The Safety Profile for PLUVICTO Was Established in the VISION Trial¹

Adverse Events

VISION: A study of PLUVICTO after ARPI & chemo

ADVERSE REACTIONS OCCURRING AT ≥10% INCIDENCE IN PATIENTS WHO RECEIVED PLUVICTO + BSOC^1,a

^aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.^2
bIncludes multiple similar terms.¹

• 12% of patients discontinued PLUVICTO + BSOC due to any TEAEs vs 8% with BSOC alone³

• 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; BSOC, best standard of care; TEAE, treatment-emergent adverse event.
 

Laboratory Abnormalities

SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE IN PATIENTS WITH PSMA-POSITIVE mCRPC WHO RECEIVED PLUVICTO + BSOC (BETWEEN-ARM DIFFERENCE OF ≥5% ALL GRADES) IN VISION¹

mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen.
^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.

No unexpected laboratory abnormalities were reported in the VISION trial^1,2