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.^4
b Patients with measurable disease at baseline.^4
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.

Treatment Guidelines

NATIONAL COMPREHENSIVE CANCER NETWORK^® (NCCN^®) CATEGORY 1* RECOMMENDATION⁶

Lutetium Lu 177 vipivotide tetraxetan (PLUVICTO) is a Category 1 Recommended option that is useful in certain circumstances for patients with metastatic castration-resistant prostate cancer who have:

• At least 1 PSMA-positive (PSMA+) lesion and/or metastatic disease that is predominantly PSMA+

• No dominant PSMA-negative metastatic lesions^† 

• Previously received androgen receptor-directed therapy and taxane-based chemotherapy

This recommendation is based on the published phase 3 VISION data, which evaluated lutetium Lu 177 vipivotide tetraxetan (PLUVICTO) and standard of care^‡ overall survival and progression-free survival benefit vs standard of care alone.

PSMA+, prostrate-specific membrane antigen positive.
*A Category 1 rating is based upon high-level evidence; there is uniform NCCN consensus that the intervention is appropriate.
^†PSMA-negative lesions are defined by NCCN as metastatic disease that lacks PSMA uptake, including bone with soft tissue components ≥1.0 cm, lymph nodes ≥2.5 cm in short axis, and solid organ metastases ≥1.0 cm in size. 
^‡Abiraterone, enzalutamide, bisphosphonates, radiation therapy, denosumab, and/or glucocorticoids. 
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

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

Alternate primary end points*: rPFS, OS
Select secondary end points: ORR, PSA decline

PLUVICTO WAS STUDIED IN COMBINATION WITH BSOC

• 52.6% of patients in the PLUVICTO + BSOC arm received concomitant treatment with an ARPI⁴

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