Merck has reported that the Chinese Phase III TAILOR study has demonstrated positive results of Erbitux (cetuximab) plus Folfox chemotherapy, compared with Folfox alone in patients with RAS wild-type metastatic colorectal cancer (mCRC).
The company stated that the Phase III trial met its primary endpoint of significantly increasing progression-free survival (PFS) in patients with RAS wild-type mCRC treated with Erbitux (cetuximab) plus Folfox chemotherapy, compared with Folfox alone.
Secondary endpoints of the trial include overall survival, best overall response rate, time to treatment failure and rate of curative surgery for liver metastases.
During the trial, all randomised subjects were scheduled to receive treatment until the occurrence of progressive disease (PD) or unacceptable toxicity.
The open-label, randomised, controlled, multi-centre trial enrolled 397 patients with RAS wild-type mCRC.
Following the positive response of the trial, Merck is planning to work with relevant authorities to make Erbitux available for patients in China as a first-line treatment for RAS wild-type mCRC patients.
Merck also noted that the clinical benefit that Erbitux provides to RAS wild-type mCRC patients is further reinforced by the secondary endpoint results, which support the superiority shown for PFS.
The safety profile of Erbitux in the TAILOR clinical trial was manageable and similar to that observed in other major trials, with no surprising safety findings.
Both the National Comprehensive Cancer Network in the US and the European Society for Medical Oncology clinical guidelines advocate first-line treatment with Erbitux plus Folfox or Folfiri for patients with RAS wild-type mCRC.
TAILOR study coordinating investigator Shukui Qin said: "We are excited that the TAILOR study is positive and that Erbitux in combination with chemotherapy could become a new first-line treatment option for metastatic colorectal cancer patients in China, once approved.
"It is also reassuring that the results reflect those previously observed, and support the indicated first-line use of Erbitux plus FOLFOX in many countries."
So far, Erbitux has received marketing authorisation in more than 90 countries across the globe.
In Europe, Erbitux is considered as first-line therapy for patients with RAS wild-type mCRC tumours, together with the oxaliplatin-containing regimen Folfox in treatment-naïve patients or with regimens containing irinotecan.
More than 442,000 patients with mCRC have been treated with Erbitux, a IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).