FDA approves Pfizer/Merck KGaA combo in advanced colorectal cancer

The FDA has approved a combination of Pfizer’s Braftovi and Merck KGaA’s Erbitux for a form of untreated metastatic colorectal cancer, the first targeted drug regimen for this form of the disease.

Braftovi (encorafenib) and Erbitux (cetuximab) have been approved in combination for adults with metastatic colorectal cancer (CRC) with a BRAFV600E mutation as detected by an FDA-approved test after previous therapy.

Approval is based on results from the BEACON CRC trial, the only phase 3 trial to study patients with previously treated CRC with the mutation, Pfizer said in a statement.

The plan now is to investigate whether Braftovi could be used earlier in patients with earlier stage disease.

BRAF mutations occur in up to 15% of people with metastatic colorectal cancer and are associated with a poor prognosis.

Results from BEACON CRC showed those taking the Braftovi combination had a median overall survival of 8.4 months, compared with 5.4 months in a control group treated with Erbitux and either irinotecan or FOLFIRI chemotherapy.

Results showed an improved objective response rate of 20% in the Braftovi group compared with 2% in the control group.

Median progression-free survival was 4.2 months in the treatment arm, compared with 1.5 months in the control arm.

A total of 220 patients were randomised to the Braftovi/cetuximab arm and 221 to the control arm.

The primary goal was overall survival, with additional efficacy outcome measures including progression-free survival, overall response rate and duration of response as assessed by blinded independent central review.

The trial was conducted at over 200 investigational sites in North America, South America, Europe and the Asia Pacific region.

It was conducted with support from Ono Pharmaceutical, Pierre Fabre and Merck KGaA at sites outside the US.

Scott Kopetz, associate professor of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center, said:  “As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, Braftovi in combination with cetuximab is a much-needed new treatment option for these patients.”