Perspective from Tom E. Stinchcombe, MD
September 16, 2017
2 min read

Ensartinib shows promise in ALK-positive lung cancer

Perspective from Tom E. Stinchcombe, MD
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CHICAGO — Ensartinib appeared safe and effective in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, according to study results presented at International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

Ensartinib (X-396, Xcovery) — a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor — has demonstrated antitumor activity in patients who previously received a second-generation ALK TKI.

Leora Horn, MD, MSc, clinical director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, and colleagues conducted the multicenter phase 1/phase 2 trial to evaluate ensartinib in patients with advanced solid tumors.

In the phase 1 portion of the study, patients received a variety of doses, ranging from 25 mg to 250 mg once daily on a continuous 28-day schedule. Researchers selected a dose of 225 mg for further evaluation in the phase 2 expansion.

Patients in this phase were required to have ALK-positive NSCLC and measurable disease.

Researchers divided patients into cohorts of those who were ALK TKI naive; who progressed on prior crizotinib (Xalkori; Pfizer, EMD Serono) and had not received a second-generation ALK TKI; who progressed on a second-generation ALK TKI; those with central nervous system metastases; and those with leptomeningeal disease.

The current analysis included 22 patients (median age, 52) with ALK-positive NSCLC who previously received at least one second-generation ALK TKI at a dose of 200 mg or more. Sixty-eight percent of patients had an ECOG performance status of 1.

Patients appeared to be heavily pretreated, with a median of four prior regimens and three prior lines of ALK TKI therapy.

Six patients were not evaluable for efficacy.

Of the other 19 patients, five (26%) achieved a partial response and six (32%) achieved stable disease for a disease control rate of 58%.

Among three patients with baseline target CNS lesions, one patient achieved intracranial response and one patient had stable disease.

Horn noted enrollment is ongoing in the expansion cohorts.

“eXalt 2 is ongoing and enrolling patients post-progression on crizotinib or alectinib [Alecensa, Genentech],” she added. “eXalt3 is a phase 3 trial that is ongoing to compare ensartinib with crizotinib in TKI-naive ALK-positive NSCLC patients.” – by Kristie L. Kahl


Horn L, et al. Abstract OA03.08. Presented at: International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology; Sept. 14-16, 2017; Chicago.

Disclosure: Horn is a speaker/adviser for AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech/Roche, Merck and Xcovery; and participated on the steering committee for Bristol-Myers Squibb, Janssen and Merck.