Roche announced today that it is temporarily suspending recruitment into its Phase II dose-finding study (NH19960) with the investigational drug C.E.R.A. in anaemic patients with advanced non small cell lung cancer receiving chemotherapy. An independent Drug Safety Monitoring Board (DSMB) involved in the study recommended this course of action which Roche's Drug Safety Committee endorsed yesterday. Treatment of enrolled patients will continue.

This action has been taken because of a numerical imbalance in the number of deaths across the four arms of the study (three arms with C.E.R.A. and one arm with darbepoetin alfa) driven in part by deaths reported to be due to the progression of the underlying cancer (Stage IIIb and IV Non Small Cell Lung Cancer patients receiving first line chemotherapy).

The investigators reported all deaths to be unrelated to the study drugs. There appears to be no association of these events to excessive haemoglobin (Hb) levels or the administered doses based on the current review of the data.

Roche has not observed a similar type of imbalance in previously completed studies (one phase I/II and two phase II studies) with C.E.R.A. in cancer patients receiving chemotherapy. In another ongoing Clinical Pharmacology Study for lung cancer in Japan, there have been no reported deaths during the scheduled clinical trial period.

A review of the patient data also shows that there were imbalances upon entry into the trial between the different arms in categories like the severity of tumour spread, presence of liver metastases and incidence of chronic obstructive pulmonary disease (COPD).

153 patients have been randomized on the study. Patients who are already enrolled will continue with the study as planned. The safety data from the patients continuing in the study will be closely monitored by Roche working with the DSMB. Roche is further investigating the potential causes for the imbalance across the arms in this population of severely ill patients with advanced and rapidly progressing disease who were enrolled in the study.

Suspending recruitment and allowing currently enrolled patients to complete the 12-week study period will permit an in-depth analysis of the data to determine potential confounding factors and potentially allow recruitment to be restarted.

Roche has informed all investigators involved in the study of its decision and is working closely with them. The company has also informed Health Authorities in the countries where the study is taking place. Roche is committed to patient safety and to the development of innovative medicines that meet unmet medical needs.

About the study

This is a multicenter, randomized, open label dose finding study of C.E.R.A. in anaemic patients with stage IIIB or IV non-small cell lung cancer receiving first line chemotherapy.

This study is assessing the optimal starting dose of C.E.R.A. in the treatment of anaemia in patients with non-small cell lung cancer receiving first line chemotherapy. Patients are randomized to receive C.E.R.A. 6.3µg/kg, 9µg/kg or 12µg/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75µg/kg s.c. every 3 weeks, or 2.25µg/kg every week). Please go to the Roche Clinical Trial Registry at roche-trials/patient/trials/trial110602.html for further information.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at roche.

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