Tafinlar dabrafenib: Additional Phase III data

Additional data from the open-label, international Phase III COMBI-v (MEK116513) trial in 704 previously untreated patients with stage IIIC or stage IV BRAF V600E or V600K mutation-positive melanoma showed that twice-daily 150 mg Tafinlar dabrafenib plus once-daily 2 mg Mekinist trametinib reduced the risk of death by 31% vs. twice-daily 960 mg Zelboraf vemurafenib (HR=0.69, p=0.005). Median OS was not reached in the Tafinlar plus Mekinist arm vs. 17.2 months for Zelboraf. The 12-month OS rate was 72% for the combination arm vs. 65% for Zelboraf. Tafinlar plus Mekinist also met the secondary endpoint of improving median PFS vs. Zelboraf (11.4 vs. 7.3 months, p<0.001). Tafinlar plus Mekinist led to an ORR of 64%, including 47 complete responses, vs. an ORR of 51% for Zelboraf, including 27 complete responses. Median duration of response was 13.8 months for the combination arm vs. 7.5 months for Zelboraf. Data were published in New England Journal of Medicine. ...