSMA positive mCRPC pts pretreated with at least 1 taxane-based chemotherapy regimen and ≥1 androgen receptor pathway inhibitor (ARPI) were included. [177Lu]Lu-PSMA-617 (7.4 GBq) was administered up to 6 cycles every 6 weeks. Pts' characteristics and safety data are described for the entire population. Efficacy was analyzed within a sub-population with 6 months follow-up min after 1st [177Lu]Lu-PSMA-617 injection. Adverse events (AE) grading was not evaluated. Results: From 12/1/2021 to 6/30/2023, 945 pts were included, and 535 pts were analyzed for efficacy. At data cut-off, 474 were still under treatment, and 471 stopped treatment due to disease progression (50.1%), AE (7.2%) or death (7.4%). 124 pts (26.3%) completed all 6 injections. Pts baseline characteristics: median age 73.2 (44-92) years; ECOG 0-1: 86.3%; median PSA level 70.9 (0.1 -6972) ng/ml; metastatic sites: bone 93.8%, lymph node 62.4%, liver 10.7%; previous taxane regimen: 97.1% of which 61.6% have received 2; prior ARPI treatment: 100% and 66.6% received 2 or more (median: 2). Concomitant treatment with ARPI was observed in 26.8%. In terms of efficacy results, the best imaging response was assessed by investigators (by RECIST 1.1 and PCWG3 on CT/bone scan and/or metabolic responses PET PSMA): 1.2% CR, 35.7% PR, 26.7% SD. 68.1% pts had a decrease in PSA level at any time point. Median time to PSA decrease was 1.22 (0.1-9.6) months. 12.8% (n= 121) of pts experienced >1 treatment-related (TR) AE, including 99 pts with ≥1 serious AE. 3 fatal cases related to treatment have been reported. The most reported TRAEs were thrombocytopenia (5.4% of pts) and anemia (5.0% of pts). Conclusions: In this large real-life cohort of mCRPC treated with [177Lu]Lu-PSMA-617 pts are heavily pretreated, received less concomitant ARPI treatment and higher incidence of 2 prior taxane regimens compared to VISION study. Safety profile of [177Lu]Lu-PSMA-617 remains favorable. Since the cohort is still ongoing, updated results will be presented at ASCO GU congress, including longer follow-up period and higher number of pts who completed treatment.