Ipilimumab Plus Chemotherapy is Associated with Prolonged Survival and Increased Disease Control Rates in Patients with Advanced Melanoma
Sunday June 1, 3:15 pm ET
Updated Clinical Phase 2 data presented at American Society of Clinical Oncology Annual Meeting
PRINCETON, N.J., June 1 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced updated long-term follow-up and overall survival (OS) results from a Phase 2 clinical study (MDX010-08) of 3 mg/kg of ipilimumab in combination with dacarbazine (DTIC) where 11.4%, or 4 of 35 patients, were still alive at or greater than 4 years of follow-up. This included 1 patient that experienced a complete response (4.7 years), 1 patient that experienced a partial response (4.2 years), 1 patient with stable disease (4.6 years) and 1 patient with RECIST defined progressive disease (4.4 years). The median OS for patients treated with ipilimumab in combination with DTIC was 15 months in this study. These results compare favorably with data in medical literature, in which median OS ranges from 6 to 9 months for patients with treated or previously untreated advanced melanoma treated with standard chemotherapy. These findings were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL May 30-June 3, 2008. (Abstract # 9022)
"The long-term survival data suggests that ipilimumab in combination with DTIC may have long-lasting effects," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "With a median survival of approximately 15 months in the patients treated with 3 mg/kg of ipilimumab in combination with DTIC in this Phase 2 study, we look forward with interest to the outcome of the ongoing Phase 3 study being performed by our collaborator Bristol-Myers Squibb Company, comparing 10 mg/kg of ipilimumab in combination with DTIC versus DTIC alone in previously-untreated patients with advanced melanoma."
In the Phase 2 trial (MDX010-08), 72 chemotherapy-naive patients with advanced melanoma were treated with 3 mg/kg of ipilimumab monthly for four months and were randomized to receive either ipilimumab in combination with DTIC (n=35) or ipilimumab alone (n=37). Patients originally treated in the MDX010-08 study were subsequently enrolled into study MDX010-028 to determine long-term follow-up data and OS. The disease control rate (proportion of patients with complete responses, partial responses or stable disease) for patients treated with ipilimumab in combination with DTIC was 37.1%, or 13 of 35 patients, with 2 complete responses, 3 partial responses and 8 patients with stable disease. Two of 37 patients, or 5.4%, treated with 3 mg/kg of ipilimumab alone experienced partial responses, which were ongoing more than 4 years and 4.2 years in duration, respectively. The disease control rate in the ipilimumab alone treatment arm was 21.6%, or 8 of the 37 patients, with median OS of 12 months.
Ipilimumab is being developed through a joint partnership between Bristol-Myers Squibb and Medarex. Based on preclinical and clinical studies showing that antibody blockade of CTLA-4 plays an important role in sustaining an active immune response to fight cancer, the companies are pursuing a broad clinical development program with ipilimumab. More than 2,000 patients have been treated in clinical trials with ipilimumab as a monotherapy or in combination with other agents. Patients in the ongoing Phase 3 study (BMS study CA184-024) are randomized to receive induction therapy with 10 mg/kg of ipilimumab in combination with DTIC or placebo. Eligible patients are permitted maintenance dosing with ipilimumab or placebo after the induction phase has been completed. |
