Serono reports clinical trial for targeted cancer drug

Serono and its development partner, Micromet, have released the results of two phase II clinical trials for adecatumumab, a new treatment targeted at specific tumour types.

Adecatumumab, a monoclonal antibody, works by targeting tumour cells “overexpressing” the epithelial cell adhesion molecule (EpCAM). It was tested in a phase II trial for metastatic breast cancer and one for the relapse of prostate cancer.

Although the drug failed to meet the primary endpoints for either trial, Serono claims that much important secondary data was obtained that if confirmed in further trials, could form the basis for a new therapy for patients with tumours displaying a high EpCAM factor.

In particular, metastatic breast cancer patients experienced an increased survival time through using adecatumumab in higher doses. Progression-free survival time in the high dosage groups reached 336 days for one in ten patients, 128 days for a quarter of patients, and 49 days for half. Additionally, a trend towards patients with high EpCAM expression was observed.

Results for the prostate cancer trial indicated that adecatumumab use had a “beneficial” effect in reducing prostate-specific antigen levels in comparison to the placebo in patients with over expression of EpCAM.

Speaking about the breast cancer study, Dr Ahmed Awada, head of the medical oncology unit at the Institute Jules Bordet in Brussels, said: “This finding is important because normally this patient population is believed to have a reduced overall survival compared to patients with low or no EpCAM expression”.

Professor Axel Heidenreich, head of the urological clinic at the University Hospital of Cologne, added that although the prostate cancer study failed to meet its primary endpoint goals, the data obtained “further validates” adecatumumab’s status as a “true targeted therapy”.