New colorectal cancer drug Braftovi will receive reimb

Ono Pharmaceutical held a press conference on 11th, commemorating reimbursement listing of colorectal cancer drug Braftovi in Korea

The combination therapy of Braftovi and cetuximab has shown efficacy and safety as a second-line treatment for colorectal cancer

Braftovi could serve as a 1st-line treatment for BRAF V600E colorectal cancer, which typically shows poor prognosis.

Ono Pharmaceutical Korea held a press conference celebrating reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation.

All eyes are on Braftovi, a new targeted drug for metastatic colorectal cancer emerging after a 15-year gap, for its potential to address unmet demands for treatment options.

 

Experts have assessed that, based on proven efficacy, Braftovi is likely to be highly utilized.

 

On the 11th, Ono Pharmaceutical Korea held a press conference celebrating the reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation.

 

Braftovi is a targeted drug, emerged 15 years after Merck’s Erbitux (cetuximab), for the treatment of colorectal cancer.

 

In Phase 3 BEACON CRC studies, Braftovi has demonstrated efficacy and a safety profile in patients with BRAF V600E mutation who have developed tolerance to previous therapies.

 

Based on clinical results, patients who received the combination therapy of Braftovi and cetuximab demonstrated a median overall survival (OS) of 9.3 months, a significant extension compared to the 5.9 months observed in those treated with the combination therapy of irinotecan and cetuximab.

 

The mortality risk decreased by 39%.

 

The therapy’s benefits were consistently observed, regardless of the patient’s systemic therapy outcomes, the number of previous therapies, tumor metastasis range and location.

 

The group that received the combination therapy of Braftovi and cetuximab has shown 10 times higher overall response rate (ORR) compared to the comparative thearpy group (19.5% in Braftovi combination therapy group vs.

 

1.8% in comparative therapy group).

 

With a three-fold increase in Progression free survival (PFS), the risk of disease progression and death was reduced by 56%.

 

Moreover, the group that received the combination therapy of Braftovi and cetuximab has shown an overall satisfactory safety profile, with a lower rate of severe adverse drug reactions compared to the comparative therapy group.

 

"In the treatment of metastatic colorectal cancer, conventional therapies such as FOLFIRI and FOLFOX, in addition to Erbitux, have been used.

 

However, there were concerns about drug toxicity and side effects.

 

The combination therapy of Braftovi and Erbitux has shown longer treatment duration and a lower treatment discontinuation rate," Cha Yongjun, Professor in the Hematology-Oncology Department at the National Cancer Center, stated.

 

Braftovi may have a role in treating BRAF V600E, which is associated with poor prognosis The BRAF V600E mutation occurs in approximately 4.7% of patients with metastatic colorectal cancer in Korea.

 

Patients carrying this mutation tend to have worse prognosis, such as larger tumor size and peritoneal metastasis, compared to those who do not have the BRAF V600E mutation.

 

In metastatic colorectal cancer patients with BRAF V600E mutation, the OS was 11.4 months, which was less than half of the 43 months for BRAF V600E-negative.

 

The guidelines of the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) have identified the BRAF V600E mutation as a factor associated with poor prognosis in metastatic colorectal cancer, and they recommend BRAF mutation testing for all diagnosed patients.

 

In clinical practices, it is recommended for all metastatic colorectal cancer patients to undergo RAS mutation testing and BRAF mutation testing.

 

As a result, the analysis suggests that Braftovi may have broad clinical utility.

 

“Currently, the available treatment options for colorectal cancer are limited.

 

The therapeutic outcomes for second-line treatments following unsuccessful first-line treatment have been minimal.

 

Nine out of ten patients have failed to proceed to third-line treatments.

 

There is a critical need for new therapeutic options,” Kim Seung Tae, Professor of the Division of Hematology-Oncology at the Samsung Medical Center, commented.

 

Professor Kim analyzed that “BRAF V600E mutated metastatic colorectal cancer is associated with poor prognosis and a significantly high rate of peritoneal metastasis.

 

While the first-line standard treatment typically includes anti-EGFR therapy such as Erbitux, it has been reported that BRAF V600E mutation is less responsive to chemotherapy.

 

Therefore, Braftovi could potentially become a first-line treatment option.”