Bristol-Myers Squibb Co Announces New Four- and Five-Year Survival Data for YERVOY (ipilimumab) in Treatment-Naïve and Previously-Treated Metastatic Melanoma

Bristol-Myers Squibb Co announced four- and five-year survival rates based on long-term follow up from Phase 3 and Phase 2 YERVOY (ipilimumab) clinical trials in patients with treatment-naïve and previously-treated metastatic melanoma. In the Phase 3 trial (024), patients who had not previously received treatment for metastatic melanoma (n=502) were randomized to receive either the investigational dose of YERVOY 10 mg/kg in combination with dacarbazine (DTIC, 850 mg/m2) or DTIC alone. Long-term follow-up from this study demonstrated that treatment with YERVOY plus DTIC resulted in a four-year survival rate of 19.0% compared to 9.6% for DTIC alone. Additionally, the overall survival data appeared relatively stable between years three and four for patients treated with YERVOY plus DTIC. The three and four-year survival rates for patients treated with placebo plus DTIC were 12.1% and 9.6%, respectively. In three Phase 2 trials (007 [n=115], 008 [n=155] and 022 [n=217]) in which five-year follow-up data are available through a rollover study (025), patients received YERVOY at 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg. No comparator treatment arms were included in these studies. In treatment-naïve patients, the five-year estimated survival rates ranged from 38% to 49%, which was unchanged from the four-year rates. In previously-treated patients, the five-year estimated survival rates (12% to 28%) were relatively stable compared to the rates at four years (14% to 28%).