Primary end point

Radiographic Progression-Free Survival

PSMAfore: A study of PLUVICTO after only 1 ARPI

In the primary analysis, PLUVICTO achieved statistically significant rPFS¹

• Median rPFS was 9.3 months with PLUVICTO vs 5.6 months with a change in ARPI (HR=0.41 [95% CI, 0.29-0.56]; P<0.0001)

In the updated exploratory analysis

PLUVICTO MORE THAN DOUBLED MEDIAN rPFS vs A CHANGE IN ARPI²

UPDATED MEDIAN rPFS

• Exploratory rPFS analysis was performed with a median follow-up period of 24 months vs the primary analysis at 7 months. This analysis was not controlled for Type-I error²

Key secondary end point

OS: Numerically favored PLUVICTO but was not statistically significant; high crossover rate may have confounded OS analysis¹

• At the preplanned final analysis,* HR=0.91 (95% CI, 0.72-1.14); median OS was 24.5 months with PLUVICTO and 23.1 months with a change in ARPI¹

• 60.3% of patients randomized to the change in ARPI arm subsequently crossed over to receive PLUVICTO following confirmed radiographic progression³

ARPI, androgen receptor pathway inhibitor; HR, hazard ratio; OS, overall survival; rPFS, radiographic progression-free survival.
*Data cutoff for the final analysis was January 1, 2025, with a total of 299 events occurring.³

Additional End Points

Half of patients treated with PLUVICTO achieved a response¹

ORR: MORE PATIENTS HAD A RESPONSE TO PLUVICTO, WITH >7x MORE COMPLETE RESPONSES SEEN WITH PLUVICTO vs A CHANGE IN ARPI^1,*

ORR^a MEASURED BY RECIST 1.1^b

ORR=CR+PR. 
^aResponses are based on soft tissue and bone lesion assessment.
^bPatients with measurable disease at baseline.

PSA: MORE PATIENTS HAD A PSA DECLINE WITH PLUVICTO vs A CHANGE IN ARPI^2,*

• Data are from patients with available PSA measurements at the time of the third data cutoff

• PSA50 response was defined as a confirmed decrease of 50% or greater

CR, complete response; ORR, overall response rate; PR, partial response; PSA, prostate-specific antigen; RECIST, Response Evaluation Criteria in Solid Tumors.
*Not powered for statistical significance.

Quality of Life

Patient-reported outcomes for PLUVICTO

PSMAfore: PLUVICTO TIME TO WORSENING OF HRQOL vs A CHANGE IN ARPI

• The FACT-P total score is the sum of the scores of 39 items of the questionnaire and ranges from 1 to 156, with higher scores indicating better quality of life. FACT-P measures physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscale⁴

• BPI-SF assessed the severity of patients’ pain and its impact on daily function through a 13-question form, with scores ranging from 0 to 10 and lower scores representing lower levels of pain intensity. BPI-SF measures pain intensity (worst, least, average, current), pain relief, and interference of pain⁴

• Both time to worsening FACT-P total score and time to worsening BPI-SF pain intensity were preplanned secondary end points²

• Type-I error was not controlled in the quality of life analyses. There was no hypothesis testing for patient-reported outcomes and no control was applied. These results are not statistically significant and should be interpreted with caution⁴

BPI-SF, Brief Pain Inventory–Short Form; FACT-P, Functional Assessment of Cancer Therapy–Prostate; HRQOL, health-related quality of life.

PSMAfore Trial Design

PSMAfore was a phase 3 trial comparing PLUVICTO vs a change in ARPI for chemo-naive patients²

THIS RANDOMIZED, MULTICENTER, OPEN-LABEL, ACTIVE-CONTROLLED STUDY COMPARED PLUVICTO vs A CHANGE IN ARPI^1,2

Primary end point: rPFS¹
Key secondary end point: OS² 
Select additional end points: ORR, PSA response, HRQOL⁵

Patients were considered appropriate for delay of taxane-based chemotherapy by the investigator.¹

Upon centrally reviewed radiographic progression:

• Patients randomized to receive a change in ARPI were permitted to cross over to the PLUVICTO arm¹

• Patients in the PLUVICTO arm were permitted to receive subsequent therapies outside of the trial²

  -  47% of patients received subsequent chemotherapy

*Patients were not excluded if they received [neo]adjuvant taxane more than 12 months ago.¹

Patient characteristics in the PSMAfore trial were well balanced²

PSMAfore ENROLLED 468 MEN WITH PSMA+ mCRPC WHO HAD PROGRESSED ON 1 PRIOR ARPI^1,2

ECOG, Eastern Cooperative Oncology Group; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; PSMA+, PSMA positive.