Significant and clinically relevant improvement seen in objective response rate with encorafenib + cetuximab plus mFOLFOX6
By Elana Gotkine HealthDay Reporter
TUESDAY, Feb. 4, 2025 (HealthDay News) — For patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), encorafenib + cetuximab (EC) plus standard chemotherapy (modified folinic acid [or levofolinate], fluorouracil, and oxaliplatin regimen [mFOLFOX6]) is associated with an improved objective response rate compared with standard of care (SOC), according to a study published online Jan. 25 in Nature Medicine. The research was published to coincide with the American Society of Clinical Oncology annual Gastrointestinal Cancers Symposium, held from Jan. 23 to 25 in San Francisco.
Scott Kopetz, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined EC+mFOLFOX6 versus SOC in patients with previously untreated BRAF V600E mCRC in the phase 3 BREAKWATER study.
At data cutoff, data were not mature for the dual primary end point of progression-free survival. However, the researchers found that BREAKWATER met the other dual primary end point of objective response rate, demonstrating a significant and clinically relevant improvement (60.9 versus 40.0 percent for EC+mFOLFOX6 versus SOC; odds ratio, 2.443). The median duration of response was 13.9 and 11.1 months, respectively. The hazard ratio was 0.47 at this first interim analysis of overall survival. The safety profiles were consistent with those known for each agent; serious adverse event rates were 37.7 and 34.6 percent in the EC+mFOLFOX6 and SOC groups, respectively.
“These encouraging data support this regimen to potentially become the new SOC in BRAF V600E-mutant mCRC; prespecified analyses of mature progression-free survival and overall survival data are planned,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Pfizer, which sponsored BREAKWATER; support was also received from other pharmaceutical companies.
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