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.
Notably, compared with those receiving FOLFOX alone, patients in the study receiving Erbitux plus FOLFOX experienced:
- 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, Executive Vice President, 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.
"The results of the TAILOR study further reaffirm that Erbitux plus FOLFOX as chemotherapy backbone is an effective treatment regimen for patients with RAS wild-type mCRC, as we have seen in previous international pivotal studies, such as OPUS," said Prof. Carsten Bokemeyer, University Medical Center,
Hamburg-Eppendorf, Germany and primary investigator of the OPUS study. "As the first prospective trial evaluating Erbitux in RAS wild-type patients, the TAILOR results reinforce the value and importance of RAS biomarker testing in order to determine the appropriate targeted therapy for individual patients, based on their tumor's genetic make-up."
Both the National Comprehensive Cancer Network (U.S.) and the European Society for Medical Oncology clinical guidelines recommend first-line treatment with Erbitux plus either FOLFOX or FOLFIRI for patients with RAS wild-type mCRC.
"There are currently limited first-line options available in China for patients with RAS wild-type metastatic colorectal cancer," said Professor Shukui Qin from Nanjing Bayi Hospital, China, Coordinating Investigator in the TAILOR study. "The results of the TAILOR study strongly support the benefit of Erbitux in the treatment of these patients, and we are hopeful it will soon be approved so that patients in this country will be able to access treatment options that they so desperately need."
Erbitux has obtained marketing authorization in over 90 countries worldwide. In Europe, Erbitux is indicated as first-line therapy for patients with RAS wild-type mCRC tumors, together with the oxaliplatin-containing regimen FOLFOX in treatment-naïve patients or together with regimens containing irinotecan (e.g. FOLFIRI). More than 442,000 patients with mCRC have been treated with Erbitux.