Advertisement


Elena Elez, MD, PhD, on Updated Survival Data From the BREAKWATER Trial

2025 ASCO Annual Meeting

Advertisement

Elena Elez, MD, PhD, of Vall d’Hebron Institute of Oncology, presents updated overall survival data as well as progression-free survival data from the BREAKWATER trial of the first-line use of encorafenib, cetuximab, and mFOLFOX6 in BRAF V600E–mutant metastatic colorectal cancer (LBA3500). 



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
We know that between 8 to 12% of patients with metastatic colorectal cancer have BRAF V600E–mutated metastatic colorectal cancer. What we know from these illnesses is that it's a poor prognosis group of patients, so the first-line treatments that we have have really limited efficacy, and this was the basis for developing a phase three clinical trial in this patient population. We know as well that encorafenib is an ATP-competitive BRAF inhibitor that, combined with cetuximab, was approved for treatment in the second and third line of metastatic colorectal cancer in this patient population. What we are doing now is exploring the combination of encorafenib, cetuximab, and FOLFOX in frontline therapy for this patient population, compared to encorafenib and cetuximab alone or the standard of care, which is chemotherapy combined with bevacizumab or not. The dual primary endpoint of this clinical trial was progression-free survival and overall response rate, and the secondary objective of this clinical trial was overall survival. Indeed, the results of the BREAKWATER trial were presented at the beginning of 2025. We had the results of overall response rate—the study met one of its primary endpoints—and what we are presenting now at ASCO 2025 are the results of progression-free survival, the other dual primary endpoint, and results on overall survival. Regarding the patient population, it was well balanced. It's nice to see that we have a representation of patients with high tumor burden, meaning three or more metastatic sites of metastasis as well as liver metastasis. Regarding the results on overall survival, the combination of FOLFOX, encorafenib, and cetuximab was statistically significant and clinically meaningful, superior compared to the standard of care. In this case, we found 30 months of overall survival for the patients treated with encorafenib, cetuximab, and FOLFOX, and 15 months for those patients treated with the standard of care. This represents a paradigm change in the treatment of metastatic colorectal cancer harboring a BRAF V600E mutation, and this regimen will be a new standard of care in the frontline setting for this patient population.

Related Videos

Lung Cancer

David R. Spigel, MD, FASCO, on NSCLC Treatment Planning: Role of 14-Gene Molecular Assay

David R. Spigel, MD, FASCO, Chief Scientific Officer of Sarah Cannon Research Institute, reviews data on the role of a 14-gene molecular assay in selecting patients with stage IA–IIA non–small cell lung cancer (NSCLC) as high risk (LBA8027). 

Breast Cancer
Issues in Oncology

Neil M. Iyengar, MD, on Cancer Risk Reduction: Effects of Menopausal HRT and GLP-1 RAs

Neil M. Iyengar, MD, of Memorial Sloan Kettering Cancer Center, reviews several studies that aimed to answer two questions: does menopausal hormone therapy (HRT) impact overall survival and breast cancer–specific mortality in younger women diagnosed with high-risk disease (Abstract 10506); and do GLP-1 receptor agonists (GLP-1 RAs), a class of weight-loss medications, have cancer risk reduction properties (Abstracts 10507 and 10508). 

Hematologic Malignancies

Andrew Kuykendall, MD, on Hepcidin Mimetic for Polycythemia Vera

Andrew Kuykendall, MD, of Moffitt Cancer Center, discusses findings from the phase III VERIFY trial, which compared the efficacy of rusfertide vs placebo in patients with polycythemia vera who continue their current standard of care therapy (Abstract LBA3). 

Lung Cancer

Martin Reck, MD, PhD, on Postsurgical MRD, Genomic Mutations, and Outcomes in Resectable NSCLC: AEGEAN Trial

Martin Reck, MD, PhD, of LungenClinic Grosshansdorf, Germany, discusses data from the phase III AEGEAN trial that studied perioperative durvalumab and neoadjuvant chemotherapy. Patients who were MRD-positive after surgery had significantly worse disease-free survival compared to MRD-negative patients. In addition, mutations in KEAP1 and KMT2C were associated with MRD positivity and reduced benefit from the regimen, identifying a small high-risk subgroup with poor prognosis (Abstract 8009). 

Prostate Cancer

Gerhardt Attard, MD, PhD, on a Novel Regimen for Metastatic Castration-Sensitive Prostate Cancer With HRR Alterations

Gerhardt Attard, MD, PhD, of the Cancer Institute, University College London, presents findings from the phase III AMPLITUDE trial, which looked at the combination of niraparib and abiraterone acetate plus prednisone for patients with metastatic castration-sensitive prostate cancer with alterations in homologous recombination repair (HRR) genes (Abstract LBA5006). 

Advertisement

Advertisement




Advertisement