Pfizer has released results from the interim analysis of the Phase 3 BEACON CRC trial, to evaluate the combination of BRAFTOVI (encorafenib), MEKTOVI (binimetinib), and cetuximab (BRAFTOVI Triplet).

The study is intended to evaluate the Triplet combination in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), after one or two lines of therapy.

Pfizer global product development oncology 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.”

Phase3 BEACON CRC Trial results showed improved secondary efficacy endpoints

The results showed significant improvements in overall survival (OS) and objective response rates (ORR) for the BRAFTOVI Triplet and BRAFTOVI Doublet (BRAFTOVI and cetuximab) combination, compared to cetuximab plus irinotecan-containing regimens as control.

Pfizer said that the BRAFTOVI Triplet showed a median OS of 9.0 months, compared to 5.4 months for control, in addition to a significantly improved ORR of 26% compared to 2% for control, and the BRAFTOVI Doublet showed a significant improvement in OS compared to control.

In addition, the data offered details on the primary and secondary endpoints, including a descriptive analysis of OS comparing the BRAFTOVI Triplet to the BRAFTOVI Doublet.

The BRAFTOVI Triplet and Doublet were well-tolerated with no unexpected toxicities, while the BRAFTOVI Triplet showed 58%, Doublet showed 50% and Control showed 61% Grade 3 or higher adverse events (AEs) in patients.

The company intends to present the data in the oral session at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and publish in The New England Journal of Medicine.

Pfizer said that the treatment is investigational and not approved by the FDA, and would submit the BEACON CRC trial results to obtain marketing approval in the US in the fourth quarter of 2019.

University of Texas MD Anderson cancer centre gastrointestinal medical oncology associate professor Scott Kopetz said: “The BEACON CRC trial results show meaningful improvements compared to an available standard of care for patients with BRAFV600E-mutant mCRC.

“These data presented at ESMO and published in The NEJM further support the potential of the BRAFTOVI Triplet to be the first chemotherapy-free, targeted regimen for this patient population, who have a poor prognosis and limited treatment options.”