Monday January 22, 2018 0 comments
BOULDER -- Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant metastatic colorectal cancer (CRC) whose disease has progressed after one or two prior regimens.
The data was presented at the ASCO 2018 Gastrointestinal Cancers Symposium in San Francisco.
In patients with the BRAF mutation, Array said the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR)* in patients with the BRAF mutation was 48%, and 3 patients achieved complete responses (CR).
Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy. These data represent substantial improvements compared to several separate historical published standard of care benchmarks for this population, Array said.
"We are very excited about these safety lead-in results, which show both an unprecedented progression-free survival and overall response rate in patients with BRAFV600-mutant colorectal cancer," said Scott Kopetz, associate professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.
"To put these data in context, the observed median progression-free survival of 8 months exceeds historical benchmarks of approximately 2 months for median progression-free survival, and 4 to 6 months for median overall survival, with current standards of care in this patient population,” Kopetz said.
“These results demonstrate the potential of the triplet combination to benefit this population of patients who currently have very limited effective treatment options."
In the safety lead-in, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to adverse events (AEs) with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30).
All patients with elevated baseline levels of the tumor markers CEA and CA19-9 had a reduction from baseline, with similar and substantial (median 83% - 96%) reductions across both markers in patients with objective responses and those with stable disease.
Enrollment in the randomized portion of the BEACON CRC trial is ongoing. Patients interested in participating in the trial may talk to their doctor to have their tumor tested for the BRAF mutation for eligibility to enroll in this new and important trial.
Further details on the trial are available at clinicaltrials.gov (NCT02928224).
A PDF of the ASCO 2018 Gastrointestinal Cancers Symposium presentation can be found on Array's website: http://www.arraybiopharma.com/download_file/282/