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news.Medarex has announced data from a Phase I/II trial that suggested a potential association between higher doses of MDX-060, an investigational anti-CD30 antibody, and improvement in disease control and prolonged progression-free survival in patients with relapsed or refractory CD30- positive lymphomas.
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In the completed dose-escalation Phase I/II trial, 72 patients with relapsed or refractory CD30-positive lymphoma received weekly doses of MDX-060 (0.1, 1, 4, 10 or 15mg/kg) for four weeks. Of the 33 patients treated at the two highest doses of MDX-060, disease control was observed in 51% of patients (three complete responses, 14 stable disease), with median progression- free survival of 3.7 months and 39% of patients with no evidence of disease progression four months post-treatment.
Of the 39 patients treated at the three lowest doses of MDX-060, disease control was observed in 33% of patients (one complete response, two partial responses, 10 stable disease), with median progression-free survival of less than two months and 18% of patients with no evidence of disease progression four months post-treatment. MDX-060 treatment was well-tolerated with no clinically meaningful infusion reactions.
Howard Pien, president and CEO of Medarex, said: “We look forward to analyzing these results alongside the Phase II proof-of-concept chemotherapy combination data that is expected later in the year.”