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Exelixis Announces Presentation Of Updated Phase 1b Data For Cobimetinib (GDC-0973/XL518) In Combination With Vemurafenib At ECC 2013

Study Results

As 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.

While the study was not designed to measure efficacy, updated results showed a partial or complete response (tumor shrinkage) in many of the patients who had not been previously treated with a BRAF inhibitor. Of the 63 BRAFi-naïve patients, 10% had a complete response, 75% had a partial response, and 13% had stable disease, for an objective response rate of 85%. Most objective responses occurred by the time of the first tumor assessment at 6 weeks. Only two of the BRAFi-naïve patients (3%) had progressive disease. Sixty-one of the 65 patients who had progressed on prior vemurafenib therapy were evaluated for tumor response by RECIST, of which 15% had a partial response, and 43% had stable disease, for an objective response rate of 15%. As of the June 21, 2013 cut-off date, with a median follow-up time of three months, 85.2% of vemurafenib-progressors had already experienced disease progression, and the median progression-free survival (PFS) was 2.8 months. At a median follow-up time of 10 months, 33.3% of BRAFi-naïve patients had experienced disease progression, and the median PFS had not yet been reached.

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