Active Biotech's project ANYARA improved overall survival in a subgroup of renal cell cancer patientsJune 3, 2013 15:00 (CEST)
Phase II/III Overall Survival and PFS data presented at the 2013 ASCO Annual Meeting
Lund (Sweden), June 3, 2013. Active Biotech (NASDAQ OMX NORDIC: ACTI) today presented overall survival (OS) and Progression Free Survival (PFS) data from the ANYARA Phase II/III study in renal cell cancer at the scientific conference "2013 ASCO Annual Meeting" held in Chicago (USA).
The coordinating investigator Professor Robert Hawkins presented "A randomized phase II/III study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha in advanced renal cell carcinoma*".
The study encompassed 513 patients 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).
The results showed that although the ANYARA Phase II/III 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. High baseline levels of these antibodies were shown to decrease ANYARA levels while the biomarker IL-6 has previously been suggested to be a predictive marker for immune therapies.
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).
To test the robustness of these data, an alternative subgroup of 131 patients, based on previously published cut-off levels of these biomarkers, was investigated. In this subgroup, the median OS for ANYARA in combination with interferon-alpha versus interferon-alpha alone were 30.4 and 21.7 months (HR=0.65, (p=0.036), respectively. The median PFS of ANYARA in combination with interferon-alpha versus interferon-alpha alone were 8.5 and 5.8 months (HR=0.75, p=0.162), respectively.
Professor Robert Hawkins, the Christie Hospital, Manchester, UK said: "As shown with other immune therapies, patients may be pre-selected using biomarkers to increase their chances to obtain treatment benefits. The results from this study with ANYARA were striking and should be confirmed".
Tomas Leanderson, President & CEO Active Biotech, added: "Based on these encouraging results, we are seeking a partner for the continued development of this unique, targeted cancer therapy".
* R. Hawkins, M. Gore, Y. Shparyk, V. Bondar, O. Gladkov, T. Ganev, M. Harza, S. Polenkov, I. Bondarenko, P. Karlov, O. Karyakin, R. Khasanov, G. Hedlund, G. Forsberg, Ö. Nordle, T. Eisen.
ABOUT THE ANYARA PHASE II/III STUDY
The Phase II/III study was designed to evaluate the effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was overall survival (OS). In May 2008, a positive interim analysis of safety and efficacy was performed and the study continued into the Phase III part. Enrollment of 513 patients was completed in June 2009 and recruited patients from approximately 50 sites in Europe (UK, Ru, Uk, Bu, Ro). Secondary endpoints in the study were Progression Free Survival (PFS) and safety.
ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes the treatment of cancer tumor-specific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. In July 2009, the results from two Phase I studies of ANYARA were published in the Journal of Clinical Oncology, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy - docetaxel (Taxotere®) - in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel. ANYARA has been granted orphan-drug status by the EMA for the indication renal cell carcinoma.
ABOUT RENAL CELL CARCINOMA
Renal Cell Carcinoma (RCC) affects approximately 180,000 people worldwide each year. Approximately 50 % of the patients are affected by metastases. If the disease has metastasized, average survival is around 2 years. The survival rate of patients diagnosed with renal cancer is only 5-15% after five years. The market for treatment of RCC is estimated at approximately USD 2.7 billion per year (EvaluatePharma March 2012). Approved first line treatments are Sutent, Avastin in combination with IFN, Torisel and Votrient. Approved for second line treatment are Nexavar and Everolimus.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod for prostate cancer and ANYARA primarily for the treatment of renal cell cancer. In addition, laquinimod is also in Phase II development for Crohn's and Lupus. The company also has one additional project in clinical development, the orally administered compound paquinimod (57-57) for systemic sclerosis. Please visit www.activebiotech.com for more information.
For further information:
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
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Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication 3:00 pm CET on June 3, 2013.