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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.
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.
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
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).
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
Pivotal VISION phase 3 trial design
ARPI, androgen receptor pathway inhibitors; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; ECOG PS, ECOG performance status; LHRH, luteinizing hormone-releasing hormone; MRI, magnetic resonance imaging; PSMA, prostate-specific membrane antigen; PET, positron emission tomography; PSMA+, PSMA positive; RLT, radioligand therapy.
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
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.
References: 1. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc. 2. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. Published online June 23, 2021. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322. 3. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12)(suppl):1091-1103. doi:10.1056/NEJMoa2107322. 4. Data on file. VISION [PSMA-617-01] study. Novartis Pharmaceuticals Corp; 2021. 5. Viashampayan N, Morris MJ, Krause BJ, et al. [177Lu]Lu-PSMA-617 in PSMA-positive metastatic castration-resistant prostate cancer: prior and concomitant treatment subgroup analyses of the VISION trial. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 5, 2022; Chicago, IL. Abstract 5001.
Indication
PLUVICTO™ (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
IMPORTANT SAFETY INFORMATION
Risk From Radiation Exposure
PLUVICTO contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk for cancer.
Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with PLUVICTO consistent with institutional practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection.
Ensure patients increase oral fluid intake and advise them to void as often as possible to reduce bladder radiation.
To minimize radiation exposure to others, advise patients to limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days, to refrain from sexual activity for 7 days, and to sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days.
Myelosuppression
PLUVICTO can cause severe and life-threatening myelosuppression. In the VISION study, grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥3 pancytopenia occurred in 1.1% of patients (including 2 fatal events). Two deaths (0.4%) due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia were observed. One death due to sepsis and concurrent neutropenia was observed.
Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO and clinically treat patients based on severity of myelosuppression.
Renal Toxicity
PLUVICTO can cause severe renal toxicity. In the VISION study, grade 3 or 4 acute kidney injury (3%) and increased creatinine (0.9%) occurred in patients treated with PLUVICTO.
Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Perform kidney function laboratory tests, including serum creatinine and calculated creatinine clearance (CrCl), before and during treatment. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity of renal toxicity.
Embryo-Fetal Toxicity
The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm. No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radiopharmaceuticals, including PLUVICTO, have the potential to cause fetal harm. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose.
Infertility
The recommended cumulative dose of 44.4 GBq of PLUVICTO results in a radiation-absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility.
Adverse Reactions
The most common adverse reactions (≥20%) occurring at a higher incidence in patients who received PLUVICTO plus best standard of care (BSoC) were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. Clinically relevant adverse reactions in <5% of patients included dry eye, vertigo, and pancytopenia (including bicytopenia).
Laboratory Abnormalities
The most common laboratory abnormalities that worsened from baseline in ≥30% of patients who received PLUVICTO plus BSoC were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium.
Please see full Prescribing Information.
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