German drugs and chemicals group Merck said on Monday two studies had shown its key colorectal cancer drug Erbitux is safe and reasonably effective in combination with standard chemotherapies.
Merck said data from one of the trials, a mid-stage or Phase II study, showed that Erbitux was safe and effective when combined with the standard first-line treatment of oxaliplatin, folinic acid and 5-fluorouracil, known as the FOLFOX-4 regimen.
Of 42 patients evaluated in the trial, 81 percent had a response, disease was controlled in 98 percent and disease showed progression in only one patient, Merck said.
A separate Phase I/II trial studied Erbitux in combination with another first-line regimen called FUFOX and consisting of folinic acid, 5-fluorouracil and weekly oxaliplatin.
It found that the overall response rate was 55 percent, with one patient out of 38 evaluated showing a complete response and 20 patients showing a partial response, and the disease stable in nine patients. Eight patients did not respond to the drug.
A complete response means that there was no further sign of the disease and a partial response means some shrinkage in tumours.
The trial results are being presented at a European Society for Medical Oncology meeting in Vienna.
Erbitux, licensed from ImClone Systems, is vital for Merck, which faces generic competition for its anti-diabetes drug Glucophage and has experienced setbacks to its research pipeline.