Ensartinib in the treatment of anaplastic lymphoma kinase‐positive locally advanced or metastatic patients with lung squamous or adenosquamous carcinoma: A real‐world, retrospective study

Abstract Aim To report the efficacy and safety of ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, in treating patients with ALK‐positive advanced lung squamous cell carcinoma (LUSC) or lung adenosquamous carcinoma (LASC) in China. Methods This retrospective study analyzed data for 36 advanced‐stage patients with ALK‐positive LUSC (cohort A) and 13 patients with ALK‐positive LASC (cohort B) between December 16, 2020 and December 16, 2021. All patients received once‐daily ensartinib 225 mg. Outcome analysis included the demographic characteristics, tumor response, progression‐free survival (PFS), and treatment‐related adverse events (TRAE). Results Among the 49 patients, the majority were under 65 years old (73.5%), non‐smokers (85.7%), had an Eastern Cooperative Oncology Group Performance Status of 0–1 (77.6%), and were at stage IV (71.4%). All patients were included in the efficacy and safety analysis. Seven PFS events were reported in cohort A while no patients experienced PFS events in cohort B. The median PFS was not estimable for both cohorts. In cohort A, the objective response rate (ORR) was 63.9%, and the disease control rate (DCR) was 83.3%. In the cohort B, the ORR was 76.9% and the DCR was 100.0%. Rash was the only TRAE reported in the cohort A (8.3%) and cohort B (23.1%). No patients had grade 3 or higher TRAE. Conclusion Ensartinib has been tentatively proven favorable efficacy and tolerability in the treatment of patients with ALK‐positive advanced LUSC or LASC in the real‐world. However, confirmatory studies are still needed in larger sample sizes.