169P - First-line FOLFOX-4 ± cetuximab in patients with RAS wild-type metastatic colorectal cancer: The open-label, randomized, phase 3 TAILOR trial

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Biomarkers
Colon Cancer
Rectal Cancer
Presenter Shukui Qin
Citation Annals of Oncology (2016) 27 (suppl_9): ix53-ix67. 10.1093/annonc/mdw581
Authors S. Qin1, J. Xu2, L. Wang3, Y. Cheng4, T. Liu5, J. Chen6, J. Liu7, J. Li8
  • 1Department Of Oncology, Nanjing Bayi Hospital, 210000 - Nanjing/CN
  • 2Department Of Oncology, 307 Hospital of PLA, 100000 - Beijing/CN
  • 3Department Of Oncology, Shanghai's First People's Hospital, No. 85, 200080 - Shanghai/CN
  • 4Department Of Oncology, Jilin Cancer Hospital, 130012 - Changchun/CN
  • 5Department Of Oncology, Zhongshan Hospital affiliated to Fudan University, 200032 - Shanghai/CN
  • 6Global Clinical Development, Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd, 200070 - Shanghai/CN
  • 7Biostatistics, Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd, 200070 - Shanghai/CN
  • 8Department Of Oncology, Tongji University Shanghai East Hospital, 20000 - Shanghai/CN

Abstract

Background

Cetuximab in combination with chemotherapy (FOLFIRI or FOLFOX) is a standard-of-care first-line treatment for patients (pts) with RAS wild-type (wt) metastatic colorectal cancer (mCRC). However, there have been questions about the combination with FOLFOX as a standard-of-care first-line treatment for pts with KRAS wt mCRC due to limited available data. The purpose of the randomized, phase 3 TAILOR trial is to confirm the efficacy and safety of FOLFOX-4 + cetuximab vs FOLFOX-4 in the first-line treatment of pts from China with RAS wt mCRC.

Methods

TAILOR (EMR62202-057; NCT01228734) is an open-label, randomized, multicenter, phase 3 trial that includes a modified intention-to-treat (mITT) population of 393 pts from China with RAS wt mCRC treated with FOLFOX-4 ± cetuximab. The primary endpoint of TAILOR is progression-free survival (PFS) time as assessed by an independent review committee (IRC) according to RECIST 1.0; key secondary endpoints include overall survival (OS) time, overall response rate (ORR), and safety/tolerability.

Results

In the mITT population, 193 pts with RAS wt mCRC were randomized to FOLFOX-4 + cetuximab and 200 pts to FOLFOX-4. Baseline characteristics were reasonably balanced between the 2 treatment arms. Adding cetuximab to FOLFOX-4 significantly improved the primary endpoint of PFS by IRC, with an HR [95% CI] of 0.69 [0.54-0.89] (p = .004; median PFS time, 9.2 vs 7.4 months). The key secondary endpoints of ORR (61.1% vs 39.5%; odds ratio [95% CI] = 2.41 [1.61-3.61]; p < .001) and current assessment of OS (HR [95% CI] = 0.76 [0.61-0.96]; p = .020; median OS time, 20.7 vs 17.8 months) also confirmed clinical benefit from the addition of cetuximab to FOLFOX-4. There were no new or unexpected safety findings.

Conclusions

The addition of cetuximab to first-line FOLFOX chemotherapy statistically significantly improved PFS, OS, and ORR in pts from China with RAS wt mCRC, an observation that is consistent with previous pivotal studies. The TAILOR study met its primary objective and confirms cetuximab in combination with chemotherapy as a standard-of-care first-line treatment regimen for pts with RAS wt mCRC.

Clinical trial indentification

NCT01228734 EMR62202-057

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

J. Chen, J. Liu: Employee of Merck Serono Co., Ltd., Beijing, China. J. Li: Received research funding from Merck and Roche. All other authors have declared no conflicts of interest.