(UroToday.com) The 2025 ESMO annual meeting featured a prostate cancer session and a presentation by Dr. Vincent Massard discussing the final analysis of patients treated with 177Lu-PSMA-617 in an early access program in metastatic castration-resistant prostate cancer (mCRPC) in France. 177Lu-PSMA-617 is a radiopharmaceutical with binding affinity to PSMA, expressed in 90% of mCRPC patients. The VISION trial showed that 177Lu-PSMA-617 added to best standard of care prolonged imaging-based progression-free and overall survival in patients with PSMA-positive mCRPC.1 Subsequently, the French Health Authorities granted early access for 177Lu-PSMA-617 in this indication since December 2021 (which ended on April 29, 2025). This study assessed descriptive analyses comparing the characteristics, safety, and efficacy of 177Lu-PSMA-617 in patients treated in France as part of the Early Access Program, with comparisons stratified by year of patient inclusion in the program.
PSMA-positive mCRPC patients pretreated with ≥1 taxane chemotherapy regimen and ≥1 androgen receptor pathway inhibitor were included. 177Lu-PSMA-617 (7.4 GBq) was given up to 6 cycles every 6 weeks. Patient characteristics and safety data were described for 3,709 patients (data cut-off 1: April 29, 2025). Efficacy was analyzed in 2,476 patients (data cut-off 2: August 29, 2024):
Patient characteristics of the 3,709 patients with mCRPC treated in the Early Access Program are listed in the following table:
Over time, patients included in the Early Access Program were older and tended to have lower PSA levels, as well as fewer of them having 100% PSMA-positive lesions and metastases at inclusion. Previous treatments received stratified by year is as follows, noting that patients were progressively less heavily pre-treated with chemotherapy and androgen receptor pathway inhibitors:
Concomitant treatment with androgen receptor pathway inhibitor was observed in 24.4% of patients:
Imaging follow-up was performed according to investigator’s choice, with an unknown distribution between conventional imaging, PSMA PET, and SPECT-CT. At the second data cut-off, the median imaging-based progression free survival was 7.6 months, and the median time to clinical progression was 8.1 months:
Patients pretreated with two taxane chemotherapies or not receiving concomitant androgen receptor pathway inhibitors appeared to progress quicker than those who received one chemotherapy or concomitant androgen receptor pathway inhibitor:
The most common cause of early treatment discontinuation was progressive disease (46.2%):
Treatment related adverse events occurred in 12.5% (n = 465), including a total of 908 adverse events reported. The most common reported treatment related adverse events were thrombocytopenia and anemia.
Dr. Massard concluded his presentation discussing the final analysis of patients treated with 177Lu-PSMA-617 in an early access program in mCRPC in France with the following take home points:
- An Early Access Program has been granted to 177Lu-PSMA-617 in France, for patients with progressive mCRPC expressing PSMA, previously treated with ≥1 taxane chemotherapy and ≥1 androgen receptor pathway inhibitor
- From December 01, 2021 to April 29, 2025, 3,709 PSMA-PET-positive mCRPC patients were included in this Early Access Program
- Over time, patient profile remained quite stable:
- Even though patients were older and presenting with lower PSA levels
- Patients were also less heavily pretreated (androgen receptor pathway inhibitor, taxane chemotherapy)
- Patients who received two taxane-based chemotherapy appear to progress more rapidly than those who received one
- Patients receiving concomitant androgen receptor pathway inhibitor seem to progress more slowly than those who did not
- No new safety signals have been identified, with most safety signals as expected
Presented by: Vincent Massard, Institut de Cancerologie de Lorraine, Vandoeuvre-lès-Nancy, France
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 European Society for Medical Oncology (ESMO) Annual Congress, Berlin, Germany, October 17–21, 2025
References:
- Sartor O, de Bono J, Chi KN et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103.