Real-life Analysis of [177Lu]Lu-PSMA-617 on mCRPC Patients cohort treated in France
Roubaud 1, F. Somme 2, P. Barthélémy 3, P. Olivier 4, V. Massard 5, A. Giraudet 6, A. Flechon 6, S. Girault 7, S. Abadie Lacourtoisie 7, C. Bailly 8
(1) Department of Medical Oncology, Institut Bergonié, Bordeaux, France – France, (2) ICANS, Strasbourg, France – France, (3) Institut de Cancérologie Strasbourg Europe, Strasbourg, France – France, (4) CHRU Nancy, Hopital Brabois, Vandœuvre-Lès-Nancy, France – France, (5) Institut de Cancérologie de Lorraine, Vandœuvre-Lès-Nancy, France – France, (6) Centre Léon Bérard, Lyon, France – France, (7) ICO Paul Papin, Angers, France – France, (8) CHU de Nantes, Hotel Dieu – HME, Nantes, France – France
Objective:
VISION study demonstrated that adding [177Lu]Lu-PSMA-617 to BSoC improved imaging-based progression-free survival and overall survival in patients with PSMA-positive mCRPC. French Health Authorities approved an early access “cohort” for [177Lu]Lu-PSMA-617 in this setting.
Methods:
PSMA positive mCRPC patients who had received at least 1 taxane-based chemotherapy and ≥1 ARPI were included. [177Lu]Lu-PSMA-617 (7.4 GBq) was given up to 6 cycles every 6 weeks. Patients’ characteristics and safety data are reported for the whole population. Efficacy was assessed within a sub-population with a minimum of 6 months follow-up after 1st [177Lu]Lu-PSMA-617 injection. AE grading was not performed.
Results:
From 1/12/2021 to 31/10/2023, 1340 patients were included, and 696 patients were evaluated for efficacy. At data cut-off, 749 were still on treatment, 591 discontinued treatments including 259 due to disease progression (43.8%), AE (9.8%) or death (6.0%). 210 patients (35.5%) finished all 6 injections.
Patients baseline characteristics: median age 73.4 years; ECOG 0-1: 87.4%; median PSA level 63 ng/ml; metastatic sites: bone 93.4%, lymph node 60.9%, liver 9.3%; prior taxane regimen: 97.4% of which 56.6% had 2; previous ARPI treatment: 100% and 64.3% had 2 or more (median: 2). Concomitant treatment with ARPI was observed in 26.3%.
Regarding efficacy results, the median progression free survival at imaging was determined by investigators (Conventional or TEP imaging) with a median of 7.3 months. The median time to clinical symptoms progression was 7.7 months. 68.4% of patients had a reduction in PSA level at any time point.
Patients received a median of 4 cycles.
12.0 % (n= 159) of patients experienced >1 treatment-related AE(TRAE). Most AE were considered as anticipated (244/344). The most common class of reported TRAE was hematotoxicity (192/344 TRAE).
Conclusions:
In this real life cohort of mCRPC treated with [177Lu]Lu-PSMA-617 patients were heavily pretreated, received less concomitant ARPI treatment and higher incidence of 2 prior taxane regimens compared to VISION. Patient profile is evolving with patients in earlier lines after several months of experience. Safety profile of [177Lu]Lu-PSMA-617 remains favorable. The cohort is still ongoing, updated results will be presented at urology summit, including longer follow-up period and higher number of patients who completed treatment.