The PSMAfore Trial Showed That Longer Life Without Progression Is Possible With PLUVICTO.1 That's a Victory.
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 analysis1,2
60.3% of patients randomized to the change in ARPI arm subsequently crossed over to receive PLUVICTO following confirmed radiographic progression3
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
With an IPCW method analysis,† HR=0.59 (95% CI, 0.38-0.91)3
ARPI, androgen receptor pathway inhibitor; HR, hazard ratio; IPCW, inverse probability of censoring weighting; 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
†IPCW method is a multivariate model that uses time-varying weights estimated for non-crossover control arm patients to reflect how similar they are to crossover patients using propensity methods. Arms are then compared using the weighted Cox model.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 ARPI1,*
ORRa MEASURED BY RECIST 1.1b
ORR=CR+PR.
CR, complete response; ORR, overall response rate; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.
*Not powered by statistical significance.
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 ARPI2,*
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
PSA, prostate-specific antigen.
*Not powered for statistical significance.
Patient-Reported Outcomes
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.
Treatment Guidelines
LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (PLUVICTO) IS A NATIONAL COMPREHENSIVE CANCER NETWORK® (NCCN®) RECOMMENDED OPTION FOR PATIENTS WITH mCRPC5
NCCN Category 2A* recommended, useful in certain circumstances, for mCRPC patients with:
At least 1 PSMA-positive (PSMA+) lesion and/or metastatic disease that is predominantly PSMA+
No dominant PSMA-negative metastatic lesions
Progression on prior androgen receptor-directed therapy and no prior taxane-based chemotherapy
mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; PSMA+, PSMA positive.
*A Category 2A rating is based upon lower-level evidence; there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
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.
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 ARPI1,2
Primary end point: rPFS1
Key secondary end point: OS2
Select additional end points: ORR, PSA response, HRQOL6
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, 19% received radiotherapy, 13% received hormonal therapy, and <5% received other anticancer therapies
*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 ARPI1,2
PSMAfore trial included patients with PSMA+ mCRPC, regardless of number of metastatic sites, location, or symptomatology1,2,*
ECOG, Eastern Cooperative Oncology Group.
*Metastatic sites excluded PSMA-negative lesions exceeding specified minimum dimensions; location included lung, liver, lymph node, and bone.
Which of your patients with PSMA+ mCRPC could benefit from PLUVICTO now?