Abstract
BACKGROUND: CNS progression results in frequent treatment failure for ALK+ NSCLC patients receiving the ALK inhibitor crizotinib. CNS efficacy is important in assessing new ALK inhibitors and accurate assessment of response/progression is vital in determining treatment efficacy. Data from two phase II studies in pre-treated ALK+ NSCLC were pooled to examine the CNS efficacy of the highly selective ALK inhibitor alectinib, using both Response Evaluation Criteria in Solid Tumors (RECIST) and Response Assessment in Neuro-Oncology (RANO) criteria to evaluate brain metastases. METHODS: The phase II, single-arm, multicenter studies both enrolled ALK+ NSCLC patients aged ≥18 years who had previously received crizotinib. NP28761 was conducted in North America only (NCT01871805); NP28673 was a global study (NCT01801111). All patients in both studies received 600mg oral alectinib twice daily. Patients underwent imaging at baseline to assess CNS metastases and CNS response was determined by an independent review committee (IRC) according to RECIST v1.1 or RANO criteria. RESULTS: Fifty-one patients had baseline measurable CNS disease by IRC according to RECIST v1.1, and 43 according to RANO criteria. The CNS objective response rate (ORR) was 60.8% by RECIST (95% CI 46.1–74.2; 9 CNS complete responses [CRs]; CNS disease control rate [DCR] 90.2%) and 51.2% by RANO (95% CI 35.5–66.7; 5 CNS CRs; CNS DCR 83.7%). Responses by RECIST included both confirmed and unconfirmed responses; those by RANO had to be confirmed. Median duration of CNS response was 9.1 months with RECIST (95% CI 5.8–NE; 39% of responders with event) and 9.1 months with RANO (95% CI 7.4–NE; 36% of responders with event). CONCLUSION: Alectinib demonstrated promising and durable efficacy in the CNS for ALK+ NSCLC patients previously treated with crizotinib, regardless of the assessment criteria used. Updated results from a later cut-off, plus correlative data and additional analyses, will be presented.
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