Results from Active Biotech's Phase II/III ANYARA trial for the treatment of renal cell cancer
January 28, 2013 - LUND, SWEDEN
* The primary endpoint - to show a survival advantage in the intention totreat(ITT) population - was not reached.
* In a subgroup analysis, patients with low/normal baseline IL-6 andexpectedanti-superantigen antibody levels demonstrated proof of concept with ANYARAtreatment comprising both a significantly prolonged overall survival (OS;p=0.02, HR=0.59) and Progression Free Survival (PFS).
Active Biotech (NASDAQ OMX NORDIC: ACTI)announced today the initial results from the ANYARA Phase II/III clinicalstudy.The study encompassed 513 patients and was designed to evaluate the effectofANYARA in combination with interferon-alpha, compared with interferon-alphaalone, in patients with advanced renal cell cancer. The primary endpointwasoverall survival (OS).
The results showed that the ANYARA Phase II/III study did not achieve itsprimary endpoint to show a prolonged OS in the ITT population.Unexpectedly, andin contrast to previous studies in other territories, a majority of thepatientsin the current study had high levels of pre-formed antibodies against thesuperantigen component of ANYARA. A subgroup analysis, excluding patientswithhigh levels of pre-formed antibodies, resulted in a trend for survivalbenefitwith ANYARA treatment. Furthermore, baseline levels of the biomarker IL-6wasshown to be an important predictive marker for a positive treatment effectofANYARA.
In a hypothesis generating subgroup analysis, the 25 % of patients withlow/normal levels of base line IL-6 and expected anti-superantigen antibodylevels, showed a statistically significant treatment advantage on both OS(p=0.02, HR=0.59) and PFS. In North America and Western Europe, thissubgroupaccount for 40-50% of the total number of advanced renal cell cancerpatients.
"The presence of pre-formed antibodies in a high number of patients wasunexpected and we are disappointed that the primary endpoint of this trialwasnot reached. However, there is a treatment effect in a significant subgroupofpatients, and this observation is congruent with ANYARAs mode of action"saidTomas Leanderson, President & CEO Active Biotech. "Based on these data, wewillseek a partner for the continued development of this unique, targeted,immunetherapy".
The safety profile was good and in line with previous observations; themostcommon adverse events associated with ANYARA treatment were grade 1-2fever,nausea or vomiting. No new and unexpected safety concerns were identifiedin thestudy.
Additional analyses of the ANYARA Phase II/III study data are ongoing, andresults will be submitted for presentation at a scientific congress laterin theyear. The company will also discuss future development strategies withmajorregulatory authorities.
ABOUT THE ANYARA PHASE II/III STUDY
The Phase II/III study was designed to evaluate the effect of ANYARA incombination with interferon-alpha, compared with interferon-alpha alone, inpatients with advanced renal cell cancer. The primary endpoint was overallsurvival (OS). In May 2008, a positive interim analysis of safety andefficacywas performed and the study continued into the Phase III part. Enrollmentof513 patients was completed in June 2009 and recruited patients fromapproximately 50 sites in Europe (UK, Ru, Uk, Bu, Ro). Secondary endpointsinthe study were Progression Free Survival (PFS) and safety.
ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes thetreatmentof cancer tumor-specific. The development of ANYARA is mainly focused onrenalcell cancer. Positive data was reported from clinical Phase I trials inlungcancer, renal cell cancer and pancreatic cancer. In July 2009, the resultsfromtwo Phase I studies of ANYARA were published in the Journal of ClinicalOncology, where ANYARA was studied both as a single agent (monotherapy) andincombination with an established Tumor therapy - docetaxel (Taxotere®)- inpatients with advanced cancer. The results showed that ANYARA was welltoleratedboth as monotherapy and in combination with docetaxel. ANYARA has beengrantedorphan-drug status by the EMA for the indication renal cell carcinoma.
ABOUT RENAL CELL CARCINOMA
Renal Cell Carcinoma (RCC) affects approximately 180,000 people worldwideeachyear. Half of patients are affected by metastases. If the disease hasmetastasized, average survival is around 2 years. The survival rate ofpatientsdiagnosed with renal cancer is only 5-15% after five years. The market fortreatment of RCC is estimated at approximately USD 2.7 billion per year(EvaluatePharma March 2012). Approved first line treatments are Sutent,Avastin+ IFN, Torisel and Votrient. Approved for second line treatment are NexavarandEverolimus.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in pivotalphaseare laquinimod, an orally administered small molecule with uniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQforprostate cancer and ANYARA primarily for the treatment of renal cellcancer. Inaddition, laquinimod is in Phase II development for Crohn's and Lupus. Thecompany also has one additional project in clinical development, the orallyadministered compound 57-57 for Systemic Sclerosis. Please visitwww.activebiotech.com for more information.
Active Biotech is obligated to publish the information contained in thispressrelease in accordance with the Swedish Securities Market Act. Thisinformationwas provided to the media for publication 8:30 a.m. CET on January 28,2013.
Results from Active Biotech's Phase II/III ANYARA trial :
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