107P Outcomes of patients with metastatic non-small cell lung cancer (mNSCLC) receiving first-line (1L) immunotherapy (IO) with or without chemotherapy (CT): Real-world (RW) evidence vs clinical trial results - CORRELATE

Recent data suggest that the overall survival (OS) and progression-free survival (PFS) observed in RW patients with mNSCLC receiving IO regimens may be shorter than that seen in randomised clinical trials (RCTs). This retrospective, observational study describes rwOS and rwPFS (overall and by PD-L1 expression) compared with the outcomes observed in RCTs in patients with mNSCLC. Eligible RW patients from the US Flatiron Enhanced Data-Mart database were those who developed stage IV mNSCLC, initiated 1L treatment with IO ± CT between 1 Nov 2016 and 31 May 2021, and met select eligibility criteria of 6 RCTs for IO regimens with a US approval in mNSCLC: KEYNOTE (KN) -024, KN-189, KN-407, IMpower150, CheckMate (CM) 9LA, and CM 227. Patients with brain metastases at diagnosis were excluded. Efficacy-effectiveness factors (EEFs) allowed evaluation of the gaps between RW and RCT outcomes. Most patient baseline characteristics (e.g., % male, ECOG/WHO performance status [PS], PD-L1 expression, and smoking status) differed by <10% between the RW and RCT datasets. Among patients with ECOG PS 0–1, rwOS and rwPFS were considerably shorter vs RCTs, with EEF ratios between 42–73% and 53–78%, respectively (Table). Similar results were observed by PD-L1 status, as applicable (not shown). Where sample size allowed, expanding the analysis to cohorts of PS 2 and PS 3–4, separately, showed even greater disparities in outcomes (not shown).Table: 107PRCTDatasetAnalytic NmOS95% CIOS EEF, %mPFS95% CIPFS EEF, %KN-024 pembroRCT 15430.018.3–NE54.010.36.7–NE56.3RW 79616.213.9–18.75.84.9–6.7KN-189 pembro+CTRCT 41022.019.5–25.255.99.08.1–9.965.6RW 183612.311.3–13.35.95.6–6.2KN-407 pembro+CTRCT 27817.214.4–19.772.78.06.3–8.577.5RW 41212.510.1–14.96.25.4–7.3IMpower150 atezo+bev+CTRCT40019.517.0–22.260.08.37.7–9.867.4RW 3111.78.1–27.25.63.6–9.8CM 9LA nivo+ipi+CTRCT36115.813.9–19.769.06.45.5–7.853.1RW 1710.92.0–NE3.41.2–5.9CM 227 nivo+ipiRCT39617.115.0–20.242.15.14.1–6.376.5RW 357.23.0–NE3.91.4–6.9EEF: estimated as median from RW/median from RCT ×100 m, median (months); NE, not estimable. Open table in a new tab EEF: estimated as median from RW/median from RCT ×100 m, median (months); NE, not estimable. IO has been established as the standard of care in mNSCLC; however, RW survival outcomes are considerably shorter than those reported in pivotal RCTs, even for indicated populations in the RW. Despite some limitations of the dataset and the US-only population, our RW findings are broadly consistent with other RW studies, highlighting the unmet need for more effective treatment options for RW patients with mNSCLC.