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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

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Important Notice: The information provided here relates to investigational therapies. The safety and efficacy of these investigational therapies has not been proven.

Presentation

First-line (1L) Encorafenib + Cetuximab + mFOLFOX6 in East Asian Patients with BRAF V600E-mutant Metastatic Colorectal Cancer (mCRC): Results From The Phase 3 BREAKWATER Study

T. Yoshino, T.W. Kim, Y. Yuan, Z. Chen, J. Zhang, Y.-M. Yeh, K. Yamaguchi, Q. Wang, S. Kim, T. Masuishi, M. Shiozawa, C. Inagaki, A. Zhou, T. Usari, K. Olu, Y. Tian, X. Zhang, L. Shen

Encorafenib | December 5, 2025 | ESMO Asia 2025

C4221015 | NCT04607421

Poster

Safety profile associated with first-line (1L) encorafenib plus cetuximab (EC) ± mFOLFOX6 and chemotherapy (chemo) ± bevacizumab (bev) in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) (BREAKWATER)

Van Morris, Elena Elez, Jeanne Tie, Scott Kopetz, Eric Van Cutsem, Harpreet Wasan, Sara Lonardi, Cathy Eng, Takayuki Yoshino, Tae Won Kim, Lin Shen, Zhiyu Chen, Michael J. Raphael, Eduardo Polo Marques, Marieke Vollebergh, Tiziana Usari, Elena Beyzarov, Kelechi Olu, Xiaosong Zhang, Josep Tabernero

Encorafenib | October 19, 2025 | ESMO 2025

C4221015 | NCT04607421

Poster

Subsequent therapies in the phase 3 BREAKWATER study of first-line encorafenib + cetuximab + mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer

Josep Tabernero, Eric Van Cutsem, Cathy Eng, Takayuki Yoshino, Harpreet Wasan, Fortunato Ciardiello, Timothy Maughan, Tae Won Kim, Rona Yaeger, Jayesh Desai, Elena Élez, Sara Lonardi, Lin Shen, Ying Yuan, Van Morris, Tiziana Usari, Katherine Liau, Kelechi Olu, Xiaosong Zhang, Scott Kopetz

Encorafenib | October 19, 2025 | ESMO 2025

C4221015 | NCT04607421

Poster

First-line (1L) encorafenib + cetuximab + mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) in China: results from the phase 3 BREAKWATER study

Xicheng Wang, Ying Yuan, Zhiyu Chen, Jun Zhang, Qi Wang, Xianling Liu, Yongqiang Li, Zuoxing Niu, Xiaoping Qian, Yan Li, Ting Xu, Yihui Zhu, Hui Zhang, Nan Li, Xiaosong Zhang, Lin Shen

Encorafenib | October 17, 2025 | ESMO 2025

C4221015 | NCT04607421

Presentation

BREAKWATER: Analysis of first-line encorafenib + cetuximab + chemotherapy in BRAF V600E-mutant metastatic colorectal cancer

Scott Kopetz, MD, PhD, Takayuki Yoshino, MD, PhD, Eric Van Cutsem, MD, PhD, Cathy Eng, MD, FACP, FASCO, Tae Won Kim, MD, PhD, Harpreet Singh Wasan, MD, Jayesh Desai, FRACP, Fortunato Ciardiello, MD, PhD, Rona Yaeger, MD, Timothy S. Maughan, MD, Elena Beyzarov, PharmD, Xiaoxi Zhang, PhD, Graham Ferrier, PhD, Xiaosong Zhang, MD, PhD, Josep Tabernero, MD, PhD

Encorafenib | January 25, 2025 | ASCO GI 2025

C4221015 | NCT04607421

Presentation

Encorafenib + Cetuximab (EC) + FOLFIRI for BRAF V600E-Mutant Metastatic Colorectal Cancer (mCRC): Updated Results From the BREAKWATER Safety Lead-In (SLI)

Josep Tabernero, Takayuki Yoshino, Tae Won Kim, Rona Yaeger, Jayesh Desai, Harpreet Wasan, Eric Van Cutsem, Fortunato Ciardiello, Tim Maughan, Cathy Eng, Jeanne Tie, Elena Elez, Sara Lonardi, Tiziana Usari, Erik Hahn, Samuel Dychter, Graham Ferrier, Xiaosong Zhang, Scott Kopetz

Encorafenib | September 14, 2024 | ESMO 2024

C4221015 | NCT04607421