The results showed that mature median OS was 15.3 months (95% CI, 9.6–not reached) for patients treated with the triplet. These data will be presented on Saturday, January 19 at the ASCO 2019 Gastrointestinal Cancers Symposium in San Francisco, California.
Updated median progression-free survival and updated confirmed overall response rate results for patients treated with the triplet in the safety lead-in remain the same, as previously reported, with eight months mPFS (95% CI, 5.6-9.3) and a 48% ORR (95% CI, 29.4–67.5). Among the 17 patients who received only one prior line of therapy, the ORR was 62%.
A BRAF mutation is present in up to 15% of all patients with mCRC and V600 is the most common BRAF mutation.
BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no US Food and Drug Administration -approved therapies specifically indicated for this high unmet need population.
The triplet combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue, anemia, increased creatine phosphokinase, increased aspartate aminotransferase and urinary tract infections. The rate of grade 3 or 4 skin toxicities continued to be lower than generally observed with Erbitux in mCRC.
On August 7, 2018, Array announced that the FDA granted Breakthrough Therapy Designation to Braftovi, in combination with Mektovi and Erbitux for the treatment of patients with BRAFV600E-mutant mCRC as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease.
The triplet combination of Braftovi, Mektovi and Erbitux for the treatment of patients with BRAFV600E-mutant mCRC is investigational and not approved by the FDA.
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