Ipilimumab Plus Chemotherapy is Associated with Prolonged Survival and Increased Disease Control Rates in Patients with Advance...(C versus DTIC alone inpreviously-untreat...),Health

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.

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