Array Biopharma Inc (NASDAQ:ARRY) a biopharma firm company focused on the development, commercialization and discovery of targeted small molecule cancer treatments, released financial report for its 2Q2017 and offered an update on the advancement of its major clinical development plans.
Ron Squarer, the CEO, reported that they were delighted to post that COLUMBUS met its main endpoint and shown a robust PFS benefit linked with the combination of binimetinib and encorafenib versus vemurafenib in subjects with BRAF-mutant melanoma. Following a pre-NDA discussion with the FDA, they anticipate to submit an NDA for COLUMBUS in June/July.
Novartis continues to notably support all ongoing studies with encorafenib and binimetinib that were planned or active as of the completion of the Novartis Agreements in FY2015, including the COLUMBUS and NEMO Phase 3 studies. Reimbursement revenue was almost $130 million for the preceding 12 months, of which revenue of $27.9 million was noted over the quarter closing December 31, 2016.
In November 2016, report from the pivotal Phase III COLUMBUS study of encorafenib and binimetinib treatment in patients suffering with BRAF-mutant melanoma were presented. The study achieved its main objective, with the combination of enco/ bini significantly enhancing progression free survival as against vemurafenib.
In the assessment of the primary objective, the median PFS for patients cured with the combination of enco/ bini was 14.9 months compared to 7.3 months for people cured with vemurafenib. As part of the study design, the primary assessment was dependent on a BICR of patient scans, while comes by local assessment at the investigative site were analyzed.
Array Biopharma reported that the combination of enco/ bini also showed an improvement in confirmed ORR, the ability to offer a high dose intensity to most of the people and an advantage in respect of keeping quality of life for patients.