Tuesday March 19, 2019 0 comments
BOULDER -- Array BioPharma Inc. (NASDAQ: ARRY) announced the National Comprehensive Cancer Network (NCCN) has updated their Clinical Practice Guidelines in Oncology for Colon and Rectal Cancer to include BRAFTOVI in combination with MEKTOVI and an anti-EGFR antibody as a Category 2a treatment for patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after failure of one or two prior lines of therapy for metastatic disease.
The BRAFV600E mutation is associated with a poor prognosis compared to patients with CRC who do not carry the BRAF mutation, and currently there are no FDA-approved therapies specifically for this high unmet need population.
"With no current FDA-approved therapies for BRAF CRC, this combination represents an important treatment option for this patient population," said Scott Kopetz, associate professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
"Historical published benchmarks in BRAFV600E-mutant mCRC patients, whose disease has progressed after one or two prior lines of therapy, are an overall response generally between 4% to 8%, a median progression-free survival of 2 to 3 months and median overall survival of 4 to 6 months.
“The NCCN recommendation underscores the potential for this triplet combination to benefit these patients in critical need."
The NCCN based its recommendation on data from the safety lead-in of the BEACON CRC trial evaluating the triplet combination of BRAFTOVI in combination with MEKTOVI and ERBITUX (cetuximab), in 29 patients with BRAFV600E-mutant mCRC.
As presented at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI), confirmed overall response rate (ORR) and median progression-free survival (mPFS) results for patients treated with the triplet in the safety lead-in demonstrated 48% ORR (95% CI, 29.4–67.5) and 8 months mPFS (95% CI, 5.6-9.3). ORR by central assessment, 41% (95% CI 24%–61%), was consistent with local assessment. Mature median overall survival (OS) was 15.3 months (95% CI, 9.6–not reached) for patients with BRAF-mutant mCRC treated with the triplet.
"Patients with BRAFV600E-mutant mCRC are in great need of effective treatment options," said Ron Squarer, Array CEO.
"Based on data from the safety lead-in portion of the BEACON CRC Phase 3 trial, the FDA granted Breakthrough Therapy Designation in August 2018 for BRAFTOVI, in combination with MEKTOVI and cetuximab 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.
“We look forward to the interim analysis of the randomized portion of the trial in the first half of this year."
As presented at ASCO GI, 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 (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 was lower than generally observed with ERBITUX in mCRC.
Worldwide, colorectal cancer is the third-most-common type of cancer in men and the second-most-common in women, with approximately 1.4 million new diagnoses in 2012. Globally in 2012, approximately 694,000 deaths were attributed to colorectal cancer.