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Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC

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dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorGadgeel, Shirish-
dc.contributor.authorGettinger, Scott N.-
dc.contributor.authorRiely, Gregory J.-
dc.contributor.authorOxnard, Geoffrey R.-
dc.contributor.authorMekhail, Tarek-
dc.contributor.authorSchmid, Peter-
dc.contributor.authorDowlati, Afshin-
dc.contributor.authorHeist, Rebecca S.-
dc.contributor.authorWozniak, Antoinette J.-
dc.contributor.authorSingh, Jatinder-
dc.contributor.authorCha, Edward-
dc.contributor.authorSpahn, Jessica-
dc.contributor.authorOu, Sai-Hong Ignatius-
dc.date.accessioned2022-10-17T04:17:24Z-
dc.date.available2022-10-17T04:17:24Z-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.created2022-10-12-
dc.date.issued2022-08-
dc.identifier.citationJTO Clinical and Research Reports, Vol.3 No.8, p. 100367-
dc.identifier.issn2666-3643-
dc.identifier.urihttps://hdl.handle.net/10371/186194-
dc.description.abstract© 2022 The AuthorsIntroduction: 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.-
dc.language영어-
dc.publisherElsevier-
dc.titleBrief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC-
dc.typeArticle-
dc.identifier.doi10.1016/j.jtocrr.2022.100367-
dc.citation.journaltitleJTO Clinical and Research Reports-
dc.identifier.wosid001137481600011-
dc.identifier.scopusid2-s2.0-85134565430-
dc.citation.number8-
dc.citation.startpage100367-
dc.citation.volume3-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusCELL LUNG-CANCER-
dc.subject.keywordPlusOPEN-LABEL-
dc.subject.keywordPlusMULTICENTER-
dc.subject.keywordPlusCRIZOTINIB-
dc.subject.keywordAuthorAlectinib-
dc.subject.keywordAuthorALK-positive-
dc.subject.keywordAuthorAtezolizumab-
dc.subject.keywordAuthorNon–small cell lung cancer-
dc.subject.keywordAuthorPhase 1b study-
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