ASCEND-3: A single-arm, open-label, multicenter phase II study of ceritinib in ALKi-naïve adult patients (pts) with ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC).

8060 Background: Ceritinib demonstrated clinical activity in ALKi-pretreated and -naive pts with ALK+ NSCLC, including those with brain metastases (BM; pivotal ASCEND-1 study). ASCEND-3 (NCT01685138) evaluated efficacy and safety of ceritinib in ALKi-naive pts. Methods: At 27June 2014 data cutoff, 124 pts enrolled worldwide received oral ceritinib 750 mg/d. Whole body (WB) and intracranial (I) responses were assessed by investigator. Prior chemotherapy (≤3 lines) was permitted. Results: Median age of enrolled pts was 56 (27–82); 40.3% were male, 59.7% Asian and 38.7% Caucasian; 40.3% had BM, of which 46% had no prior brain radiation (BRT). Median time from initial diagnosis to treatment start was 13.5 (1.0–283.1) mos; median exposure duration was 8.0 (0.1–16.2) mos; median follow-up (range) was 8.3 (0.6-16.3) mos. Investigator-assessed efficacy outcomes are located in the table below. At baseline 10 pts had investigator-assessed measurable brain lesions (MBL); IDCR was 80.0% (95% CI: 44.4, 97.5); in 6 pts...