Dr Tagawa on the Efficacy of Lutetium Lu 177 Vipivotide Tetraxetan Plus ARPI and ADT in PSMA+ mHSPC

Scott T. Tagawa, MD, MS, FACP, FASCO, discusses the efficacy of lutetium Lu 177 vipivotide tetraxetan plus ARPI and ADT in mHSPC.

“This was an early readout; it was the first interim analysis for efficacy. At that time point, approximately 60% of patients in the control arm who had confirmed [disease] progression crossed over to receive lutetium Lu 177 vipivotide tetraxetan.”

Scott T. Tagawa, MD, MS, FACP, FASCO, a professor of medicine and urology at Weill Cornell Medicine and an attending physician at NewYork-Presbyterian – Weill Cornell Medical Center, discussed efficacy findings from the phase 3 PSMAddition trial (NCT04720157) which were presented during the 2025 ESMO Congress.

PSMAddition evaluated the addition of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT) for the treatment of patients with prostate specific-membrane antigen (PSMA)–positive metastatic hormone-sensitive prostate cancer (mHSPC).

Findings regarding the primary end point of radiographic progression-free survival (rPFS) revealed that patients who received lutetium Lu 177 vipivotide tetraxetan in combination with an ARPI and ADT (n = 572) achieved a significant rPFS benefit vs those treated with an ARPI plus ADT alone (n = 572; HR, 0.72; 95% CI, 0.58-0.90; P = .002).

Tagawa noted that the data presented during ESMO were from the first interim analysis and that 59.9% of patients in the control arm who experienced confirmed disease progression crossed over to the investigational arm. The level of crossover may affect some of the data regarding the secondary end points of the study, including overall survival (OS), he noted.

Although OS data are still not mature, a benefit in favor of the investigational arm (HR, 0.84; 95% CI, 0.63-1.13; P = .125) was observed despite the early crossover, he added. With OS data still evolving, a clear OS benefit may not be necessary to prove the advantage of the investigational arm over the control arm due to the high level of patient crossover, he explained.