Loxo Oncology Inc. reported positive interim results from three ongoing clinical trials where its investigational drug larotrectinib is being used to treat patients whose cancers harbor a specific genetic mutation.
The therapy is a form of precision medicine where tumor genetics rather than the tumor site of origin define the treatment approach. It targets a genetic abnormality in the tumor known as tropomyosin receptor kinase fusion, which can contribute to tumor cell growth. TRK fusion is thought to occur in about 1% of a number of common cancers.
The various types of cancer the patients suffered from included appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal stromal tumor, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer and certain sarcomas.
The combined data from the three studies demonstrated a 76% confirmed objective response rate across tumor types in a patient population that included 43 adults and 12 children.
The company said it expects to submit a new drug application for larotrectinib, or LOXO-101, in late 2017 or early 2018. The drug has been granted breakthrough therapy, rare pediatric disease and orphan drug designations by the U.S. Food and Drug Administration.
Loxo had previously announced a partnership with Roche Holding Ltd. unit Ventana Medical Systems Inc. to develop a test that would identify the cancer patients that could be treated with larotrectinib.