BSOC, best standard of care; mCRPC, metastatic castration-resistant prostate cancer; OS, overall survival; RLT, radioligand therapy.
Post hoc exploratory subgroup analysis4,5
PLUVICTO + BSOC median OS (months) | BSOC alone median OS (months) | |
1 prior taxane | 16.2 (n/N=206/342) | 11.8 (n/N=108/165) |
2 prior taxanesa | 13.6 (n/N=112/170) | 10.6 (n/N=70/99) |
a Of the 831 patients, 8 had received more than 2 taxanes previously.2
Limitations: No formal statistical testing was planned for this exploratory subgroup analysis; therefore, there was no prespecified statistical procedure controlling for type 1 error. These results should be interpreted with caution.
Radiographic Progression-Free Survival
PATIENTS TREATED WITH PLUVICTO + BSOC HAD A STATISTICALLY SIGNIFICANT IMPROVEMENT IN rPFS: 8.7 MONTHS VS 3.4 MONTHS WITH BSOC ALONE4
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.
Overall Response Rate
PLUVICTO + BSOC SIGNIFICANTLY IMPROVED OVERALL RESPONSE RATES VS BSOC ALONE1,3
CR, complete response; ORR, overall response rate; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors. ORR=CR+PR.
a ORR is reported as a measure of response in soft tissue, lymph node, or visceral lesions.3
b Patients with evaluable disease from baseline.3
c Stratified Wald's Chi-square test 2-sided P value.1,3
PSA Decline
46% OF PATIENTS WHO RECEIVED PLUVICTO + BSOC HAD A PSA DECLINE ≥50% VS 7% OF PATIENTS WHO RECEIVED BSOC ALONE3
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 later.
PET, positron emission tomography; PSA, prostate-specific antigen.
a Odds ratio 11.19 (95% CI, 6.25-20.04).
b Odds ratio 23.62 (95% CI, 8.57-65.11).
Data are from patients with available PSA data allocated to PLUVICTO + BSOC or BSOC alone
The proportion of patients with any decrease in best percentage change from baseline was 71.5% with PLUVICTO + BSOC, 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; eg, no alpha control was applied. Increases greater than 100% are truncated to 100%
VISION Trial Design
TRIAL DESIGN
PLUVICTO was studied in VISION, the largest international phase 3 trial of a targeted RLT
The VISION trial was a randomized, multicenter, active-control study comparing PLUVICTO + BSOC vs BSOC alone1,2
This prospective, open-label study enrolled 831 men with PSMA+ mCRPC who had disease progression on at least 1 ARPI and 1 or 2 taxane regimens
VISION was an active-controlled study: Participants were randomized to receive PLUVICTO + BSOC (physician's choice as defined below) or BSOC (physician's choice) alone
Pivotal VISION Phase 3 trial design
ARPI, androgen receptor pathway inhibitor; ECOG, Eastern Cooperative Oncology Group; ECOG PS, ECOG performance status; LHRH, luteinizing hormone-releasing hormone; PSMA+, prostate-specific membrane antigen positive.
a 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.
Stratification factors1,3
Inclusion of ARPI at time of randomization (yes vs no)
Baseline lactate dehydrogenase (LDH) (≤260 IU/L vs >260 IU/L)
Presence of liver metastases (yes vs no)
ECOG PS (0-1 vs 2)
PATIENT CHARACTERISTICS1,2
The phase 3 VISION trial enrolled men with PSMA+ mCRPC who had progressed on ARPI and taxane therapy
Baseline patient characteristics were well balanced across the treatment and control arms*
PFS, progression-free survival.
*The analysis set for imaging-based PFS included patients who underwent randomization on or after March 5, 2019, the date on which trial-site education measures were implemented to reduce the incidence of withdrawal in the control group. Percentages may not total 100 because of rounding.
a ECOG PS scores range from 0 to 5, with higher numbers indicating greater disability.
b Data were missing for a very small number of patients.
c Scores on the Gleason scale range from 2 to 10, with higher scores indicating a worse prognosis. A score of 8 to 10 indicates high-grade cancer. In the remaining patients whose score was known, the Gleason score was 2 to 7 (intermediate- or low-grade cancer).
d ARPIs were defined as enzalutamide, abiraterone, and apalutamide.
e Taxanes were defined as cabazitaxel, docetaxel, and paclitaxel. Of the 831 patients, 8 (1.0%) had received more than 2 taxanes previously. Overall, the reasons for the last taxane therapy were therapeutic use in 559 of 831 patients (67.3%), adjuvant therapy in 109 (13.1%), unknown in 106 (12.8%), neoadjuvant therapy in 33 (4.0%), maintenance therapy in 17 (2.0%), other in 5 (0.6%), and prophylaxis in 2 (0.2%). The use of taxanes was well balanced between treatment groups in both analysis sets.
Could your patient with mCRPC benefit from PLUVICTO?