Efficacy

Overall and Intracranial Response
LORBRENA demonstrated a 48% overall ORR and an intracranial response in more than half of the patients (60%) with brain metastases
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Per Independent Central Review (ICR).

Intracranial ORR and duration of response were assessed per ICR in a subgroup of 89 patients with measurable baseline lesions in the CNS according to RECIST version 1.1. Of these, 56 (63%) patients received prior brain radiation, including 42 patients (47%) who completed brain radiation treatment at least 6 months before starting treatment with LORBRENA.

CNS=central nervous system; NR=not reached; ORR=overall response rate; RECIST=Response Evaluation Criteria in Solid Tumors.
 
Exploratory Analyses Were Conducted in Subgroups Defined by Prior Therapy
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§With or without prior chemotherapy.

||As their only ALK inhibitor.

Alectinib, ceritinib, or brigatinib, with or without prior chemotherapy.2