PLUVICTO Has a Favorable Safety Profile1,2
Adverse Events
PSMAfore: A study of PLUVICTO after only 1 ARPI
Grade ≥3 AE rates were lower in the PLUVICTO group with a longer median duration of exposure1
Incidence of grade ≥3 TEAEs: 36% with PLUVICTO (n=81) vs 48% with a change in ARPI (n=112)1
Median duration of exposure: 8.4 months with PLUVICTO vs 6.5 months with a change in ARPI1
PSMAfore: ADVERSE REACTIONS OCCURRING AT ≥10% INCIDENCE IN PATIENTS WHO RECEIVED PLUVICTO2,a
aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.3
bIncludes multiple similar terms.2
Clinically relevant ARs in <10% of patients who received PLUVICTO included dysgeusia, abdominal pain, peripheral edema, headache, acute kidney injury, weight decreased, urinary tract infection, dry eye, dizziness, dry skin, oral fungal infection, gastroesophageal reflux disease, pyrexia, vertigo, stomatitis, dysphagia, esophagitis, pancytopenia, and bone marrow failure2
PLUVICTO HAS PROVEN TOLERABILITY1,2
ARs leading to permanent discontinuation of PLUVICTO in ≥1% of patients who received PLUVICTO were thrombocytopenia (1.8%) and dry mouth (1.3%)2
The most frequent (≥0.5%) AR leading to a dose reduction of PLUVICTO in patients who received PLUVICTO was dry mouth (0.9%)2
The most frequent (≥1%) ARs leading to a dose interruption of PLUVICTO in patients who received PLUVICTO were COVID-19 (3.1%) and anemia (1.8%)2
AE, adverse event; AR, adverse reaction; ARPI, androgen receptor pathway inhibitor; TEAE, treatment-emergent adverse event.
Laboratory Abnormalities
SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE IN PATIENTS WITH PSMA-POSITIVE mCRPC WHO RECEIVED PLUVICTO OR CHANGE IN ARPI (BETWEEN-ARM DIFFERENCE OF ≥5% ALL GRADES) IN PSMAfore2
mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen.
aThe denominator used to calculate the rate for each laboratory parameter was based on 226 patients with a baseline value and at least 1 posttreatment value.
bThe denominator used to calculate the rate for each laboratory parameter varied from 231 to 232 based on the number of patients with a baseline value and at least 1 post-treatment value.
cNo grade 4 laboratory abnormalities worsening from baseline were reported.