Real-world outcomes of immunotherapy–based regimens in first-line advanced non-small cell lung cancer

David Waterhouse, Jenny Lam, Keith A. Betts, Lei Yin, Sophie Gao, Yong Yuan, John Hartman, Sumati Rao, Solomon Lubinga, David Stenehjem

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4 Scopus citations


Background: First-line (1L) immunotherapy (I-O) has improved outcomes in patients with advanced non-small cell lung cancer (NSCLC) in clinical trials and is now routinely used alone or combined with chemotherapy. Although efficacy and safety of I-O therapies have been established in clinical trials, little is known about their performance and long-term efficacy in the real-world setting. We aimed to characterize real-world outcomes for patients with advanced NSCLC treated with 1L I-O therapy in the United States. Methods: Patients aged ≥18 years with confirmed advanced (stage III–IV) NSCLC who received either 1L I-O monotherapy or single-agent I-O combined with chemotherapy on or after January 1, 2016 were identified from the Flatiron Health database. Primary objectives were to examine overall survival (OS) and real-world progression-free survival. Index date was defined as date of 1L treatment initiation; data cut-off date was June 30, 2020. Results: Among 4271 patients receiving I-O plus chemotherapy, median OS was 10.6 (95 % confidence interval [CI], 9.3–11.8) months in patients with squamous NSCLC (n=814) and 12.0 (95 % CI, 11.3–12.8) months in those with non-squamous disease (n=3457). Regardless of histology, patients with high (≥50 %) tumor programmed death ligand 1 (PD-L1) expression demonstrated longer median OS vs those with low expression. Among 3041 patients receiving I-O monotherapy, median OS was 11.3 (95 % CI, 9.8–12.8) months in patients with squamous NSCLC (n=875) and 14.1 (95 % CI, 12.4–15.8) months in those with non-squamous disease (n=2166). OS benefit appeared to be greatest in the ≥50 % tumor PD-L1 expression group of the non-squamous cohort. Conclusion: Survival estimates were generally lower than those reported in pivotal clinical trials. These findings indicate that there remains room for improvement of real-world survival outcomes in patients with advanced NSCLC who receive 1L I-O–based regimens and for identification of subgroups of patients not benefitting from treatment with current I-O regimens.

Original languageEnglish (US)
Pages (from-to)41-49
Number of pages9
JournalLung Cancer
StatePublished - Jun 1 2021

Bibliographical note

Funding Information:
Keith Betts, Sophie Gao and Lei Yin are employees of Analysis Group which received research funding for the work under consideration. David Stenehjem has received personal fees from Bristol Myers Squibb, Dracen Pharmaceuticals, Iterion Therapeutics, Molecular Templates, and Salarius Pharmaceuticals; grants from Bristol Myers Squibb, AstraZeneca, Bayer, Novartis, and Jazz Pharmaceuticals. John Hartman, Jenny Lam, Solomon Lubinga and Sumati Rao are employees of Bristol Myers Squibb.

Funding Information:
Research funding for this study was provided by Bristol Myers Squibb .

Publisher Copyright:
© 2021 Bristol Myers Squibb


  • Immune checkpoint inhibitors
  • Immunotherapy
  • Non-small cell lung cancer
  • Real-world outcomes

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't


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