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Research Article|Articles in Press, 100483

Real-world Comparative Effectiveness of First-Line Alectinib Versus Crizotinib in Patients with Advanced ALK-Positive NSCLC with or without Baseline Central Nervous System Metastases

Open AccessPublished:February 23, 2023DOI:https://doi.org/10.1016/j.jtocrr.2023.100483
Real-world Comparative Effectiveness of First-Line Alectinib Versus Crizotinib in Patients with Advanced ALK-Positive NSCLC with or without Baseline Central Nervous System Metastases
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      ABSTRACT

      Background

      Alectinib demonstrated superior efficacy to crizotinib in the phase 3 ALEX study and is a preferred initial treatment for patients with advanced ALK-positive NSCLC. To understand the efficacy of alectinib in US clinical practice, we conducted a retrospective real-world comparative effectiveness analysis of first-line alectinib versus crizotinib.

      Methods

      Adults with advanced ALK-positive NSCLC who received first-line alectinib (from December 11, 2015) or crizotinib (from January 01, 2014) were included from a real-world database. Propensity scores were applied to balance baseline characteristics. Real-world data (RWD), including progression-free survival (rwPFS), overall survival (rwOS), time to new CNS metastases (rwTTNCM), and outcomes in patients with/without baseline CNS metastases were analysed. The ALEX-like RWD cohort (filtered by ALEX laboratory eligibility criteria) was used to compare real-world comparative effectiveness with ALEX.

      Results

      The RWD cohort comprised 364 patients (141 alectinib; 223 crizotinib); rwPFS (weighted hazard ratio [wHR] = 0.46; 95% CI: 0.33–0.65) and rwOS (wHR = 0.46; 95% CI: 0.31–0.69) were significantly improved with alectinib versus crizotinib. In patients with baseline brain scans, a significant rwPFS benefit was seen regardless of baseline CNS metastases. rwTTNCM was delayed with alectinib versus crizotinib in patients with (wHR = 0.28, 95% CI: 0.16–0.52) and without (wHR = 0.42, 95% CI: 0.24–0.76) baseline CNS metastases. The ALEX-like RWD cohort comprised 325 patients (120 alectinib; 205 crizotinib); alectinib showed similar rwPFS benefits with ALEX.

      Conclusions

      Outcomes were significantly improved with first-line alectinib versus crizotinib in patients with advanced ALK-positive NSCLC in the US real-world setting.

      Keywords

      Article info

      Publication history

      Accepted: February 16, 2023
      Received in revised form: February 3, 2023
      Received: October 14, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Funding: This work was funded by F. Hoffmann-La Roche Ltd. No grant number is applicable.

      Conflict of Interest: QZ, NP, and HT are employees of Genentech, Inc. JJL has served as a compensated consultant for Genentech, C4 Therapeutics, Blueprint Medicines, Nuvalent, Bayer, Novartis, Mirati Therapeutics, Elevation Oncology, Turning Point Therapeutics, and Regeneron; received honorarium and travel support from Pfizer; received institutional research funds from Roche/Genentech, Hengrui Therapeutics, Turning Point Therapeutics, Neon Therapeutics, Relay Therapeutics, Bayer, Elevation Oncology, Linnaeus Therapeutics, Nuvalent, and Novartis; and received CME funding from OncLive, MedStar Health, and Northwell Health. LP, MH, VS, NK, and VA are employees of F. Hoffmann-La Roche Ltd. MGK has participated in advisory boards for Achilles Therapeutics, Bayer, Guardant Health, Janssen, Roche, Seattle Genetics; undertaken consultancy and/or speaker bureaus for AstraZeneca, Janssen, and Roche; received travel grants from BerGenBio and Immutep; and received research grants from BerGenBio and Roche.

      CRediT Authorship Contribution Statement

      Qing Zhang: Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Visualization, Writing - original draft, Writing - review & editing

      Jessica J. Lin: Investigation, Supervision, Writing - review & editing

      Navdeep Pal: Conceptualization, Investigation, Methodology, Visualization, Writing - original draft, Writing - review & editing

      Letizia Polito: Conceptualization, Methodology, Project administration, Resources, Supervision, Writing - review & editing

      Huong Trinh: Conceptualization, Methodology, Writing - review & editing

      Magalie Hilton: Methodology, Writing - review & editing

      Vlatka Smoljanović: Conceptualization, Resources, Writing - review & editing

      Nino Kurtsikidze: Resources, Writing - review & editing

      Venice Archer: Conceptualization, Resources, Writing - review & editing

      Matthew G. Krebs: Conceptualization, Investigation, Supervision, Writing - review & editing

      Identification

      DOI: https://doi.org/10.1016/j.jtocrr.2023.100483

      Copyright

      © 2023 Published by Elsevier Inc. on behalf of the International Association for the Study of Lung Cancer.

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