Concordance Between Tissue <i>ALK</i> Detection by Immunohistochemistry and Plasma <i>ALK</i> Detection by Next-Generation Sequencing in the Randomized Phase 3 ALEX Study in Patients With Treatment-Naive Advanced <i>ALK</i>-Positive NSCLC.

ABSTRACT:

Introduction

The Blood First Assay Screening Trial revealed the clinical applicability of blood-based next-generation sequencing to identify patients with ALK-positive NSCLC for alectinib treatment. To understand the relationship between tissue-based versus blood-based testing, we retrospectively investigated concordance between VENTANA ALK (D5F3) CDx immunohistochemistry and the FoundationACT (FACT; Foundation Medicine, Inc.) plasma assay, and compared clinical efficacy between phase 3 ALEX study subpopulations.

Methods

Patients with advanced ALK-positive (by immunohistochemistry) NSCLC were randomized 1:1 to alectinib 600 mg or crizotinib 250 mg, twice daily. Assessable baseline plasma samples were analyzed for ALK positivity by FACT; positive percent

SUBMITTER: Noe J 

PROVIDER: S-EPMC9218556 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature