Nuklearmedizin 2025; 64(01): 45-46
DOI: 10.1055/s-0045-1804283
Abstracts │ NuklearMedizin 2025
Leuchtturm-Vorträge
Beste Abstracts

Symptomatic skeletal events, health-related quality of life and pain in a phase III study of [177Lu]Lu-PSMA-617 in taxane-naive patients with PSMA-positive metastatic castration-resistant prostate cancer: Third interim analysis of PSMAfore

K Fizazi
1   Cancer Medicine Department, Institut Gustave Roussy, Villejuif, Frankreich
,
M Morris
2   Medicine Department, MSKCC – Memorial Sloan Kettering Cancer Center, New York, USA
,
N Shore
3   Department of Urology, Carolina Urologic Research Center, Myrtle Beach, USA
,
K Chi
4   Medial Oncology Department, BC Cancer Agency, Vancouver, Kanada
,
M Crosby
5   Veterans Prostate Cancer Awareness Inc., Washington DC, USA
,
J De Bono
6   The Institute of Cancer Research and The Royal Marsden Hospital, London, United Kingdom
,
K Herrmann
7   Department of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Deutschland
,
G Roubaud
8   Medical Oncology Department, Institut Bergonié, Bordeaux, Frankreich
,
J Nagarajah
9   Department of Medical Imaging, Radboud University Medical Centre, Nijmegen, Niederlande
,
M Fleming
10   GU, Virginia Oncology Associates, Norfolk, USA
,
B Lewis
11   Tulane Cancer Center, Tulane University School of Medicine, New Orleans, USA
,
L T Nordquist
12   Medical Oncology, XCancer, Urology Cancer Center and GU Research Network, Omaha, USA
,
D E Castellano Gauna
13   Medial Oncology Department, Hospital Univeritario 12 de Octubre, Madrid, Spanien
,
N Carnahan
14   Development, Novartis Pharmaceuticals, Morrisville, USA
,
S Ghebremariam
15   Oncology, Novartis Pharmaceuticals Corporation, East Hanover, USA
,
M Hertelendi
16   Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, USA
,
M Eiber
17   Department of Nuclear Medicine, Klinikum Rechts Der Isar, Technical University of Munich and Bavarian Cancer Research Center (BZKF), München, Deutschland
,
O A Sartor
18   Department of Hematology/Oncology, Mayo Clinic – Rochester, Rochester, USA
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    Ziel/Aim: In PSMAfore (NCT04689828), [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged rPFS versus androgen receptor pathway inhibitor (ARPI) change in taxane-naive patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). We now present the time to symptomatic skeletal events (SSE) and time to worsening (TTW) in health-related quality of life (HRQoL) and pain at the third interim analysis (data cutoff, 27 Feb 2024).

    Methodik/Methods: Eligible patients had mCRPC, were candidates for ARPI change after one progression on previous ARPI, and had≥1 PSMA-positive and no exclusionary PSMA-negative metastatic lesions by [68Ga]Ga-PSMA-11 PET/CT. Patients were randomized 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq q6w; 6 cycles) or ARPI change (abiraterone/enzalutamide). Patients with confirmed radiographic progression on ARPI change could cross over to 177Lu-PSMA-617. The primary endpoint was rPFS. Other endpoints included time to SSE and TTW in self-reported HRQoL (FACT-P, EQ-5D-5L; secondary) and pain (BPI-SF; exploratory).

    Ergebnisse/Results: In total, 468 patients (234/arm) were randomized. Median duration of exposure was 8.4 months for 177Lu-PSMA-617 and 6.5 months for ARPI change. 177Lu-PSMA-617 prolonged time to SSE (27 [11.5%] vs 63 [26.9%]) and fewer bone fractures were reported versus ARPI change (4 [1.7%] vs 13 [5.6%]). 177Lu-PSMA-617 prolonged TTW in FACT-P (7,46 [6.08, 8.54]vs 4.27 [3.45, 4.50]), EQ-5D-5L (6,28 [4.70, 7.86] vs 3.88 [3.25, 4.44]) and BPI-SF (5.13 [4.11, 6.14] vs 3.65 [3.05, 4.34]) versus ARPI change. Incidences of grade≥3 adverse events (AEs), serious AEs and AEs leading to discontinuation for 177Lu-PSMA-617 and ARPI change were 36% and 48%, 20% and 32%, and 5.7% and 5.2%, respectively.

    Schlussfolgerungen/Conclusion: 177Lu-PSMA-617 clinically meaningfully and significantly prolonged time to SSE and TTW in self-reported HRQoL and pain versus ARPI change in taxane-naive patients with PSMA-positive mCRPC.

    The presenter Prof. Matthias Eiber was not part of the original analysis (Original Abstract was presented at ESMO 2024 1599P).


     

    Publication History

    Article published online:
    12 March 2025

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