Array BioPharma secured breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI), in combination with binimetinib (MEKTOVI) and cetuximab for the treatment of patients with a specific form of metastatic colorectal cancer (mCRC).
The breakthrough therapy designation is for metastatic colorectal cancer patients who are positive to BRAFV600E mutation as detected by an FDA-approved test, following failure of one to two prior lines of therapy for their metastatic condition.
According to Array BioPharma, mCRC patients with the type of mutation have a mortality risk which is more than twice that of mCRC patients without the mutation. As of now, there are no therapies approved specifically for this high unmet need population.
The breakthrough therapy designation will help expedite the development and review of the BRAFTOVI/MEKTOVI/cetuximab combo that is intended to treat the serious condition where preliminary clinical evidence hints that it may produce substantial improvement over available therapies on one or more clinically significant endpoints.
Victor Sandor – Chief Medical Officer of Array BioPharma, said: “We are delighted that the FDA has recognized the potential of this combination for patients with BRAFV600E-mutant metastatic colorectal cancer.
“As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need.”
The breakthrough therapy designation for the BRAFTOVI/MEKTOVI/cetuximab combo was based on the Phase 3 BEACON CRC safety lead-in data. The overall survival (OS) data from the late-stage trial were fully mature through 12.6 months and the median OS had not yet been reached, reported Array BioPharma.
The US pharma company said that one-year overall survival rate for the cohort was 62%. On the other hand, median progression-free survival (mPFS) for the patient arm subjected to the triple combo was 8 months which is similar between patients who got a prior line of therapy and patients getting a couple of prior lines of therapy.
Array BioPharma revealed that confirmed overall response rate (ORR) was 48% and in the 17 patients who got only one prior line of therapy, the ORR was found to be 62%.
Further, the triple combination, which is being investigated for the treatment of BRAFV600E-mutant metastatic colorectal cancer, was well-tolerated generally with no unexpected toxicities.