This page/content is for Great Britain healthcare professionals only.
Pluvicto 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 or who are not medically suitable for taxanes.1
Locametz is for diagnostic use only. Locametz, after radiolabelling with gallium-68, is a radioactive diagnostic agent indicated for the identification of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adult patients with prostate cancer.2
Clinical Trials
VISION was an international, prospective, randomised, open-label, multicentre, Phase III study to assess the efficacy and safety of Pluvicto plus investigator-chosen best standard of care (BSoC) in the investigational arm, versus BSoC in the control arm. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomised in a 2:1 ratio in favour of the investigational arm. The alternate primary endpoints were radiographic progression free survival (rPFS) and overall survival (OS).3
The recommended Pluvicto dose is 7,400 MBq intravenously every 6 weeks (±1 week) for a total of 6 doses.1
View the study design for VISION below.
*Serum PSA progression was defined as 2 consecutive increases in PSA over a previous reference value measured at least 1-week prior, minimal start value is 2.0 ng/mL.4
†PSMA-positive disease sites were defined as ≥1 PSMA-positive lesions anywhere in the body, with PSMA PET imaging ligand uptake greater than that of liver parenchyma in one or more metastatic lesions in any organ system. No size criteria were applied on PSMA-positive lesions.3
‡The study protocol is not the same as the licensed posology. Please refer to the Pluvicto® Summary of Product Characteristics for full details on the licensed posology.1
§Imaging-based progression-free survival was defined as the time from randomisation to independently centrally reviewed disease progression (defined according to the Prostate Cancer Clinical Trials Working Group 3 criteria) or death.2
¶First SSE defined as first new symptomatic pathological bone fracture, spinal cord compression, tumour-related orthopaedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death from any cause, whichever occurred first.4
**Additional secondary endpoints included: safety and tolerability; HRQoL: EQ-5D-5L, FACT-P and BPI-SF; health economics; composite PFS (radiological, clinical or PSA progression); biochemical response: PSA, ALP and LDH levels.4
††Investigational products not approved for use in the UK.
Pluvicto + BSoC significantly extends survival in PSMA-positive mCRPC patients vs BSoC alone3
View the efficacy outcomes for VISION below.
Primary endpoints:
Secondary endpoints:
*ORR is reported as a measure of response in soft tissue, lymph node or visceral lesions.3
†Patients with evaluable disease from baseline.3
‡Data are from patients randomised after implementation of enhanced study site education, n=581.3
§OR: 11.19 (95 % CI: 6.25–20.04).3
¶OR: 23.62 (95 % CI: 8.57–65.11).3
The most common (≥20%) adverse drug reactions (ADRs) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include fatigue, dry mouth, nausea, anaemia, decreased appetite and constipation. The most common grade 3 to 4 ADRs (≥5%) occurring at a higher incidence in patients who received Pluvicto plus BSoC compared to BSoC alone include: anaemia (12.9%), thrombocytopenia (7.9%), lymphopenia (7.8%) and fatigue (5.9%).1
This list is not exhaustive; for further safety information please refer to the Great Britain Summary of Product Characteristics.1
ADR, adverse drug reaction; ALP, alkaline phosphatase; AR, androgen receptor; ARPI, androgen receptor pathway inhibitor; BM, bone marrow; BPI-SF, brief pain inventory (short form); BSoC, best standard of care; CI, confidence interval; CNS, central nervous system; CT, computed tomography; DCR, disease control rate; ECOG-PS, Easter Cooperative Oncology Group performance status; EQ-5D-5L, 5-level EuroQol-5 dimension version; FACT-P, functional assessment of cancer therapy-prostate; HR, hazard ratio; HRQoL, health-related quality of life; LDH, lactic acid dehydrogenase; LHRH, luteinising hormone releasing hormone; mCRPC, metastatic castration-resistant prostate cancer; MRI, magnetic resonance imaging; ORR, objective response rate; OS, overall survival; PCWG3, Prostate Cancer Clinical Trials Working Group 3; PET, positron emission tomography; PSA, prostrate-specific antigen; PSMA, prostate-specific membrane antigen; R, randomisation; RLT, radioligand therapy; rPFS, radiographic progression free survival; SSE, symptomatic skeletal event.
References:
- Pluvicto® Great Britain Summary of Product Characteristics.
- Locametz® Great Britain Summary of Product Characteristics.
- Sartor, O. et al. N Engl J Med 2021;385(12):1091–1103 and supplementary appendix.
- Sartor O, et al. N Engl J Med 2021;385(12):1091–1103. Study protocol.