Tivantinib: Additional Phase I data

Data from 16 melanoma patients in an extension cohort of an open-label, dose-escalation, U.S. and Italian Phase I trial showed that twice-daily 360 mg oral tivantinib plus Nexavar sorafenib led an overall response rate (ORR) of 25%, including 1 complete response and 3 partial responses, plus 3 cases of stable disease. Median progression-free survival (PFS) was 5.3 months. In 8 patients with neuroblastoma RAS viral (v-Ras) oncogene (NRAS) mutations, median PFS was 9.2 months. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The partners previously reported data from 9 evaluable patients in the Phase I trial showing that tivantinib plus Nexavar produced 6 cases of stable disease for 8-29 weeks, including 1 renal cell carcinoma (RCC) patient with 22% tumor regression. The recommended Phase II dose was twice-daily 360 mg ARQ 197 plus twice-daily 400 mg Nexavar (see BioCentury, May 31, 2010). ...