Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study.

8024 Background: Ensartinib has been approved as ALK-positive locally advanced/metastatic NSCLC, but its role in adjuvant therapy remains unknown. This real-world study aimed to evaluate the efficacy and safety of ensartinib as adjuvant therapy in ALK-positive NSCLC. Methods: Data were retrospectively collected from “Ensacove Patient Assistance Program" held by Betta pharmaceutical company. The patients who were ≥18 years-old and had completely resected, histologically confirmed stage I-III NSCLC as classified according to the eighth edition of AJCC/UICC, were documented ALK-positive, and had at least one post-baseline CT scan. The primary endpoint is 2-year disease-free survival (DFS) rate. Secondary endpoints include DFS, safety and OS. Results: From November 19, 2020, to May 31, 2024, a total of 296 patients were screened. 222 patients were enrolled. The median age was 55 years-old. 128 females. 98 (44.1%) were stage I, 42 (18.9%) were stage II, 82 (36.9%) were stage III. 98.2% were lung adenocarcinoma. Thirty-two patients (14.4%) received postoperative chemotherapy. The median duration of ensartinib treatment was 25.3 (95% confidence intervals [CI], 3.1-47.2) months. At the data-cutoff date of December 29, 2024, median follow-up time was 23.5 months (95% CI, 21.7-26.2). The median DFS was immature. The 2-year DFS rate was 92.1% (95% CI, 86.6%-95.5%) for all patients, and 89.3% (95% CI, 77.9%-95.0%), 100.0% (95% CI, NR-NR) and 91.0% (95% CI, 80.6%-95.9%) for patients with stage I, stage II, and stage III, respectively. 16 patients had disease recurrence or death, including 7 patients with local recurrence and 9 patients with distant metastasis. The OS data was immature with only 2 deaths occurred. The treatment-related adverse events (TRAEs) of any grade occurred in 169 patients (76.1%), and 11 patients (5.0%) experienced ≥grade 3 TRAEs. The most common TRAEs were rash (60.8%). Serious TRAEs were 8 (3.6%) patients. TRAEs led to dose reductions, dose interruptions and permanent discontinuation were 21.2%, 9.0% and 3.2% of the patients, respectively. No deaths due to TRAEs were reported. Conclusions: To our knowledge, this real-world study has the largest sample size on postoperative adjuvant therapy with ALK inhibitors. In this real-world setting, ensartinib demonstrated encouraging efficacy and well-tolerated safety profile among stage IA1-IIIB ALK-positive NSCLC, providing a potential adjuvant therapy option in this patient population.