Merck’s colorectal cancer drug meets primary endpoint in Phase III study
Merck (FWB: MRK) has announced that its Phase III clinical trial of Erbitux, in combination with Folfox, met its primary endpoint of increased progression-free survival in first line treatment of patients with RAS wild-type metastatic colorectal cancer.
The trial, which took place in China, is set to lead to Merck seeking approval for Erbitux in the Chinese market as a first-line treatment as soon as possible.
The TAILOR study enrolled 397 patients with RAS wild-type metastatic colorectal cancer. It examined Erbitux in combination with Folfox-4 and examined it versus Folfox-4 alone in the first-line treatment of Chinese patients with the disease. As well as meeting its primary endpoint, Erbitux also met the secondary endpoints of overall survival, best overall response rate, time to treatment failure and rate of curative surgery for liver metastases.
Luciano Rossetti, head of global R&D at Marck’s biopharma business, says: “We are thrilled with the TAILOR results that bring a major contribution to the available scientific evidence of Erbitux’s efficacy in combination with Folfox as a standard first-line treatment… These impressive results reinforce the value and imperative of RAS biomarker testing in clinical practice, so as to provide patients with the right targeted therapy.”
Despite being granted marketing authorisation in over 90 countries worldwide, Erbitux was recently not recommended by NICE for treatment on the NHS in England. At the time, Elisabeth Prchla, general manager, Merck in the UK and Ireland, said: “We are disappointed with the preliminary NICE recommendation which in our opinion brings into question the methodology used to assess personalised medicines in patients with metastatic cancer.”
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