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A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma
European Journal of Cancer
To evaluate the efficacy and safety of ramucirumab (IMC-1121B; LY3009806), a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2, alone and in combination with dacarbazine in chemotherapy-naïve patients with metastatic melanoma (MM).
Eligible patients received ramucirumab (10 mg/kg) + dacarbazine (1000 mg/m2) (Arm A) or ramucirumab only (10 mg/kg) (Arm B) every 3 weeks. The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), overall response and safety.
Of 106 randomised patients, 102 received study treatment (Arm A, N = 52; Arm B, N = 50). Baseline characteristics were similar in both arms. Median PFS was 2.6 months (Arm A) and 1.7 months (Arm B); median 6-month PFS rates were 30.7% and 17.9% and 12-month PFS rates were 23.7% and 15.6%, respectively. In Arm A, 9 (17.3%) patients had partial response (PR) and 19 (36.5%), stable disease (SD); PR and SD in Arm B were 2 (4.0%) and 21 (42.0%), respectively. Median OS was 8.7 months in Arm A and 11.1 months in Arm B. Patients in both arms tolerated the treatment with limited Grade 3/4 toxicities.
Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM. Although the study was not powered for comparison between treatment arms, PFS appeared greater with combination therapy. Sustained disease control was observed on both study arm.
Keywords: Metastatic melanoma, Phase II, Ramucirumab.
a Memorial Sloan-Kettering Cancer Center, New York, NY, USA
b USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA
c Seattle Cancer Care Alliance, Seattle, WA, USA
d Pinnacle Oncology Hematology, Scottsdale, AZ, USA
e University of Colorado Denver, Aurora, CO, USA
f New York University, New York, NY, USA
g ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA
h MD Anderson Cancer Center, Houston, TX, USA
Presented in part at the American Society of Clinical Oncology, Chicago, IL, USA, June 2010; and the 37th European Society for Medical Oncology, Vienna, Austria, September 2012.
Clinical Trial ID: NCT00533702 , ClinicalTrials.gov.
© 2014 Elsevier Ltd, All rights reserved.