Background: Leveraging data from a collaboration with 9 data partners, Friends of Cancer Research convened the Real-world Evidence Pilot 2.0, to examine trends and real world (rw) data endpoints in immunotherapy (IO) use for the front line treatment of aNSCLC.

Methods: This study leveraged parallel analyses of rw data elements across heterogenous data sources (EHR, administrative claims, and registry) to: a) describe trends in uptake and use of novel IO frontline therapy after advanced diagnosis in NSCLC patients treated in usual care settings and b) examine associations between treatment and rw outcomes at one-year follow-up. The proportion of patients treated on each regimen (IO single agent, chemo, or IO + chemo) from 2011 through 2017 were calculated. Analysis included proportion of patients across treatment regimens stratified by year to describe post approval uptake of IO. Kaplan-Meier survival estimates were reported to adjust for follow-up time and stratified by PD-L1 status and stage.

Results: Seven datasets identified a range of 999 to 4617 patients per dataset for this analysis. Across datasets, 2508, 3446, and 4176 patients initiated treatment in 2015, 2016, and 2017, respectively. No patients received IO or IO + chemo regimens prior to 2015. Initial approvals for IO use in aNSCLC occurred in October 2015 and for first line in metastatic NSCLC in October 2016. When examining survival at 1 year, overall, OS in PD-(L)1 + patients appeared longer than those with a PD-(L)1 – status.

Conclusions: RWE analyses may reveal important trends in clinical cancer patient care including patterns of off-label use. The heterogeneity in the timing of IO uptake across datasets ranged from immediately after approval to ~12 months post-approval.

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