BioCentury
ARTICLE | Clinical News

Anyara naptumomab estafenatox: Phase II/III data

February 4, 2013 8:00 AM UTC

Top-line data from a European Phase II/III trial in 513 patients with advanced RCC showed that Anyara plus interferon (IFN) alpha missed the primary endpoint of improving OS vs. IFN alpha alone. Active Biotech said that an unexpected majority of patients had high levels of pre-formed antibodies against the superantigen component of Anyara. In a subgroup analysis of the 25% of patients with low or normal levels of baseline IL-6 and expected anti-superantigen antibody levels, Anyara plus IFN alpha significantly improved OS (HR=0.59, p=0.02) and the secondary endpoint of PFS (p-value not disclosed) vs. IFN alpha alone. The most common Anyara-related adverse events were grade 1/2 fever, nausea and vomiting. No new or unexpected safety concerns were identified. The company expects to submit the data for presentation at a medical meeting this year. ...