Detailed analysis further supports effect of ANYARA in a biomarker defined subgroup
Lund( Sweden), September 12, 2013. Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that a biomarker trend analysis of overall survival (OS) and Progression Free Survival (PFS) from the ANYARA Phase II/III study in renal cell cancer will be presented at the scientific conference " European Cancer Congress2013" (ECCO-ESMO-ESTRO) held in Amsterdam, the Netherlands, September 27 - October 1. Professor Tim Eisen, Department of Oncology, Cambridge UniversityHospitals NHS Foundation Trust, UK, will present "Baseline biomarker trend analysis of a randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha vs IFN-alpha in advanced renal cell carcinoma *". The detailed analysis gives further support to the previous findings that low baseline levels of pre-formed antibodies against ANYARA or low levels of the cytokine IL-6, independently predict anti-tumor efficacy after ANYARA+IFN-alpha treatment. The results also highlight the potential role of IL-6 as a predictive factor for the outcome of immunotherapy of cancer in general. The analysis showed clear trends of increased OS (decreasing Hazard Ratios, "HR"s) in patients with decreasing IL-6 and anti-ANYARA antibodies. Similar trends were seen for PFS HRs. For more detailed information, please see http://eccamsterdam2013.ecco- org.eu/. The presentation will be available on Active Biotech's web site www.activebiotech.com. * T. Eisen, G. Hedlund, G. Forsberg, Ö. Nordle, R. Hawkins. ABOUT THE ANYARA PHASE II/III STUDY The Phase II/III study encompassed 513 patients from approximately 50 sites in Europe( UK, Ru, Uk, Bu, Ro) and was designed to evaluate the effect of ANYARA (naptumomab estafenatox) in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was overall survival (OS). Secondary endpoints were Progression Free Survival (PFS) and safety. The results were presented at ASCO in June 2013. High baseline levels of pre-formed antibodies against superantigens were shown to decrease ANYARA levels while the biomarker IL-6 was suggested to be a predictive marker for immune therapies. Although the study did not achieve its primary endpoint to show a prolonged OS in the overall ITT population, the addition of ANYARA to interferon-alpha improves OS and PFS in a biomarker defined subgroup. In this subgroup, patients with high levels of pre-formed antibodies against superantigens or the cytokine IL-6 were excluded. In this subgroup of 130 patients, the median OS for the ANYARA vs. placebo treatment arm were 63.3 vs. 31.1 months (HR: 0.59; p=0.020), respectively. The median PFS were 13.7 (ANYARA) vs. 5.8 (placebo) months (HR: 0.62; p=0.016).