Merck reports positive pivotal Phase III TAILOR study results of Erbitux and FOLFOX combination for mCRC

3rd July 2016 (Last Updated July 3rd, 2016 18:30)

Merck has reported a positive outcome of pivotal Phase III TAILOR study of the combination of Erbitux (cetuximab) and FOLFOX to treat RAS wild-type, metastatic colorectal cancer (mCRC).

Merck has reported a positive outcome of pivotal Phase III TAILOR study of the combination of Erbitux (cetuximab) and FOLFOX to treat RAS wild-type, metastatic colorectal cancer (mCRC).

Erbitux is an active IG1 monoclonal, antibody targeting, epidermal growth factor receptor (EGFR).

A total of 397 patients were involved in the prospective, open-label, randomised, controlled, multicentre TAILOR trial, which compared Erbitux in combination with FOLFOX-4 versus FOLFOX-4 alone in the first-line treatment China, to address RAS wild-type mCRC.

The trial was focused on determining the progression-free survival, overall survival (OS) and the best overall response rate (bORR), as well as time taken to adjudge a treatment failure and rate of curative surgery for liver metastases.

"The study has exhibited improved outcomes against the disease along with PFS, OS and boRR of the combination of Erbitux and FOLFOX when compared with FOLFOX alone."

University Medical Centre professor and OPUS study primary investigator Carsten Bokemeyer said: "The results of the TAILOR study further reaffirm that Erbitux, along with 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.

"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 tumour's genetic make-up."

The study has exhibited improved outcomes against the disease along with PFS, OS and boRR of the combination of Erbitux and FOLFOX when compared with FOLFOX alone.

Erbitux specifically targets and binds with the EGFR, which blocks the action of the receptor and the subsequent signal-transduction pathway, hence minimising both the invasion of normal tissues by tumour cells and the spread of tumours.