YERVOY

First-line treatment

YERVOY™, for long-term survival in advanced melanoma, now approved in first line. You can now start with YERVOY™ first! 1-6

Kaplan-Meier of overall survival up to 24 months

YERVOY® overall survival results are generally consistent across therapeutic lines

 

  CA184-3385 CA184-3326 Pooled chemo-naïve Phase II/III data3
Number of patients 120 61 78
Primary objective To assess:
• Patient and disease characteristics
• Patterns of care
• Safety
• Outcomes of treatment-naïve advanced melanoma patients
To assess:
• Patient and disease characteristics
• Patterns of care
• Outcomes initiating treatment in a U.S. community-based setting of treatment-naïve advanced melanoma patients
To assess:
• Patient and disease characteristics
• Patterns of care
• Safety
• Outcomes initiating treatment in pooled Phase II/III studies of chemo-naïve advanced melanoma patients
Key inclusion criteria • Unresectable or metastatic melanoma ≥18 years of age at diagnosis of metastatic melanoma
• Patients from multiple U.S. centers who:
– had received ≥1 prior dose(s) of YERVOY®
– ≥12 months had elapsed since YERVOY® initiation
• Unresectable or metastatic melanoma >11 years of age at diagnosis of metastatic melanoma
• Patients from multiple U.S. centers who:
– had received ≥1 prior dose(s) of YERVOY®
– ≥12 months had elapsed since YERVOY® initiation
• Chemo-naïve (MDX010-08), previously treated (MDX010-20,CA184-022), advanced melanoma (CA184-004)
• ECOG 0-1, KPS ≥ 60% (MDX010-08)
Key exclusion criteria • Prior therapy for advanced melanoma
• Participation in a clinical trial
• Current use of another treatment for a treatment of cancer other than melanoma
• Prior therapy for advanced melanoma
• Participation in a clinical trial
• Current use of another treatment for cancer other than melanoma
• Ocular melanoma (CA184-004,MDX010-20)
• Mucosal melanoma (CA184-022)
• Untreated brain metastases
(MDX010-020, CA184-004) • Any brain metastases (CA184-022)
Precise dosing 3 mg/kg every 3 weeks 3 mg/kg every 3 weeks 3 mg/kg every 3 weeks
Study design Retrospective, observational study Retrospective, observational study Phase II/III studies

YERVOY® in a first-line setting: characteristic of patients in CA184-338 study

YERVOY® for first-line advanced melanoma patients: Kaplan-Meier estimate
for overall survival in CA184338 study – interim analysis

YERVOY® in a first-line setting: characteristic of patients in CA184-332 study

Download poster CA184-338
Download poster CA184-332
Download poster pooled phase 2/3 chemo data
Download abstract pooled phase 2/3 chemo data

1 YERVOY™ Summary of Product Characteristics.
2 Hodi FS et al. N Engl J Med. 2010;363:711–23.
3 European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Assessment Report For YERVOY™ (ipilimumab) 24 October 2013.
4 Eggermont AM et al. Eur J Cancer. 2011;47:2150–7.
5 Margolin KA et al. Poster presented at the European Cancer Congress (ECCO-ESMO-ESTRO), 27 Sep–1 Oct 2013, Amsterdam, Netherlands.
6 Patt D et al. Poster presented at the European Cancer Congress (ECCO-ESMO-ESTRO), 27 Sep–1 Oct 2013, Amsterdam, Netherland
7 Data on file.

Senast uppdaterad:  2015-07-02Ansvarig:  Anna Labecker