YERVOY was studied in patients with a typically poor prognosis, including those with brain metastases, elevated LDH, and visceral disease (M1c). In the study, 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 aldeskeukin and 38% had elevated LDH level. Additionally, 29% of patients were 65 years or older with a median age of 57 years.The median duration of follow-up was 8.9 months.
Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY armvs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%[2] (95% CI: 8.0, 20.0) in the gp100 arm. Patients treated with YERVOY had a 34% reduction in the risk of death over the gp100 control arm (HR = 0.66 [95% CI: 0.51-0.87], P=0.0026). Patients treated with YERVOY (ipilimumab) plus gp100 had a 32% reduction in the risk of death over the gp100 control arm (HR = 0.68 [95% CI: 0.55-0.85], P=0.0004). Median overall survival was 10 (95% CI: 8.0-13.8), 14 Jul. (95% CI: 8.5-11.5) - and 6 (95% CI: 5.5-8.7) months for the YERVOY alone, YERVOY + gp100 arm and gp100 alone arms, respectively.
In patients who received 3 mg/kg YERVOY alone (n=131), severe to fatal immune-related adverse reactions were reported and included enterocolitis (7%), endocrinopathy (4%, all of which had hypopituitarism), dermatitis (2%), hepatitis (1%), neuropathy (1%), nephritis (1%), and eosinophilia (1%).In patients who received 3 mg/kg of YERVOY + gp100 (n=380) severe to fatal immune-related adverse reactions were reported and included enterocolitis (7%), hepototoxicity (2%), dermatitis (3%), endocrinopathy (1%, hypopituitarism, 1% adrenal insufficiency), pneumonitis (<1%), meningitis (<1%), pericarditis (<1%).The most common adverse reactions were fatigue (41%), diarrhoea (32%), pruritus (31%), rash (29%) and colitis (8%) for the YERVOY alone arm, diarrhoea (37%), fatigue (34%), rash (25%), pruritus (21%), and colitis (5%) for the YERVOY +gp100 arm, and fatigue (31%), diarrhoea (20%), pruritus (11%), rash (8%), and colitis (2%) for gp100 arm. YERVOY therapy was discontinued for adverse reactions in 10% of patients.
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CONTACT: Media Contact: Elzbieta Zawislak, +33-615-523-580,elzbieta.zawislak@bms.com
