VISION trial shows improved survival with 177Lu-PSMA-617 in mCRPC

Addition of ¹⁷⁷Lu-PSMA-617 radioligand therapy to standard of care for patients with metastatic castration-resistant prostate cancer (mCRPC) significantly improved survival, according to results from the randomised, phase 3 VISION trial.

Despite recent therapeutic advances, mCRPC remains invariably fatal. Prostate-specific membrane antigen (PSMA) is highly expressed in mCRPC lesions. The targeted radioligand ¹⁷⁷Lu-PSMA-617 delivers β-particle radiation to PSMA-expressing cells and the surrounding microenvironment [1].

The VISION trial (NCT03511664) is an international, randomised, open-label, phase 3 study evaluating ¹⁷⁷Lu-PSMA-617 in men with PSMA-positive mCRPC, previously treated with next-generation androgen receptor signalling inhibition and 1–2 taxane regimens. The trial randomised 831 patients 2:1 to ¹⁷⁷Lu-PSMA-617 (7.4 GBq every 6 weeks x 6 cycles) plus standard of care or standard of care alone (investigator determined but excluding cytotoxic chemotherapy and radium-223). The alternate primary endpoints were radiographic progression-free survival and overall survival. Key secondary endpoints were objective response rate, disease control rate, and time to first symptomatic skeletal event. Dr Michael Morris (Memorial Sloan Kettering Cancer Center, NY, USA) presented the results of the VISION trial after a median follow-up of 20.9 months [2].

The addition of ¹⁷⁷Lu-PSMA-617 therapy to standard of care significantly improved median radiographic progression-free survival versus standard of care alone (8.7 months vs 3.4 months). The alternate primary endpoint of overall survival was also significantly improved versus standard of care (median 15.3 vs 11.3 months, respectively). All key secondary endpoints were statistically significant between the treatment arms in favour of ¹⁷⁷Lu-PSMA-617 plus standard of care, including overall response rate (51.0% vs 3.1%) and disease control rate (86.3% vs 50.0%).

While a higher rate of high-grade treatment-emergent adverse events was observed with ¹⁷⁷Lu-PSMA-617 (any grade: 85.3% vs 28.8%; grade 3-5: 28.4% vs 3.9%), therapy was generally well tolerated.

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   1. Kratochwil C, et al. J Nucl Med. 2016 Aug;57(8):1170-6.
   2. Morris MJ, et al. Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). Abstract LBA4, ASCO 2021 Virtual Meeting, 4–8 June.

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Posted on 12 August 202115 October 2024