With the Evolution of Metastatic
Melanoma Treatment IT’S TIME TO RAISE EXPECTATIONS
vs YERVOY1,2 Long-term durable
survival at 4 years1,3*
*From the Checkmate 067 exploratory analysis at 4 years, OS for OPDIVO + YERVOY was 53%, 46% for OPDIVO, and 30% for YERVOY. mOS was not
reached for OPDIVO + YERVOY (95% CI: 38.2–NR), and 36.9 months with OPDIVO (95% CI: 28.3–NR) vs 19.9 months with YERVOY (95% CI: 16.9–24.6). In the primary analysis at 28 months, the HR comparing OPDIVO + YERVOY vs YERVOY was 0.55 (95% CI: 0.44–0.69); P<0.0001 and OPDIVO vs YERVOY was 0.63 (95% CI: 0.50–0.78); P<0.00011,3
CHECKMATE 067 Information1
- OPDIVO + YERVOY was evaluated in a double-blind, randomized study of previously untreated, unresectable or metastatic melanoma. Patients were
randomized (1:1:1) to receive OPDIVO + YERVOY (OPDIVO 1 mg/kg and YERVOY 3 mg/kg q3w x 4 doses, followed by OPDIVO monotherapy 3 mg/kg q2w†) or OPDIVO 3 mg/kg q2w or YERVOY 3 mg/kg q3w x 4 doses plus placebo. Major efficacy outcome measures were investigator-assessed overall survival and overall survival. Additional efficacy outcome measures were confirmed overall response rate and
duration of response
†The recommended dose of OPDIVO is 1 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 3 mg/kg administered as an intravenous infusion over 90 minutes on the same day, every 3 weeks for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer OPDIVO as a single agent, either 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.1
Select Important Safety Information
In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313).
The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). The most frequent adverse reactions leading to discontinuation of both drugs in the OPDIVO + YERVOY arm and of OPDIVO in the OPDIVO arm, respectively, were colitis (10% and 0.6%), diarrhea (8% and 2.2%), and increased ALT (4.8% and 1.0%), increased AST (4.5% and 0.6%), and pneumonitis (1.9% and 0.3%).
In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritis (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritis (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).
OPDIVO + YERVOY may experience
serious adverse reactions. See Selected Safety Profile