Brief report: Safety and antitumor activity of alectinib plus atezolizumab from a phase 1b study in advanced ALK-positive NSCLC Journal Article


Authors: Kim, D. W.; Gadgeel, S.; Gettinger, S. N.; Riely, G. J.; Oxnard, G. R.; Mekhail, T.; Schmid, P.; Dowlati, A.; Heist, R. S.; Wozniak, A. J.; Singh, J.; Cha, E.; Spahn, J.; Ou, S. H. I.
Article Title: Brief report: Safety and antitumor activity of alectinib plus atezolizumab from a phase 1b study in advanced ALK-positive NSCLC
Abstract: Introduction: Alectinib is a preferred first-line treatment option for advanced ALK-positive NSCLC. Combination regimens of alectinib with immune checkpoint inhibitors are being evaluated for synergistic effects. Methods: Adults with treatment-naive, stage IIIB/IV, or recurrent ALK-positive NSCLC were enrolled into a two-stage phase 1b study. Patients received alectinib 600 mg (twice daily during cycle 1 and throughout each 21-d cycle thereafter) plus atezolizumab 1200 mg (d8 of cycle 1 and then d1 of each 21-d cycle). Primary objectives were to evaluate safety and tolerability of alectinib plus atezolizumab. Secondary objectives included assessments of antitumor activity. Results: In total, 21 patients received more than or equal to 1 dose of alectinib or atezolizumab. As no dose-limiting toxicities were observed in stage 1 (n = 7), the starting dose and schedule were continued into stage 2 (n = 14). Median duration of follow-up was 29 months (range: 1–39). Grade 3 treatment-related adverse events occurred in 57% of the patients, most often rash (19%). No grade 4 or 5 treatment-related adverse events were reported. Confirmed objective response rate was 86% (18 of 21; 95% confidence interval [CI]: 64–97). Median progression-free survival was not estimable (NE) (95% CI: 13 mo–NE), neither was median overall survival (95% CI: 33 mo–NE). Conclusions: The combination of alectinib and atezolizumab is feasible, but increased toxicity was found compared with the individual agents. With small sample sizes and relatively short follow-up, definitive conclusions regarding antitumor activity cannot be made. © 2022 The Authors
Keywords: alectinib; atezolizumab; non–small cell lung cancer; alk-positive; phase 1b study
Journal Title: JTO Clinical and Research Reports
Volume: 3
Issue: 8
ISSN: 2666-3643
Publisher: Elsevier BV  
Date Published: 2022-08-01
Start Page: 100367
Language: English
DOI: 10.1016/j.jtocrr.2022.100367
PROVIDER: scopus
PMCID: PMC9304608
PUBMED: 35875467
DOI/URL:
Notes: Conference Paper -- Export Date: 1 August 2022 -- Source: Scopus
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  1. Gregory J Riely
    601 Riely