Michael Rotkowitz, MD, from Cancer Treatment Centers of America, discusses a phase III trial that examined ipilimumab plus dacarbazine for patients with metastatic melanoma.
Michael Rotkowitz, MD, medical oncologist, Cancer Treatment Centers of America, Eastern Regional Medical Center, discusses a phase III trial that was presented at the 2012 ESMO Congress that examined the immunotherapy ipilimumab (Yervoy) plus dacarbazine for patients with metastatic melanoma.
In the trial, 502 patients with unresectable metastatic melanoma received dacarbazine at 850 mg/m2 for 22 weeks and were further randomized 1:1 to receive either 10 mg/kg of ipilimumab or placebo on weeks 1, 4, 7, and 10. At a long-term follow-up, the trial demonstrated an improvement in overall survival (OS) of 19.0% for patients receiving ipilimumab compared to 9.6% in the control arm.
Rotkowitz explains that the 10 mg/kg dose of ipilimumab administered in this trial is controversial, since the approved dose for metastatic melanoma is 3 mg/kg. However, this trial has demonstrated benefits for using 10 mg/kg and has shown sustainable 3- and 4-year survival data for the first time in metastatic melanoma.