Pharmaceutical Business review

Drug combination study disappoints Genentech

The analysis of the data suggested that the combination of the two drugs was no more effective in treating the disease than the use of Avastin on its own. The trial measured two primary efficacy endpoints, progression-free survival, and response rate.

The company said that due to the exploratory nature of the study, these data do not provide definitive conclusions with high statistical certainty with respect to differences between the treatments. However, the company seems to have seen enough to stop the trial.

“At this time we do not believe further studies of this particular combination in kidney cancer are warranted. However, we remain encouraged by the duration of progression-free survival seen in patients treated with Avastin both in this trial and in previous studies in kidney cancer,” said Dr Hal Barron, Genentech senior vice president, development and chief medical officer.

A preliminary assessment of safety showed that adverse events in this study were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, and included diarrhea, rash, nausea/vomiting, hypertension, bleeding, proteinuria and pruritus.