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A promising cancer drug hits a wall in kidney cancer. The phase 2 LASER trial testing lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in PSMA-positive clear cell renal cell carcinoma (ccRCC) closed early after zero responses among the first 9 patients. While the drug is FDA-approved for prostate cancer, it didn't translate to kidney cancer — though researchers say the broader radiopharmaceutical story isn't over.
A promising cancer drug hits a wall in kidney cancer
The phase 2 LASER trial testing lutetium Lu 177 vipivotide tetraxetan (Pluvicto) — an FDA-approved radioligand therapy for PSMA-positive prostate cancer — in patients with PSMA-positive metastatic clear cell renal cell carcinoma (ccRCC) has closed early for futility. None of the first 9 heavily pretreated patients (median 4 prior lines of therapy) achieved an objective response, triggering the trial's pre-specified futility rule and halting enrollment before its second stage.
The trial also revealed a key biological finding: PSMA expression in ccRCC is far more heterogeneous than in prostate cancer, with a significant proportion of patients showing PSMA-negative lesions on screening PET. This prompted mid-trial eligibility adjustments, allowing up to 25% PSMA-negative disease — boosting screening eligibility from ~50% to ~90%.
By the Numbers
Why it matters: While this chapter on PSMA-directed therapy in kidney cancer appears closed, the trial generated valuable real-world PET data on PSMA heterogeneity in ccRCC — insights that could guide development of next-generation radiopharmaceuticals targeting tumor-specific markers like CA9.
