Note: On 16 October 2012, WILEX announced results of the Phase III ARISER trial with RENCAREX® (INN: Girentuximab) to treat clear cell renal cell carcinoma (ccRCC). The trial did not meet its primary endpoint. The analysis showed no improvement in median DFS (approximately 72 months) following RENCAREX® treatment compared with placebo. RENCAREX® was safe and well tolerated. The Independent Data Monitoring Committee (IDMC) has recommended terminating the Phase III ARISER trial (press release).
|Compound Class||Chimeric monoclonal antibody|
|INN (International Nonproprietary Name)||Girentuximab|
|Indication||Clear cell renal cell cancer (ccRCC) and other solid tumours|
|Target||The Antibody Girentuximab binds specifically to the protein structure carbonic anhydrase IX (also called CA IX, MN or G250 antigen). CA IX is expressed on the cell surface of clear cell renal cell carcinomas but not on healthy renal tissue. The protein is also present in a variety of other solid tumours, e.g. head&neck and colon cancer.
|Mode of Action||ADCC*|
|Development Status||RENCAREX® has completed clinical Phase II trials in combination therapy with cytokines (IL-2 and IFN) in patients with metastatic RCC. Final data of the Phase III ARISER trial for the adjuvant therapy of patients with non-metastatic clear cell RCC at high risk of relapse after surgery were presented at the ASCO in June 2013 (More information).|
|Orphan Drug Status||Orphan Drug Status for the U.S. and the EU in the indication RCC.
|Fast Track Status||Granted by the FDA in October 2011 for the adjuvant setting.
|Partner||Laboratorios del Dr. Esteve S.A.: commercialisation rights for Spain, Italy, Portugal, Andorra and Greece.|
|Development Rationale||Standard therapy for non-metastatic clear cell RCC is resection of the affected kidney and any associated tumour mass followed by observation. At the beginning of the ARISER trial, a high recidivism rate and recurrence rate of 2 to 3 years was assumed. To-date there is no adjuvant treatment approved by the FDA** or EMEA** for patients after surgery.
|History||RENCAREX® is a targeted antibody for the treatment of solid tumours. The G250 antibody was originally developed at the University of Leiden, Netherlands, by a team led by Prof. Sven Warnaar, who joined WILEX in 1999 and served as the Company’s Chief Scientific Officer until he retired in June 2003.|
* Antibody-dependent cellular cytotoxicity („ADCC„) is the mechanism by which antibodies induce natural killer („NK“) cells or other effector cells of the patient’s immune system to destroy tumour cells.
** FDA: Food and Drug Administration, EMEA: European Medicines Evaluations Agency