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- W2890721204 abstract "9009 Background: Alectinib has proven systemic and CNS efficacy in patients (pts) with ALK+ aNSCLC (ALEX study). Tumor cell death caused by alectinib may release antigens broadening the potential anti-tumor T cell response. The monoclonal antibody atezolizumab (atezo) releases T cell suppression by inhibiting PD-L1 binding and improves OS in second-line NSCLC treatment. We hypothesized atezo in combination with alectinib would lead to enhanced efficacy. Methods: This phase Ib enrolled treatment-naïve pts with ALK+ aNSCLC regardless of PD-L1 status, including pts with untreated asymptomatic brain metastases. Pts received alectinib 600 mg PO BID for 7 days (safety evaluation), followed by alectinib 600 mg PO BID with atezo 1200 mg IV q3w (expansion stage) until progression or unacceptable toxicity. The primary objective was to evaluate the safety and tolerability of the combination. Secondary objectives included evaluation of tumor response (ORR) per RECIST v1.1. Results: At cut-off (18 August 2017) 21 pts (safety stage n = 7; expansion stage n = 14) who received ≥1 dose of alectinib or atezo were considered safety evaluable. Median age was 53 years. Incidence of grade 3 and serious adverse events (AEs) were 62% (52.4% treatment-related) and 33%, respectively. No grade 4–5 AEs were reported. Four pts (19%) discontinued atezo and 2 pts (10%) discontinued alectinib due to AEs. 14 pts (67%) had alectinib dose interruptions/modifications. No dose-limiting toxicities were observed. At a median follow up of 13 months, (1–22), ORR was 81% (95% CI 58.1–94.6); median progression-free survival was 21.7 months (95% CI 10.3–21.7), median duration of response was 20.3 months (95% CI 11.5–20.3), however, only 6 pts had progressed at the time of data cut-off. On-treatment CD8+ T-cell increase was observed post-alectinib run-in. Conclusions: Combination of full dose alectinib and atezo appears to have an acceptable safety profile with no new safety findings for either agent. Early efficacy results are encouraging but further follow-up is needed to define the role of this combination in pts with treatment-naïve ALK+ NSCLC." @default.
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- W2890721204 date "2018-05-20" @default.
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- W2890721204 title "Safety and clinical activity results from a phase Ib study of alectinib plus atezolizumab in <i>ALK</i>+ advanced NSCLC (aNSCLC)." @default.
- W2890721204 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.9009" @default.
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