ANYARA – unique substances for use in fighting cancer

ANYARA is a protein drug that makes the treatment of cancer tumor-specific. The development of ANYARA is primarily focused on renal cell cancer, but the compound has also demonstrated favorable results in connection with the treatment of, for example, non-small cell lung cancer. The compound is currently undergoing pivotal Phase III trials encompassing just over 500 renal cell cancer patients.

Renal cancer

Renal Cell Carcinoma ("RCC") affects approximately 180,000 people worldwide each year. Half of 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 5-10% after five years (Cowen & Co, Therapeutic Categories Outlook, March 2009).  

RCC is traditionally treated with relatively high doses of the cytokines interferon-alpha or interleukin-2. The market for treatment of RCC is estimated at approximately USD 1 billion per year (GlobalData 2010). Recently approved treatments are Sutent, Nexavar, Torisel and Avastin.

Ongoing research

A pivotal Phase III study of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cancer is ongoing. Over 500 patients are included in the study. The primary endpoint is overall survival.

Current results

The ongoing Phase III study is evaluating the effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary clinical efficacy parameter will be read after 384 registered events (deaths), and calculated with respect to overall survival. An updated analysis, conducted during the period, of the number of registered events indicates that it will be possible to present the results 2012, which is later than the earlier forecast. This delay in reading the results is due to a lower number of events registered than previously assumed based on historical data.