publication date: Aug. 4, 2016

Colorectal Cancer Trial: Erbitux-FOLFOX Therapy Improves PFS, OS in RAS Wild-Type Colorectal Cancer

 

Results from a phase III trial of patients with metastatic colorectal cancer demonstrated that Erbitux (cetuximab) plus FOLFOX improved outcomes—including progression-free survival, overall survival and best overall response rate—when compared with FOLFOX alone.

The trial, named TAILOR, evaluated 393 patients in China with RAS wild-type disease, and found a 31 percent decrease in the risk of disease progression (HR: 0.69; p=0.004); and a 24 percent reduction in the risk of death (HR: 0.76; p=0.02). The study also found a best overall response rate of 61.1 percent, compared to 39.5 percent (odds ratio: 2.41; p<0.001), which is in line with international studies, according to Merck, Erbitux’s sponsor.

Adding Erbitux to FOLFOX as a first-line treatment improved median PFS to 9.2 months, compared to 7.4 months, and median OS to 20.7 months, vs 17.8 months. The safety profile of Erbitux observed in TAILOR is similar to that seen in prior randomized clinical trials.

“We are confident the TAILOR results form a good basis upon which approval could be extended to first-line metastatic colorectal cancer treatment in China,” said Luciano Rossetti, executive vice president and global head of Research & Development for the biopharma business of Merck, which plans to present the study data at the European Society of Medical Oncology World … Continue reading CCL July – Trial: Erbitux-FOLFOX Therapy Improves PFS, OS in RAS Wild-Type Colorectal Cancer

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