Study drug LOXO-101 shrinks several types of tumor

The drug was effective against tumors in patients with various types of cancer and TRK gene fusions, researchers report.

By Stephen Feller

NEW ORLEANS, April 18 (UPI) -- A drug called LOXO-101 caused significant regression in various types of cancer among patients in a recent clinical trial, according to researchers.

The drug, under development by LOXO Oncology, inhibits tropomyosin receptor kinase, or TRK, and surprised researchers by stopping the progression of cancer in six patients with TRK fusion cancer in different parts of their bodies, researchers said during a presentation at the American Association for Cancer Research's 2016 annual meeting.


Early data was presented at another conference last year showing similar efficacy of the drug. The new presentation includes updated information on six TRK fusion patients, five of whom responded to the drug while the sixth showed more significant progress.

The researchers were surprised that all patients in the study with TRK gene fusions responded to the drug, though they said their results underscore the importance of genomic testing.

"In the case of this Phase I trial, many of the TRK fusion patients were detected as part of genomic testing, and I am encouraged to see that labs around the world are increasingly including TRK fusions in their routine testing menu," Dr. David Hong, an associate professor at the MD Anderson Cancer Center, said in a press release.


For the trial, which is still ongoing, researchers recruited 43 patients with a median age of 57 and advanced cancer, treating them with one of five dose levels.

Of the 43 participants, six had a type of cancer with a TRK fusion -- sarcoma, thyroid, salivary gland, gastrointestinal and non-small cell lung -- with a confirmed response to the drug. A seventh patient also showed regression, though the patient is at an earlier point in the study and has not yet met measurements considered a response.

A phase 2 trial is expected to start toward the end of 2016, with enrollment expected to start in the second half of the year, according to the drug's manufacturer.

"The consistent efficacy of LOXO-101 in patients with TRK gene fusions, independent of tumor type, is very exciting," Dr. Josh Bilenker, chief executive officer of Loxo Oncology, said in a press release. "These data suggest that LOXO-101 can deeply inhibit its target at a well-tolerated dose and generate durable disease control in a diverse group of patients with TRK gene fusions."

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