September 16, 2017
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Ensartinib shows promise in ALK-positive lung cancer

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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.

Perspective from Tom E. Stinchcombe, MD

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

Reference:

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.

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