PLUVICTO Demonstrated a Predictable Safety Profile
Rates of grade ≥3 adverse reactions were similar between patients receiving PLUVICTO + androgen receptor pathway inhibitor (ARPI) and those receiving ARPI alone (Incidence of grade ≥3 TEARs: 50.7% with PLUVICTO + ARPI vs 43% with ARPI). These findings may help inform treatment planning by characterizing the safety profile of PLUVICTO in combination with ARPI.1,2
Adverse Reactions
PSMAddition: A study of PLUVICTO in mAPMN/S PC (mHSPC)
ARs of grades ≥3 occurred at similar rates between study arms2
Incidence of grade ≥3 TEARs: 50.7% (n=286) with PLUVICTO + ARPI vs 43% (n=243) with ARPI
ADVERSE REACTIONS OCCURRING AT ≥10% INCIDENCE IN PATIENTS WHO RECEIVED PLUVICTO IN COMBINATION WITH ARPI OR ARPI IN PSMAddition1
| PLUVICTO + ARPI | ARPI | |||
Adverse reactions | All grades | Grades 3 or 4 | All grades | Grades 3 or 4 | |
General disorders | 51 14 | 1.4 0.9 | 41 7 | 1.8 0.2 | |
| Fatiguea Decreased appetite | ||||
Gastrointestinal disorders | 46 34 18 14 12 | 0 0.2 0 0.7 0.2 | 3.7 9 16 3.7 10 | 0 0 0 0 0 | |
| Dry moutha Nausea Constipation Vomitinga Diarrhea | ||||
Nervous system disorders | 13 12 | 0 0 | 4.1 9 | 0 0.4 | |
| Dysgeusiaa Headache | ||||
AR, adverse reaction; mAPMN/S PC, metastatic androgen pathway modulation-naive or -sensitive prostate cancer; TEAR, treatment-emergent adverse reaction.
aIncludes multiple similar terms.
PLUVICTO was permanently discontinued due to adverse reactions in 8% of patients who received PLUVICTO in combination with ARPI1
Clinically relevant adverse reactions in <10% of patients who received PLUVICTO in combination with ARPI included abdominal pain, dizziness, acute kidney injury, dry eye, dry skin, stomatitis, gastroesophageal reflux disease, vertigo, eye irritation, oral fungal infection, dysphagia, and esophagitis1
Laboratory Abnormalities Reported in the PSMAddition Trial
SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE IN PATIENTS WHO RECEIVED PLUVICTO IN COMBINATION WITH ARPI OR ARPI (BETWEEN-ARM DIFFERENCE OF ≥5% ALL GRADES) IN PSMAddition1
| PLUVICTO + ARPIa | ARPIb | |||
Laboratory abnormalities | All grades | Grades 3 or 4 | All grades | Grades 3 or 4 | |
Hematology | 91 72 41 23 | 24 4.3c 4.4 1.1 | 61 46 30 9 | 10 2.5c 3 1.1 | |
| Decreased lymphocytes Decreased hemoglobin Decreased neutrophils Decreased platelets | ||||
Chemistry | 43 | 1.8 | 44 | 1.1 | |
| Decreased eGFRd | ||||
eGFR, estimated glomerular filtration rate.
aThe denominator used to calculate the rate for each laboratory parameter varied from 563 to 564 based on the number of patients with a baseline value and at least one posttreatment value.1
bThe denominator used to calculate the rate for each laboratory parameter varied from 557 to 558 based on the number of patients with a baseline value and at least one posttreatment value.1
cNo grade 4 laboratory abnormalities worsening from baseline were reported.1
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.1