Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study.
Year: 2025
Type: conference-abstract
Abstract: 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.
Source: Journal of Clinical Oncology
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Chinese People's Liberation Army, Wuhan Union Hospital, Huazhong University of Science and Technology, First Hospital of China Medical University, Sichuan University, West China Hospital of Sichuan University, First Affiliated Hospital of Dalian Medical University, Sun Yat-sen University Cancer Center, Third Affiliated Hospital of Harbin Medical University, Tongji Hospital, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Second Affiliated Hospital of Zhejiang University, Ningxia Medical University, Ningxia Medical University General Hospital, Taihe Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410820646