# Real-world characteristics and survival outcomes of patients with metastatic ALK fusion-positive solid tumors treated with standard-of-care therapies

## TL;DR

This study finds that ALK fusions in metastatic solid tumors are linked to worse survival outcomes compared to wild-type tumors, suggesting a need for targeted therapies.

## Contribution

The study is the first to analyze real-world survival outcomes of ALK fusion-positive solid tumors outside of lung cancer, highlighting their poor prognosis.

## Key findings

- ALK fusion-positive tumors had consistently lower median overall survival compared to ALK wild-type tumors.
- Co-alterations were rare in the ALK fusion-positive cohort.
- ALK fusions appear to have a negative prognostic effect in metastatic solid tumors.

## Abstract

Anaplastic lymphoma kinase (ALK) fusions can be found in different solid tumors. This study aims to describe the clinical characteristics and investigate survival outcomes of patients with ALK fusion-positive solid tumors (excluding non-small cell lung cancer [NSCLC]) treated with standard-of-care therapies in a real-world setting.

Data for patients with metastatic solid tumors (excluding NSCLC) who had ≥1 Foundation Medicine comprehensive genomic profiling (CGP) test between January 1, 2011 and September 30, 2023, were obtained from a nationwide (US-based) de-identified multi-tumor clinico-genomic database. Patients with ALK wild-type (ALK-WT) tumors were matched with patients with ALK fusion-positive tumors (4:1 ratio) using pre-specified baseline characteristics. Two models were used to analyze survival outcomes: Model 1 used the CGP report date as the index date; Model 2 used the date of metastatic diagnosis as the index date (including adjustment for immortal time bias).

Overall, 22 and 88 patients were included in the ALK fusion-positive and ALK-WT cohorts, respectively. Co-alterations were rare in the ALK fusion-positive cohort. Median overall survival was consistently lower in patients with ALK fusion-positive tumors compared with patients with ALK-WT tumors, across all analyses (hazard ratios between 1.8 and 2.0).

Data from this study suggest that ALK fusions have a negative prognostic effect in metastatic solid tumors and highlight the need for further investigation of ALK inhibitors in the tumor-agnostic setting.