Colorectal carcinoma showing lymph node metastasis. Credit: Nephron.

Pfizer has reported positive data from the interim analysis of the Phase III BEACON CRC clinical study conducted to assess Braftovi (encorafenib), Mektovi (binimetinib) and Braftovi Triplet (cetuximab) in metastatic colorectal cancer (mCRC).

The trial involved advanced BRAFV600E-mutant mCRC patients after one or two previous lines of therapy.

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Pfizer presented the data at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, as well as published online in The New England Journal of Medicine (NEJM).

Braftovi is a BRAF inhibitor, while Mektovi is an anti-EGFR antibody. The trial saw the triple combination therapy compared to cetuximab plus irinotecan-containing regimens (control).

Data showed that both primary endpoints of the trial have been met, demonstrating statistically significant improvement in confirmed objective response rate (ORR) and overall survival (OS).

Interim analysis of OS was conducted in all 665 patients. Median OS was nine months and 5.4 months in the control regimen group.

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Secondary endpoint analysis found that subjects on Braftovi and cetuximab combination had a statistically significant improvement of 20.4% in ORR and median OS of 8.4 months.

The figures were 1.9% ORR and 5.4 months median OS in the control arm.

Pfizer Global Product Development chief development officer Chris Boshoff said: “We are pleased to share these data from the BEACON CRC trial with the oncology community.

“With no approved therapies currently indicated specifically for BRAF-mutant mCRC, we believe that the evidence so far shows encouraging potential for the BRAFTOVI Triplet to make a meaningful impact on the lives of those living with this disease.”

Both the Braftovi triplet and doublet were generally well-tolerated without any unexpected toxicities. The safety profiles of these regimens were reported to be consistent with previous data of each regimen and with MEK, BRAF and EGFR therapy effects.