Study ResultsAs of June 21, 2013, 128 patients had been treated, comprising 65 patients who had disease progression while receiving vemurafenib and 63 patients who were BRAFi-naïve. Of the 63 BRAFi-naïve patients, 42 (67%) were previously untreated and 21 (33%) had been treated with agents other than a BRAFi. The majority of patients had Stage IV, M1c melanoma at the time of enrollment (vemurafenib-progressors = 82%, BRAFi naïve = 70%). Dose-limiting toxicities were reported in one of six patients in the dose-escalation stage receiving 960 mg of vemurafenib bid and 60 mg of cobimetinib qd on a 21/7-day schedule (Grade 3 QT interval prolongation), and in one of five patients in the dose escalation stage receiving 960 mg of vemurafenib bid and 80 mg cobimetinib qd on a 14/14-day schedule. Dose-limiting toxicities of Grade 3 mucositis and Grade 3 arthralgia were each observed in one of four patients in the dose-escalation stage receiving 960 mg vemurafenib bid and 60 mg cobimetinib qd on a 28/0-day schedule. Two cohorts receiving 60 mg of cobimetinib qd on a 21/7-day schedule with vemurafenib at either 720 mg or 960 mg bid were selected for expansion.
Exelixis Announces Presentation Of Updated Phase 1b Data For Cobimetinib (GDC-0973/XL518) In Combination With Vemurafenib At ECC 2013
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