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.

Introduction: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% or greater tumor programmed death ligand 1 expression had significantly improved overall survival with nivolumab plus ipilimumab versus chemotherapy. We present the patient-reported outcomes (PROs). Methods: Patients (N ¼ 1189) were randomized to nivolumab plus ipilimumab, nivolumab, or chemotherapy. PROs were exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index, LCSS 3-item global index, EQ-5D visual analog scale (VAS), and EQ-5D utility index were analyzed descriptively. Mixed-effect model repeated measures and time-to-first deterioration and improvement analyses were conducted.

After controlling for a number of potentially confounding factors, multiple-inhaler users had more exacerbations, a higher risk of exacerbation, and higher healthcare resource utilization and costs compared to single-inhaler users.

DPNP is a significant complication of diabetes with multiple impacts for patient functioning and well-being, which increase the burden of disease.

Exacerbations, especially severe ones, result in a significant economic burden for third-party payers. Effective management of COPD and prevention of exacerbations may lead to improved patient outcomes and reduction in total healthcare costs for long-term management of COPD.