The Safety Profile for PLUVICTO Was Established in the VISION Trial1
In the VISION trial, PLUVICTO + best standard of care (BSOC) demonstrated a proven safety profile in patients with PSMA-positive mCRPC after ARPI and chemotherapy, with 12% of patients discontinuing treatment due to treatment-emergent adverse events vs 8% with BSOC alone.1,2
Adverse Reactions
VISION: A study of PLUVICTO after ARPI & chemo
ADVERSE REACTIONS OCCURRING AT ≥10% INCIDENCE IN PATIENTS WHO RECEIVED PLUVICTO + BSOC1,a
| PLUVICTO + BSOC (n=529) | BSOC (n=205) | |||
Adverse reactions | All grades | Grades 3 or 4 | All grades | Grades 3 or 4 | |
General disorders | 48 | 7 | 29 | 2.4 | |
| Fatigueb | ||||
| Decreased appetite | 21 | 1.9 | 15 | 0.5 |
| Weight decreased | 11 | 0.4 | 10 | 0.5 |
| Peripheral edemab | 10 | 0.4 | 7 | 1 |
Gastrointestinal disorders | 39 | 0 | 1 | 0 | |
| Dry mouthb | ||||
| Nausea | 36 | 1.3 | 17 | 0.5 |
| Constipation | 20 | 1.1 | 11 | 0.5 |
| Vomitingb | 19 | 0.9 | 6 | 0.5 |
| Diarrhea | 19 | 0.8 | 2.9 | 0.5 |
| Abdominal painb | 12 | 1.3 | 6 | 0.5 |
Musculoskeletal and | 24 | 3.6 | 15 | 3.9 | |
| Back pain | ||||
| Arthralgia | 22 | 1.1 | 13 | 0.5 |
| Bone pain | 11 | 2.5 | 8 | 2.4 |
Renal and urinary disorders | 12 | 3.8 | 1 | 0.5 | |
| Urinary tract infectionb | ||||
aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.3
bIncludes multiple similar terms.1
12% of patients discontinued PLUVICTO + BSOC due to any TEAEs vs 8% with BSOC alone2
Clinically relevant ARs in <10% of patients who received PLUVICTO + BSOC included acute kidney injury, dizziness, dysgeusia, headache, pyrexia, dry eye, oral fungal infection, vertigo, gastroesophageal reflux disease, stomatitis, pancytopenia, dry skin, dysphagia, esophagitis, and bone marrow failure1
ARPI, androgen receptor pathway inhibitor; AR, adverse reaction; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; TEAE, treatment-emergent adverse event.
Laboratory Abnormalities
SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE IN PATIENTS WITH PSMA-POSITIVE mAPMR PC (mCRPC) WHO RECEIVED PLUVICTO + BSOC OR BSOC (BETWEEN-ARM DIFFERENCE OF ≥5% ALL GRADES) IN VISION1
| PLUVICTO + BSOCa | BSOCb | |||
Laboratory abnormalities | All grades | Grades 3 or 4 | All grades | Grades 3 or 4 | |
Hematology | 85 | 47 | 51 | 18 | |
| Decreased lymphocytes | ||||
| Decreased hemoglobin | 64 | 15c | 34 | 7c |
| Decreased platelets | 45 | 9 | 20 | 2.5 |
| Decreased neutrophils | 28 | 4.7 | 9 | 0.5 |
Chemistry | 42 | 3.4 | 31 | 2.5 | |
| Decreased eGFRd | ||||
| Decreased sodium | 34 | 0.6c | 23 | 1 |
| Decreased calcium | 34 | 1.9 | 18 | 1.5 |
| Increased aspartate | 29 | 1.1 | 18 | 1c |
| Increased potassium | 24 | 0.6 | 18 | 0.5c |
| Increased sodium | 11 | 0c | 5 | 0c |
eGFR, estimated glomerular filtration rate; mAPMR PC, metastatic androgen pathway modulation-resistant cancer.
aThe denominator used to calculate the rate for each laboratory parameter varied from 506 to 529 based on the number of patients with a baseline value and at least 1 posttreatment value.
bThe denominator used to calculate the rate for each laboratory parameter varied from 194 to 198 based on the number of patients with a baseline value and at least 1 posttreatment value.
cNo grade 4 laboratory abnormalities worsening from baseline were reported.
d“All grades” column represents patients having any worsened eGFR category of <90 mL/min/1.73 m2 and “grade 3 or 4” column represents patients having any worsened eGFR category of <30 mL/min/1.73 m2 calculated using the CKD-EPI formula.