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PURPOSE We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC), regardless of tumor programmed death ligand 1 (PD-L1) status. METHODS Adults with stage IV/recurrent NSCLC without EGFR mutations or ALK alterations and with tumor PD-L1 ≥1% or <1% (N=1739) were randomized. Patients with tumor PD-L1 ≥1% were randomized to first-line nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. Patients with tumor PD-L1 <1% were randomized to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy. Endpoints included exploratory 5-year results for efficacy, safety, and quality of life (QoL). RESULTS At 61.3 months’ minimum follow-up, 5-year OS rates were 24% versus 14% for nivolumab plus ipilimumab versus chemotherapy (PD-L1 ≥1%), and 19% versus 7% (PD-L1 <1%). Median duration of response was 24.5 versus 6.7 months (PD-L1 ≥1%) and 19.4 versus 4.8 months (PD-L1 <1%). Among patients surviving 5 years, 66% (PD-L1 ≥1%) and 64% (PD-L1 <1%) were off nivolumab plus ipilimumab without initiating subsequent systemic anticancer treatment by the 5-year time point. Survival benefit continued following nivolumab plus ipilimumab discontinuation due to treatment-related adverse events, with a 5-year OS rate of 39% (combined PD-L1 ≥1% and <1% populations). QoL in 5-year survivors treated with nivolumab plus ipilimumab was similar to the general US population through 5 years’ follow-up. No new safety signals were observed. CONCLUSION With all patients off immunotherapy treatment for ≥ 3 years, nivolumab plus ipilimumab increased 5-year survivorship versus chemotherapy, including long-term, durable clinical benefit regardless of tumor PD-L1 expression. These data support nivolumab plus ipilimumab as an effective first-line treatment for patients with mNSCLC.

Background: To compare survival outcomes of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who received immunotherapy as first-, second-or beyond line, versus matched patients receiving standard chemotherapy with special characterization of hyperprogressors. Methods: A retrospective cohort study of 296 patients with unresectable/metastatic NSCLC treated with either, first-, second-, third-or fourth-line of immunotherapy was conducted. A matched comparison with a historical cohort of first-line chemotherapy and a random forest tree analysis to characterize hyperprogressors was conducted. Results: Median age was 64 years (range 34-90), 40.2% of patients were female. A total of 91.2% of patients had an Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1. Immunotherapy as first-line was given to 39 patients (13.7%), second-line to 140 (48.8%), and as third-line and beyond to 108 (37.6%). Median overall survival was 12.7 months (95% CI 9.67-14 months) and progression-free survival (PFS) of 4.27 months (95% CI 3.97-5.0). Factors associated with increased survival included treatment with immunotherapy as first-line (P < 0.001), type of response (P < 0.001) and PD-L1 status (P = 0.0039). Compared with the historical cohort, immunotherapy proved to be superior in terms of OS (P = 0.05) but not PFS (P = 0.2). A total of 44 hyperprogressors were documented (19.8%,.1%]). Leukocyte count over 5.300 cells/dL was present in both hyperprogressors and long-term responders. Conclusions: Patients who receive immune-checkpoint inhibitors as part of their treatment for NSCLC have better overall survival (OS) compared with matched patients treated with standard chemotherapy, regardless of the line of treatment.

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