The following article features coverage from the European Society for Medical Oncology (ESMO) 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Second- or subsequent-line nivolumab monotherapy for advanced non-small cell lung cancer (NSCLC) is associated with lower overall survival (OS) rates in real-world settings than the rates seen in clinical trial settings, according to a retrospective analysis presented in a poster session at the 2019 European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain.

In clinical trials, nivolumab was associated with superior OS compared with docetaxel among patients with previously treated squamous or nonsquamous NSCLC, noted study author David D. Stenehjem, PharmD, BCOP, associate professor and associate department head, department of pharmacy practice and pharmaceutical sciences at the University of Minnesota in Duluth. 

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But a retrospective analysis of electronic health record data in the Flatiron Health database found that patients with advanced nonsquamous or squamous NSCLC “had numerically lower OS than patients in registrational trials, likely due to inclusion of patients with more impaired function,” Dr Stenehjem reported. Progression-free survival (PFS) was “similar” to experience in clinical trials but “may be measured differently in routine clinical practice,” Dr Stenehjem added. 

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The analysis included 3023 adult patients with squamous NSCLC treated between March 1, 2015, and December 31, 2018, and patients with nonsquamous NSCLC who were treated between October 1, 2015, and December 31, 2018. Inclusion criteria included prior treatment with at least 1 platinum-based chemotherapy regimen and (if indicated) a targeted agent therapy. Patients who had previously received immunotherapy were not included in the analysis. Approximately two-thirds (65.2%) of patients had nonsquamous NSCLC and 34.8% had squamous histology. Most patients received nivolumab as a second-line therapy (83% of nonsquamous NSCLC patients and 85.3% of squamous NSCLC patients), with the others receiving third- or fourth-line nivolumab monotherapy.  

Median OS was 8.5 months (95% CI, 7.9-9.3 months) among 1972 nonsquamous NSCLC patients and 7.4 months (95% CI, 6.8-8.5 months) among 1051 patients with squamous NSCLC. The 12- and 18-month OS rates were 40% and 31%, respectively, for nonsquamous NSCLC and 36% and 24%, respectively, for patients with squamous histology.

Median PFS was 3.2 months and 3.0 months for nonsquamous and squamous NSCLC, respectively. And 12- and 18-month PFS rates were 17% and 12%, respectively, for nonsquamous NSCLC and 15% and 10%, respectively, for squamous NSCLC. 

Additional analyses are planned with additional follow-up to assess long-term outcomes for second- or later-line nivolumab monotherapy in patients with NSCLC, Dr Stenehjem noted. 

Disclosure: The study was funded by Bristol-Myers Squibb, and Dr Stenehjem disclosed financial relationships with various pharmaceutical companies. For a full list of disclosures, please refer to the abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ESMO annual meeting by visiting the conference page.


  1. Stenehjem DD. Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States. Presented at: ESMO Congress 2019; Madrid, Spain: September 8-12, 2017. Abstract 1498P.