1. Outcomes According to ALK Status Determined by Central Immunohistochemistry or Fluorescence In Situ Hybridization in Patients With ALK-Positive NSCLC Enrolled in the Phase 3 ALEX Study
- Author
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Ting Liu, Krzysztof Konopa, Emanuela Pozzi, Isabell Loftin, Johannes Noe, Solange Peters, Charles C. Williams, Shirish M. Gadgeel, Tony Mok, Dong Wan Kim, Alice T. Shaw, Sai-Hong Ignatius Ou, and D. Ross Camidge
- Subjects
0301 basic medicine ,Pulmonary and Respiratory Medicine ,Alectinib ,Oncology ,medicine.medical_specialty ,Population ,03 medical and health sciences ,0302 clinical medicine ,hemic and lymphatic diseases ,Internal medicine ,medicine ,In patient ,education ,education.field_of_study ,ALK Break Apart FISH Probe Kit ,medicine.diagnostic_test ,Crizotinib ,business.industry ,Hazard ratio ,030104 developmental biology ,030220 oncology & carcinogenesis ,Immunohistochemistry ,business ,Fluorescence in situ hybridization ,medicine.drug - Abstract
Introduction We retrospectively examined progression-free survival (PFS) and response by ALK fluorescence in situ hybridization (FISH) status in patients with advanced ALK immunohistochemistry (IHC)-positive NSCLC in the ALEX study. Methods A total of 303 treatment-naive patients were randomized to receive twice-daily alectinib 600 mg or crizotinib 250 mg. ALK status was assessed centrally using Ventana ALK (D5F3) CDx IHC and Vysis ALK Break Apart FISH Probe Kit. Primary end point is investigator-assessed PFS. Secondary end points of interest are objective response rate and duration. Results Investigator-assessed PFS was significantly prolonged with alectinib versus crizotinib in ALK IHC-positive and FISH-positive tumors (n = 203, 67%) (hazard ratio [HR] = 0.37, 95% confidence interval [CI]: 0.25–0.56; p Conclusions Outcomes of patients with ALK IHC-positive and FISH-positive and ALK IHC-positive and FISH-uninformative NSCLC were similar to those of the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.
- Published
- 2021
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