Pluvicto (lutetium 177 vipivotide tetraxetan), a radiopharmaceutical that delivers radiation directly to cancer cells, reduced the risk of disease progression for men with metastatic prostate cancer who had not yet received chemotherapy.

Pluvicto is currently approved for patients with PSMA-positive metastatic castration-resistant prostate cancer that has progressed despite androgen-blocking therapy and chemotherapy. The Phase III PSMAfore trial tested the therapy in a broader population of men with earlier-stage metastatic cancer who had not yet received chemotherapy but had used an oral androgen receptor pathway inhibitor, such as Xtandi (enzalutamide) or Zytiga (abiraterone). They were randomly assigned to receive Pluvicto or switch to an androgen blocker they hadn’t yet tried.

Pluvicto reduced the risk of radiographic disease progression or death by 59% compared with a new androgen blocker, doubling progression-free survival time from a median of 5.6 to 12.0 months. What’s more, people who received Pluvicto reported improved quality of life, including less pain. However, study participants who experienced disease progression were allowed to cross over from an androgen blocker to Pluvicto—and more than 80% did so—making it difficult to compare overall survival.

Novartis plans to request expanded approval of Pluvicto next year for men with metastatic prostate cancer who have not received chemotherapy. “We look forward to a future where Pluvicto may be a viable therapy for patients in need of alternative, earlier options,” says study investigator Oliver Sartor, MD, of the Mayo Clinic.