Results of Phase III TAILOR study shows Erbitux (cetuximab) plus FOLFOX chemotherapy met primary endpoint in colorectal cancer- Merck

Merck has announced that the pivotal Chinese Phase III TAILOR study met its primary endpoint of significantly increasing progression-free survival (PFS) in patients with RAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux (cetuximab) plus FOLFOX chemotherapy, compared with FOLFOX alone.

The TAILOR study is a Phase III, open-label, randomized, controlled, multicenter trial designed to compare Erbitux in combination with FOLFOX-4 versus FOLFOX-4 alone in the first-line treatment of Chinese patients with RAS wild-type mCRC. All randomized subjects were planned to receive treatment until the occurrence of progressive disease (PD) or unacceptable toxicity. The study enrolled 397 patients with RAS wild-type mCRC. The primary endpoint of the trial is progression-free survival. Secondary endpoints include: overall survival, best overall response rate, time to treatment failure and rate of curative surgery for liver metastases.

The clinical benefit that Erbitux offers to RAS wild-type mCRC patients is further strengthened 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 pivotal trials, with no unexpected safety findings. The full study results will be submitted to upcoming international scientific meetings.

Comment: 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).