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Loxo's larotrectinib passes phase 1 trial for pediatric cancer patients

Loxo Oncology Inc. and Bayer AG reported that their cancer treatment, larotrectinib, showed a response in children with a number of cancers that contain a certain mutation.

The phase 1 trial evaluated the medicine in pediatric cancer patients with genetic alterations called tropomyosin receptor kinase gene fusions that result in uncontrolled signaling and tumor growth. TRK fusion is thought to occur in about 1% of a number of common cancers. The patients in the trial were diagnosed with either infantile fibrosarcoma, thyroid cancer or various soft tissue sarcomas.

The Scout trial showed a 93% overall response rate in patients with TRK fusion. Among all patients, 94% remain on the medication or received potentially curative surgery.

Larotrectinib is an investigational drug that is being developed between Bayer and Loxo Oncology. The U.S. Food and Drug Administration granted the medicine breakthrough therapy, rare pediatric disease, and orphan drug designations.

According to earlier research results, the medicine was effective against 17 different cancers, according to a presentation at the meeting of the American Society of Clinical Oncology in Chicago.

In November, Loxo and Bayer entered into an agreement for the development and commercialization of its cancer therapies LOXO-195 and larotrectinib. Loxo Oncology leads global development activities and U.S. regulatory activities for the drugs, while Bayer leads ex-U.S. regulatory and worldwide commercial activities.