Medarex begins registrational trial of ipilimumab for metastatic melanoma

By Lisa Kerner

Erie, Pa., March 31 - Medarex, Inc. said it began a registrational clinical trial of ipilimumab (known as MDX-010) used as a monotherapy in second-line metastatic melanoma patients.

About 150 patients with unresectable stage 3 or stage 4 metastatic melanoma who have progressed after another melanoma treatment other than ipilimumab are expected to enroll in the open label, single-arm trial at about 80 centers worldwide.

Patients will receive a dose of 10 mg/kg of ipilimumab once every three weeks for up to four doses, followed by a 12 week maintenance phase for eligible patients, according to a company news release.

Medarex said the study is designed to assess best objective response rate (complete and partial responses) as the primary endpoint.

Secondary endpoints include disease control rate, disease progression and survival data, and duration of best objective responses.

"We and our partner, Bristol-Myers Squibb, are committed to the rapid and strategic development of ipilimumab and are pleased with the initiation of this second-line ipilimumab registrational study for late stage metastatic melanoma," president and chief executive officer Donald L. Drakeman said in the release.

"With this monotherapy registrational trial, pending favorable results, we believe that we are well positioned to file the initial BLA application for market approval next year."

Ipilimumab is a fully human antibody against human CTLA-4, a molecule on T cells possibly responsible for suppressing the immune response, the release stated.

Multiple phase 2 clinical trials are investigating ipilimumab in other tumor types and in combination studies with chemotherapy, immunotherapy and vaccines.

Located in Princeton, N.J., Medarex discovers, develops and commercializes fully human antibody-based therapeutics to treat cancer, inflammation, autoimmune disorders and infectious diseases.

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