Abstract
Background: Lorlatinib is the third generation inhibitor of ALK and ROS1 tyrosine kinase has shown activity in patients with crisotinib-refractory ALK-positive NSCLC most of whom had CNS metastases. We report results of the overall and intracranial antitumor activity of patients with crisotinib-refratory ALK-positive NSCLC. Methods: Patients with ALK and ROS1-positive NSCLC who had progressed after crisotinib and at least one regimen of chemotherapy with or without CNS metastases with ECOG PS was 0-2 and adequate organ functions were given lorlatinib 100 mg orally once daily continuously. Primary endpoint -overall and intracranial objective response, secondary endpoint - safety of lorlatinib. Results: Since January 2017 to July 2018 39 patients were enrolled: ALK+- 36, ROS1+ - 3 pts. Median age 49 years. 27 pts had brain metastases. Objective response was achieved in 22 pts (56, 4%) - 3 complete (7,7%) and 19 partial (48,7%) responses. 16 pts (41%) had stabilization as the best response, 1 ALK+ pt progressed...References
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