ARTICLE | Product Development

TRK or treat baskets

How Ignyta, Loxo are designing cancer trials based on molecular signature

November 9, 2015 8:00 AM UTC

Loxo Oncology Inc. and Ignyta Inc. are each running Phase II trials of TRK inhibitors that could possibly lead to the first drug labels for cancers defined by molecular signature alone. If they succeed, it would represent a paradigm shift in approvals of targeted agents; however, both companies are also prepared to pursue approval based on histologically defined cancers if need be.

On Sept. 30 Ignyta started the STARTRK-2 study of entrectinib (RXDX-101) in patients whose tumors harbor an oncogenic fusion protein caused by mutations in any of the molecule's three targets. Entrectinib inhibits c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1), anaplastic lymphoma kinase (ALK) and the tropomyosin receptor kinase (TRK) family, which includes neurotrophic tyrosine kinase receptor 1 (TrkA; NTRK1), TrkB and TrkC...