active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Yervoy/placebo was administered at 3 mg/kg as an intravenous infusion every 3 weeks for 4 doses. Gp100/placebo was administered at a dose of 2 mg peptide by deep subcutaneous injection every 3 weeks for 4 doses. Assessment of tumor response was conducted at weeks 12 and 24, and every 3 months thereafter. Patients with evidence of objective tumor response at 12 or 24 weeks had assessment for confirmation of durability of response at 16 or 28 weeks, respectively.
The major efficacy outcome measure was overall survival (OS) in the Yervoy+gp100 arm compared to that in the gp100 arm. Secondary efficacy outcome measures were OS in the Yervoy+gp100 arm compared to the Yervoy arm, OS in the Yervoy arm compared to the gp100 arm, best overall response rate (BORR) at week 24 between each of the study arms, and duration of response.
Of the randomized patients, 61%, 59%, and 54% in the Yervoy+gp100, Yervoy, and gp100 arms, respectively, were men. Twenty-nine percent were ≥65 years of age, the median age was 57 years, 71% had M1c stage, 12% had a history of previously treated brain metastasis, 98% had ECOG performance status of 0 and 1, 23% had received aldesleukin, and 38% had elevated LDH level. Sixty-one percent of patients randomized to either Yervoy-containing arm received all 4 planned doses. The median duration of follow-up was 8.9 months.
The OS results are shown in Table 3 and Figure 1.
Table 3: Overall Survival Results a Not adjusted for multiple comparisons.
Yervoy
n=137 Yervoy+gp100
n=403 gp100
n=136
Hazard Ratio (vs. gp100) 0.66 0.68
(95% CI) (0.51, 0.87) (0.55, 0.85)
p-value p=0.0026a p=0.0004
Hazard Ratio (vs. Yervoy) 1.04
(95% CI) (0.83, 1.30)
Median (months) 10 10 6
(95% CI) (8.0, 13.8) (8.5, 11.5) (5.5, 8.7)
Figure 1: Overall Survival
The best overall response rate (BORR) as assessed by the investigator was 5.7% (95% CI: 3.7%, 8.4%) in the Yervoy+gp100 arm, 10.9% (95% CI: 6.3%, 17.4%) in the Yervoy arm, and 1.5% (95% CI: 0.2%, 5.2%) in the gp100 arm. The median duration of response was 11.5 months in the Yervoy+gp100 arm and has not been reached in the Yervoy or gp100 arm.
HOW SUPPLIED/STORAGE AND HANDLING
Yervoy is available as follows:
Carton Contents NDC
One 50 mg vial (5 mg/mL), single-use vial NDC 0003-2327-11
One 200 mg vial (5 mg/mL), single-use vial NDC 0003-2328-22
Store Yervoy under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect vials from light.
PATIENT COUNSELING INFORMATION
See MEDICATION GUIDE.
Inform patients of the potential risk of immune-mediated adverse reactions.
Advise patients to read the Yervoy Medication Guide before each Yervoy infusion.
Advise women that Yervoy may cause fetal harm.
Advise nursing mothers not to breastfeed while taking Yervoy.
Manufactured by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
U.S. License No. 1713
1281558A4
Rev May 2013
MEDICATION GUIDE
Yervoy® (yur-voi)
(ipilimumab)
Read this Medication Guide before you start receiving Yervoy and before each infusion. There may be new information. This Medication Guide does not take the place of talking with you
