Date: 2012-10-16
Type of information:
phase: 3
Announcement: results
Company: Wilex (Germany)
Product: Rencarex®
Action
mechanism: Rencarex® is based on the antibody girentuximab, which binds to the tumour-specific antigen CA IX – an antigen that is overexpressed in clear cell renal cell carcinomas. The therapeutic antibody makes the tumour visible to the endogenous immune system, recruiting natural killer cells which can destroy any existing cancer cells.
Rencarex® should inhibit the further growth and recurrence of clear cell renal cell carcinomas a particularly aggressive type of cancer and kill cancer cells, thereby prolonging the disease-free survival of patients.
Disease: clear cell renal cell carcinoma (ccRCC)
Therapeutic area: Cancer - Oncology
Country:
Trial details: ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal cell carcinoma) is an international, multicentre, randomised trial that examines the efficacy of the antibody Rencarex® in comparison to placebo in the treatment of clear cell renal cell cancer patients following complete or partial surgical removal of the affected kidney in patients with no detectable metastases. The Phase III ARISER trial involves 864 patients, who received the study medication in once-weekly infusions over a period of 24 weeks. The last patient completed treatment in February 2009. Following the occurrence of the 100th relapse, the first interim analysis for futility was carried out in late 2007. The IDMC recommended that the trial be continued because it will probably deliver a significant result. No drug has been approved to date by the FDA or EMA for the adjuvant therapy of non-metastatic clear cell renal cell carcinoma.
Latest
news: * On October 16, 2012, Wilex has announced results of the Phase III ARISER trial with Rencarex® (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.* On February 27, 2012, Wilex has announced that the FDA approved the protocol amendment for the pivotal Phase III ARISER trial with Rencarex® needed to cancel the interim analysis and perform the final analysis of disease free survival (DFS). Final DFS analysis and results are expected in Q4 2012; the study will continue as planned in order to assess overall survivalAs announced in November 2011 the ARISER Independent Data Monitoring Committee had recommended cancelling the interim DFS analysis and performing the final DFS analysis instead. This recommendation was consistent with advice from the FDA and European regulatory authorities.* On January 24, 2011, Wilex has announced the achievement of a major clinical milestone. Over 340 recurrences have now been reported to Wilex by the local sites. Therefore the process for the interim analysis of efficacy in the Phase III registration trial with the drug candidate Rencarex® in the indication renal cancer has now been started. The process involves the central analysis of the data from all 864 patients by independent radiologists. The interim analysis will be carried out by an Independent Data Monitoring Committee (IDMC) and should provide definitive information regarding the endpoint of the trial relevant for approval, namely “disease-free survival”. The results of the interim analysis of efficacy are expected to be available in about six months.
