AACR II: Early-Phase Study of Ensartinib in ALK-Positive NSCLC
Posted: Friday, July 10, 2020
The ALK tyrosine kinase inhibitor (TKI) ensartinib exhibited antitumor activity and a tolerable safety profile in Chinese patients with advanced ALK-positive non–small cell lung cancer (NSCLC), according to Hongyun Zhao, MD, of the Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues. The phase I trial, which was presented during the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II (Abstract 579/4), established 225 mg as the recommended phase II dose.
A total of 43 patients had ALK-positive disease, and 5 had ROS1 fusion–positive disease. Of those with ALK-positive disease, 32 were ALK TKI–naive, and 11 were ALK TKI–resistant. Oral ensartinib was administered across dose levels of 150, 200, 225, and 250 mg.
At least one treatment-related adverse event occurred in all patients. Events of grade 3 or higher were reported in 39.6% of patients; skin rashes occurred most frequently (16.7%). The compound was moderately absorbed and slowly eliminated, with a half-life of between 21 and 30.2 hours.
In 46 evaluable patients, the objective response and disease control rates were 71.7% and 84.8%, respectively. A total of 32 patients achieved a partial response, and 1 patient achieved a complete response. In addition, the objective response and disease control rates in patients with ALK-positive disease were 80.5% and 87.8%, respectively. In patients treated with at least 225 mg, the objective response and disease control rates were 68.6% and 85.7%, respectively. The objective response rate was higher in ALK TKI–naive patients (90%) than in ALK TKI–resistant patients (54.5%). In the 16 patients with brain metastases, both the objective response and disease control rates were 75%. The median duration of progression-free survival was reported for each subgroup: ALK-positive (20.4 months); ALK TKI–naive (24.5 months); ALK TKI–resistant (4.2 months); ROS1 fusion (8.6 months); and total patient population (17.1 months).
Disclosure: For full disclosures of the study authors, visit abstractsonline.com.
