The TRK inhibitor larotrectinib prolongs survival when compared with non-TRK inhibitor standard care in adults with TRK fusion-positive cancers, according to an analysis published in JCO Precision Oncology.

Researchers found that larotrectinib was associated with a 78% lower risk of death and a nearly 4-fold longer median overall survival, when compared with standard care.

For this study, researchers compared data from 85 patients enrolled in 3 clinical trials of larotrectinib to real-world data from 28 patients who received non-TRK inhibitor standard care.

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Patients in both groups had locally advanced or metastatic TRK fusion-positive cancers, including colorectal cancer, non-small cell lung cancer, salivary gland cancer, breast cancer, endometrial cancer, stomach cancer, biliary tract cancer, uterine cancer, soft tissue sarcoma, and cancer of unknown primary.

All patients were 18 years or older, were TRK inhibitor-naïve, and had received 4 or fewer prior lines of systemic therapy. Patients in the 2 groups were matched by age, ECOG performance status, prior lines of systemic therapy, NTRK1, disease stage, brain metastases, and tumor type.

After matching, larotrectinib was associated with a 78% lower risk of death compared with standard care (adjusted hazard ratio, 0.22; 95% CI, 0.09-0.52; P =.001).  The median overall survival was 39.7 months in the larotrectinib group and 10.2 months in the standard care group.  

The researchers noted that larotrectinib was approved on the basis of 3 single-arm trials, and trials comparing larotrectinib to other therapies head-to-head have not been possible due to the rarity of TRK fusions. 

“We contribute evidence in the absence of a randomized trial to support clinical decision-making and guideline generation within patients with TRK fusion-positive cancers,” the researchers wrote.

Disclosures: This study was supported by Bayer. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Bokemeyer C, Paracha N, Lassen U, et al. Survival outcomes of patients with tropomyosin receptor kinase fusion-positive cancer receiving larotrectinib versus standard of care: A matching-adjusted indirect comparison using real-world data.  JCO Precision Oncol. Published online January 23, 2023. doi:10.1200/PO.22.00436