Ono Pharmaceutical Korea said Thursday that Braftovi (encorafenib), a targeted therapy for BRAF V600E-mutated metastatic colorectal cancer, has been approved for health insurance coverage effective Jan. 1.
The reimbursement will be available in combination with cetuximab for patients with metastatic colorectal cancer who have received prior therapy and have a confirmed BRAF V600E mutation.
Colorectal cancer experts said this coverage will expand the opportunities for Braftovi to treat patients with BRAF V600E mutations.
According to Kim Seung-tae, Professor of Hemato-Oncology at Samsung Medical Center, the BRAF V600E mutations are found in 4.7 percent of metastatic colorectal cancer patients in Korea. Patients with this mutation have a worse prognosis than BRAF V600E-negative patients, as their tumors increase in size and develop peritoneal metastases.
"Patients with BRAF V600E-mutated metastatic colorectal cancer tend to progress up to twice as fast as other colorectal cancer patients after first-line treatment," said Kim. "Historically, follow-up treatment after first-line treatment failure has been ineffective, and nine out of 10 patients do not receive third-line treatment, demanding a need for new therapeutic alternatives for these patients."
Results from the phase 3 study of 665 patients with BRAF V600E-mutated metastatic colorectal cancer showed a median overall survival (mOS) of 9.3 months for the Braftovi and cetuximab combo arm, compared to 5.9 months for the control irinotecan plus cetuximab arm.
Cha Yong-jun, Professor of Hemato-Oncology at the National Cancer Center, said that the Braftovi and cetuximab combination showed a notable benefit over the control group in the primary endpoint, including OS.
"The combination of Braftovi and cetuximab as second-line treatment provides greater survival benefit than third-line treatment, allowing more than 60 percent of patients to proceed to follow-up treatment even if their disease progresses," said Cha.
"With the inclusion of Braftovi in insurance coverage, patients will have access to the latest treatment regimens," Cha went on to say.
"Braftovi is the first targeted therapy to fill the unmet need for patients with BRAF V600E-mutated metastatic colorectal cancer," said Choi Ho-jin, President of Ono Pharmaceutical Korea. "We will do our best to expand treatment opportunities for patients in Korea with the reimbursement."