September 16, 2008
Bristol-Myers Announces Updated Survival Data From Phase II Melanoma Studies
Bristol-Myers Squibb Company and Medarex have announced updated survival data from three Phase II studies of ipilimumab in patients with advanced metastatic melanoma who had previously been treated.
Study results show that approximately half of patients who received ipilimumab (10mg/kg) remained alive beyond one year. The results are based on follow-up of the patient population from studies 008, 022 and 007 treated with 10mg/kg of ipilimumab (induction and maintenance) and show a consistent one-year survival rate between 47 and 51%.The results show one-year survival rate of 47% in patients who had progressed while on or after receiving standard treatment, one-year survival rate of 48% in patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies and one-year survival rate of 51% in patients previously treated with therapy other than ipilimumab.
Safety results from the three studies were generally consistent with data from previously reported clinical trials of ipilimumab. Additional data on efficacy and survival with an active control group will come from an ongoing Phase III, randomized, double-blind study (024) assessing ipilimumab (10mg/kg) in combination with dacarbazine (DTIC) versus DTIC alone in patients with untreated, unresectable stage III or stage IV metastatic melanoma.
A Phase III study (029) of ipilimumab administered as adjuvant therapy in patients with high-risk stage III metastatic melanoma is also currently being conducted.
Geoffrey Nichol, senior vice president of product development at Medarex, said: "We are excited by the consistent one-year survival rates among the three Phase II studies. Medarex and Bristol-Myers Squibb remain fully committed to the registrational program, including advanced melanoma, adjuvant melanoma, lung and prostate cancer trials."