ROCHE SUSPENDS ENROLLMENT INTO TRIAL OF C.E.R.A.

Roche announced it is temporarily suspending recruitment into its Phase II dose-finding study using its investigational drug C.E.R.A. in anaemic patients with advanced non-small-cell lung cancer (NSCLC) receiving chemotherapy. An independent drug safety monitoring board (DSMB) recommended this course of action. 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 NSCLC in 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 hemoglobin levels or the administered doses based on the current review of the data, Roche said.

Roche has not observed a similar type of imbalance in previously completed studies of 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 such as the severity of tumor spread, presence of liver metastases and incidence of chronic obstructive pulmonary disease. A total of 153 patients have been randomized in the study. Roche and the DSMB will closely monitor the safety data from the patients continuing in the study.