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177Lu-PSMA-617 or a Change of ARPI for Taxane-Naive Metastatic Castration-Resistant Prostate Cancer?
177Lu-PSMA-617 is a prostate-specific membrane antigen (PSMA)–targeted radioligand therapy that is FDA approved for PSMA-positive, metastatic castration-resistant prostate cancer (mCRPC) with disease progression following treatment with an androgen-receptor pathway inhibitor (ARPI) and docetaxel. In the industry-sponsored, multinational, phase 3 PSMAfore trial, 468 patients with progressive docetaxel-naive mCRPC were randomized to switch to an alternative ARPI (abiraterone or enzalutamide) or to receive 177Lu-PSMA-617 once every 6 weeks for 6 cycles.
Among the key findings:
- Radiographic progression-free survival, the primary outcome, was significantly improved in the 177Lu-PSMA-617 arm compared with the alternative-ARPI arm (median, 11.6 vs. 5.6 months).
- Grade 3–5 adverse events were less frequent with 177Lu-PSMA-617 than with the alternative ARPI (36% vs. 48%).
- Overall survival did not differ between groups.
Comment
As noted by editorialists, given the absence of clear criteria for identifying patients who would more likely benefit from treatment with the alternative ARPI in lieu of docetaxel, the generalizability of these findings is limited. As this study did not allow docetaxel as a potential comparator, we remain without level 1 evidence to make decisions regarding the optimal agent to use in this clinical setting. If the FDA label for 177Lu-PSMA-617 is broadened, I will consider its use in selected patients with PSMA-positive mCRPC, especially those without significant disease-related symptoms.
Citation(s)
Author:
Morris MJ et al.
Title:
177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomised, controlled trial.
Source:
Lancet
2024
Sep
15; [e-pub].
(Abstract/FREE Full Text)
Author:
Mateo J and Zurita AJ.
Title:
177Lu-PSMA-617 for metastatic prostate cancer: Aiming for the right spot.
Source:
Lancet
2024
Sep
13; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Robert Dreicer, MD, MS, MACP, FASCO