OREANDA-NEWS. Merck, a leading science and technology company, will present data at the ESMO 18th World Congress on Gastrointestinal Cancer (WCGC) from the pivotal Phase III TAILOR study in patients from China, the first prospective trial to evaluate an anti-EGFR antibody in the first-line therapy of patients with RAS wild-type metastatic colorectal cancer (mCRC). The results demonstrate that Erbitux® (cetuximab) plus FOLFOX statistically significantly improves outcomes, including progression-free survival (PFS; primary endpoint), overall survival (OS) and best overall response rate (bORR), compared with FOLFOX alone.(1)

Notably, compared with those receiving FOLFOX alone, patients in the study receiving Erbitux plus FOLFOX experienced1:
· a bORR of 61.1% (versus 39.5%; odds ratio [OR]: 2.41; p<0.001), which is in line with international studies
· a 31% decrease in the risk of disease progression (hazard ratio [HR]: 0.69; p=0.004); and,
· a 24% reduction in the risk of death (HR: 0.76; p=0.02).

“As a standard-of-care treatment, Erbitux is a strategic priority product for Merck and our aspiration is that patients have optimal access to this drug worldwide,” said Luciano Rossetti, Global Head of Research & Development in the biopharma business of Merck. “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.”

The TAILOR study randomized 393 patients from China with RAS wild-type mCRC, and the results demonstrate that adding Erbitux to FOLFOX, as a first-line treatment, significantly improves PFS (median PFS: 9.2 vs 7.4 months) and OS (median OS: 20.7 vs 17.8 months). The safety profile of Erbitux observed in TAILOR is similar to that seen in prior randomized clinical trials, with no unexpected safety findings.