Roche reports positive preliminary Phase III results in metastatic melanoma
Basel – Roche AG’s orally ATP-competitive BRAF(V600E) kinase blocker RG7204 (PLX4032, RO5185426) has achieved secondary endpoint in an ongoing open label Phase III study comparing overall survival in 675 treatment-naive metastatic melanoma patients treated with either RO5185426 or the DNA alkylating chemotherapeutic dacarbazine. After one year of treatment, patients who received the inhibitor of BRAF signalling lived longer without their disease progression (progression-free survival) compared to the dacarbazine arm. Additionally, melanoma patients receiving twice daily 960 mg of RO5185426 lived longer than patients receiving one 1000 mg injection every 3 weeks of the current standard of care, according to preliminary data. The BRIM 3 trail with RO5185426 (NCT01006980) is to be completed by 2014. Patients who carry a BRAF(V600E) mutation identified by Roche’s Cobas companion diagnostics test show permanent activation of MAPK and ERK that results in tumour cell proliferation. The mutated BRAF protein is found in about half of all cases of metastatic melanoma. RO5185426 blocks BRAF(V600E) kinase signalling in the cell. The compound is being co-developed with Plexxikon Inc since 2006.