67P - Molecular testing and treatment of patients with advanced solid tumors harboring an NTRK gene fusion: Interim results of the REALTRK registry

Background

Neurotrophic Tyrosine Receptor Kinase gene fusions involving either NTRK1, NTRK2 or NTRK3 (encoding the tropomyosin receptor kinases TRKA, TRKB and TRKC, respectively) are oncogenic drivers. The overall prevalence of NTRK fusion-positive tumors is ∼0.30%, though frequencies vary by tumor type, with >90% reported for some rare tumor types such as secretory carcinoma of the breast and salivary glands. In Europe, the TRK inhibitors (TRKi) entrectinib and larotrectinib, both showing high clinical activity and favorable safety profiles, have received tumor-agnostic approval based on pooled data of non-comparative phase I/II clinical trials with limited patient numbers.

Methods

REALTRK is a retro- and prospective, observational, intersectoral, multicenter cohort study in Germany and Switzerland (NCT04557813). Enrollment of 120 patients (pts) with advanced solid tumors harboring an NTRK fusion diagnosed with a validated assay according to ESMO recommendations is planned. Pts with detailed information on NTRK testing qualify for complete documentation, including demographic and clinical characteristics, details on NTRK testing, treatment, outcome, and safety of TRKi. Furthermore, physician-reported factors on NTRK testing and treatment decision making as well as patient-reported outcomes on quality of life (EORTC QLQ-C30) are assessed.

Results

At data cut-off (Sept 30^th, 2022), 18 pts have been enrolled at 13 sites in Germany and Switzerland. Of those, 12 pts were eligible for complete documentation. Median age at diagnosis of NTRK fusion was 60.7 years and median time from NTRK fusion diagnosis to start of TRKi therapy, received by 11 pts, was 0.9 months. Tumor entities and data on NTRK fusions are presented in the table.

Conclusions

REALTRK provides valuable data on NTRK testing and treatment reality of pts with NTRK fusion-positive solid tumors and generates clinically relevant real-world evidence. Table: 67P

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

iOMEDICO AG.

Funding

Roche GmbH.

Disclosure

A. Bleckmann: Financial Interests, Personal, Advisory Role: Alexion, Gilead, Novartis, Bristol-Myers Squibb, Bayer, Servier, Roche, AstraZeneca, Takeda, Merck, BeiGene, MSD, Lilly, ArtTempi, Jannsen-Cilag, Amgen, Boehringer Ingelheim. M. Zaiss: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Bristol-Myers Squibb, Celgene, Esai, Gilead, Hexal, Jannsen, Lilly, Novartis, Pierre-Fabre, Pfizer, Roche, Vifor. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, iOMEDICO. B. Kasenda: Financial Interests, Personal, Advisory Board: Astellas, Roche. All other authors have declared no conflicts of interest.