Loxo Oncology to seek approval of larotrectinib after the drug shows 76% response in pediatric cancers

US biotech Loxo Oncology (Nasdaq: LOXO) revealed at the American Society of Clinical Oncology (ASCO) meeting in Chicago that it will be seeking US Food and Drug Approval for its for larotrectinib as a treatment for patients with TRK fusion-positive tumors along with presenting new data showing that  three-quarters of participants in a combined analysis responded to the drug.

Loxo announced interim clinical data from all three ongoing larotrectinib (LOXO-101) clinical trials in patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions, which showed a 76% confirmed objective response rate (ORR) across tumor types). The larotrectinib pediatric data, included in this presentation, are also being presented in a separate oral presentation on Monday, June 5. Loxo has been singled out by the organizers of ASCO as being of particular interest.

“Larotrectinib delivers consistent and durable responses in TRK fusion patients across all ages, regardless of tumor context, and does so with few side effects,” said David Hyman, the NAVIGATE global principal investigator and chief of the early drug development service at Memorial Sloan Kettering Cancer Center who will present the data at ASCO. “In this way, the larotrectinib TRK fusion story fulfills the promise of precision medicine, where tumor genetics rather than tumor site of origin define the treatment approach. It is now incumbent upon the clinical oncology and pathology communities to examine our testing paradigms, so that TRK fusions and other actionable biomarkers become part of the standard patient workup.”