FDA Approves First Targeted Therapy for BRAF V600E-Mutant Metastatic Colorectal Cancer

From Jike Pharmaceutical News

On April 9, Pfizer announced that the U.S. FDA had approved Braftovi^®(encorafenib) in combination with cetuximab (brand name Erbitux^®) for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring a BRAF V600E mutation (detected by an FDA-approved test) who have received prior therapy. This regimen is the first and only FDA-approved targeted therapy specifically indicated for adult patients with previously treated, BRAF V600E-mutant metastatic colorectal cancer (CRC). The FDA had granted encorafenib Priority Review and Breakthrough Therapy designation. This approval was based on the results of the BEACON CRC trial, which is the only Phase 3 clinical trial specifically studying patients with previously treated, BRAF V600E-mutant metastatic colorectal cancer (CRC).

Based on the results of the BEACON CRC trial, Braftovi in combination with cetuximab demonstrated a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0), compared to 5.4 months (95% CI: 4.8, 6.6) in the control group (irinotecan plus cetuximab or FOLFIRI plus cetuximab) [HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]. Furthermore, the objective response rate (ORR) was 20% (95% CI: 13%, 29%) for Braftovi plus cetuximab versus 2% (95% CI: 0%, 7%) for the control group (p<0.0001), and the median progression-free survival (mPFS) was 4.2 months (95% CI: 3.7, 5.4) versus 1.5 months (95% CI: 1.4, 1.7) in the control group [HR 0.40, (95% CI: 0.31, 0.52), p<0.0001].

“We are pleased with the FDA approval of Braftovi in combination with cetuximab, as we are committed to developing targeted therapies that can help patients with certain mutation-driven cancers. We thank the patients and investigators who participated in the Phase 3 BEACON CRC trial. We are proud to now be able to offer a targeted treatment option for patients with previously treated BRAF V600E-mutant metastatic colorectal cancer (CRC). Looking ahead, we are dedicated to continuing to study this treatment regimen in earlier lines of therapy,” said Dr. Chris Boshoff, Chief Development Officer, Oncology, Global Product Development at Pfizer.

Scott Kopetz, Associate Professor of Oncology at The University of Texas MD Anderson Cancer Center, stated, “It is estimated that up to 15% of patients with metastatic colorectal cancer harbor BRAF gene mutations, and these patients have a poorer prognosis. As the first and only targeted therapy regimen for patients with previously treated BRAF V600E-mutated metastatic CRC, the combination of Braftovi and cetuximab represents a much-needed new treatment option for these patients.”

Globally, colorectal cancer is the third most common cancer type in men and the second most common in women. In the United States alone, there were approximately 1.8 million new diagnoses in 2018. It is estimated that 147,950 people will be diagnosed with colon or rectal cancer in 2020, and approximately 53,000 people die from this disease annually. Up to 15% of patients with metastatic colorectal cancer (CRC) are estimated to harbor BRAF mutations, which are associated with a poor prognosis in these patients. The BRAF V600E mutation is the most common BRAF mutation, and CRC patients carrying this mutation have more than twice the risk of death compared to those with wild-type BRAF.

References:

[1] U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy. Retrieved 2020-04-09, from https://finance.yahoo.com/news/u-fda-approves-braftovi-encorafenib-222700950.html?from=groupmessage&guccounter=1

Original Title: Express | FDA Approves First Therapy Targeting BRAF V600E Mutation for Metastatic Colorectal Cancer

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