Overall Survival

VISION: A study of PLUVICTO after ARPI & chemo

MEDIAN OS (ALTERNATE PRIMARY END POINT)^1,2

OVERALL SURVIVAL BY NUMBER OF PRIOR TAXANES³

PLUVICTO + BSOC and BSOC alone: Post hoc exploratory subgroup analysis from the VISION trial³

PATIENTS TREATED WITH 1 PRIOR TAXANE

PATIENTS TREATED WITH ≥2 PRIOR TAXANES

Limitations: No formal statistical testing was planned for this exploratory subgroup analysis; therefore, there was no prespecified statistical procedure controlling for Type-I error. These results should be interpreted with caution.

ARPI, androgen receptor pathway inhibitor; BSOC, best standard of care; HR, hazard ratio; OS, overall survival.

Radiographic Progression-Free Survival

SIGNIFICANT PROGRESSION-FREE SURVIVAL FOR YOUR PATIENTS ON PLUVICTO^2,3

rPFS was significantly longer with PLUVICTO + BSOC vs BSOC alone^2,3

MEDIAN rPFS (ALTERNATE PRIMARY END POINT)

Interpretation of the magnitude of the rPFS effect was limited due to a high degree of censoring from early dropout in the control arm.

rPFS, radiographic progression-free survival.

Additional End Points

ORR: HIGHER ORR AND MORE COMPLETE RESPONSES ACHIEVED WITH PLUVICTO^1,4

49% ORR achieved with PLUVICTO + BSOC^1,4

• CR was 9% with PLUVICTO + BSOC vs 0% with BSOC alone 
• PR was 40% with PLUVICTO + BSOC vs 1.6% with BSOC alone

ORR=CR+PR.
^a Responses are based on soft tissue assessment and bone lesion progression.^1
b Patients with measurable disease at baseline.^1
c Stratified Wald’s Chi-square test 2-sided P value.¹

MORE PATIENTS HAD A PSA DECLINE WITH PLUVICTO + BSOC vs BSOC ALONE^4,5 

^a Odds ratio: 11.19 (95% CI, 6.25-20.04).
 

• Data are from patients with available PSA data allocated to PLUVICTO + BSOC or BSOC alone

• Proportion of subjects who are PSA responders, defined as patients who achieved a ≥50% decrease from baseline that is confirmed by a second PSA measurement ≥4 weeks

• The proportion of patients with any decrease in best percentage change from baseline was 71.5% with PLUVICTO + BSOC and 35.5% with BSOC alone

• Data are from patients randomized after implementation of enhanced study-site education measures, N=581. PSA decline was assessed at the nominal 5% level; ie, no alpha control was applied

PATIENT-REPORTED OUTCOMES FOR PLUVICTO WERE ASSESSED BY FACT-P AND BPI-SF⁴

• 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 subscale^2,5

• BPI-SF assessed the severity of patients’ pain and its impact on daily function through a 9-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 pain (on 7 HRQOL dimensions of general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life)^2,5

• Both time to worsening FACT-P total score and time to worsening BPI-SF pain intensity were preplanned secondary end points. Data are from patients who were randomized after enhanced study site education measures who had a baseline assessment and at least 1 postbaseline assessment^2,4

• For analysis of each outcome, only patients with a baseline assessment and ≥1 postbaseline time point were included. Main models were adjusted for randomization stratification factors⁵

• Type-I error was not controlled in the quality of life analyses. There was no hypothesis testing for patient-reported outcomes and no α control was applied. These results are not statistically significant and should be interpreted with caution⁵

BPI-SF, Brief Pain Inventory–Short Form; CR, complete response; FACT-P, Functional Assessment of Cancer Therapy–Prostate; HRQOL, health-related quality of life; ORR, overall response rate; PR, partial response; PSA, prostate-specific antigen; RECIST, Response Evaluation Criteria in Solid Tumors.

VISION Trial Design

PLUVICTO was studied in the large, phase 3 VISION trial^1,2

THIS PROSPECTIVE, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY ENROLLED 831 MEN WITH PSMA+ mCRPC^1,2

Alternate primary end points*: rPFS, OS^1,2
Select secondary end points: ORR, PSA decline²

LHRH, luteinizing hormone-releasing hormone. 
*To be declared positive, the VISION study was required to reach statistical significance on the primary analysis of rPFS or OS, not both end points.^2
†In the phase 3 trial, combinations of any and all of these therapies were allowed and could be modified by the physician over time.^1,2