Array BioPharma’s updated results from triplet combination test underscore the potential for patients with BRAF-mutant mCRC

Array BioPharma’s updated results from the Phase 3 BEACON CRC trial evaluating the triplet combination of BRAFTOVI (encorafenib), a BRAF inhibitor, MEKTOVI (binimetinib), a MEK inhibitor and ERBITUX (cetuximab), an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), was generally well-tolerated with no unexpected toxicities.

According to the Array BioPharma’s press release on Monday, the results showed that mature median OS was 15.3 months (95% CI, 9.6–not reached) for patients treated with the triplet.

Axel Grothey, BEACON CRC trial lead investigator, said: “The mature median overall survival of 15.3 months demonstrated in the safety lead-in of the BEACON CRC trial is unprecedented in this patient population and, for context, represents a substantial improvement compared to the observed historical published benchmarks of approximately 4 to 6 months for median overall survival with current standards of care in patients with BRAF-mutant mCRC. These updated data further underscore the potential of this triplet for patients with BRAF-mutant mCRC who are in desperate need of effective new treatment options.”

The company said that the most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased aspartate aminotransferase (10%) and urinary tract infections (10%). The rate of grade 3 or 4 skin toxicities continued to be lower than generally observed with ERBITUX in mCRC.

Victor Sandor, Chief Medical Officer of Array BioPharma, said that the company started an amendment to the BEACON CRC protocol after consulting US FDA and  European EMA to allow for an interim analysis based primarily on confirmed ORR and durability of response endpoints. Sandors said it could support an accelerated approval with positive results. He said: “We anticipate topline results from this interim analysis in the first half of this year. This timing allows for the subset of patients required for the interim analysis of ORR to achieve a response and for the durability of responses to be appropriately evaluated.”