Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers

At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

Larotrectinib is an investigational oral, selective investigational drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving TRKs. Growing research suggests that NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

As of the July 17, 2017, data cut-off date, 24 pediatric patients were enrolled in the dose-escalation portion of the phase I trial, including 17 patients with TRK fusion cancers. These 17 patients carried primary diagnoses of infantile fibrosarcoma, thyroid cancer, and various soft-tissue sarcomas. Among those with TRK fusion cancers, 94% either remain on larotrectinib or have received surgery with curative intent; 4 patients have been followed for longer than 1 year, and a total of 12 have been followed for more than 6 months. The overall response rate in patients with TRK fusions was 93%, as assessed by both the investigators and an independent review committee.

The larotrectinib adverse event profile is consistent with data previously presented publicly. The most common treatment-related adverse events at the phase II dose included increased liver function tests, nausea, and neutropenia.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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