Larotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers.

Authors

• Xiuning Le
• Christina Baik
• Jessica Bauman
• Jill Gilbert
• Marcia S Brose
• Juneko E Grilley-Olson
• Tejas Patil
• Ray McDermott
• Luis E Raez
• Jennifer M Johnson
• Lin Shen
• Makoto Tahara
• Alan L Ho
• Ricarda Norenberg
• Laura Dima
• Nicoletta Brega
• Alexander Drilon
• David S Hong

Publication/Presentation Date

5-10-2022

Abstract

BACKGROUND: Larotrectinib is a first-in-class, highly selective, and central nervous system-active tropomyosin receptor kinase (TRK) inhibitor approved for the treatment of adult and pediatric patients with TRK fusion cancer. We report the efficacy and safety of larotrectinib in patients with TRK fusion-positive salivary gland cancers.

PATIENTS AND METHODS: Patients with TRK fusion-positive salivary gland cancer treated with larotrectinib were identified from two clinical trials (NCT02122913 and NCT02576431). Patients received larotrectinib 100 mg twice daily (BID) except for one patient who received 150 mg BID in the phase I trial. The primary endpoint was objective response rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1.

RESULTS: At the data cut-off (July 20, 2020), 24 patients with TRK fusion-positive salivary gland cancer had been treated. The most common histologies were secretory carcinoma (54%), adenocarcinoma (25%), and mucoepidermoid carcinoma (13%). All 24 patients had an ETV6-NTRK3 gene fusion. The ORR was 92% (95% confidence interval, 73-99). Best overall response was complete response in three (13%) patients, partial response in 19 (79%), and progressive disease in two (8%). The rate of progression-free survival at 24 months was 78% (median follow-up 30.9 months). Most treatment-related adverse events (AEs) were grade 1-2, and no patients discontinued treatment due to AEs.

CONCLUSION: Larotrectinib demonstrated robust and durable efficacy in patients with TRK fusion-positive salivary gland tumors of various histologies, and a favorable safety profile. These findings support NTRK gene fusion testing in patients with advanced salivary gland cancers.

CLINICALTRIALS.GOV NUMBERS: NCT02122913 and NCT02576431.

Volume

29

Issue

6

First Page

779

Last Page

788

ISSN

1549-490X

Published In/Presented At

Le, X., Baik, C., Bauman, J., Gilbert, J., Brose, M. S., Grilley-Olson, J. E., Patil, T., McDermott, R., Raez, L. E., Johnson, J. M., Shen, L., Tahara, M., Ho, A. L., Norenberg, R., Dima, L., Brega, N., Drilon, A., & Hong, D. S. (2022). Larotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers. The oncologist, 29(6), e779–e788. Advance online publication. https://doi.org/10.1093/oncolo/oyac080

Disciplines

Medicine and Health Sciences

PubMedID

35536733

Department(s)

Hematology-Medical Oncology Division

Document Type

Article