For a study, researchers sought to provide 5-year findings from CheckMate 227 Part 1 in which nivolumab with ipilimumab, regardless of tumor programmed death ligand 1 (PD-L1) status, increased overall survival (OS) against chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC).
Randomization involved adults with stage IV/recurrent NSCLC, without EGFR mutations or ALK changes, and tumor PD-L1 ≥1% or <1% (N=1739). Nivolumab with ipilimumab, nivolumab alone, or chemotherapy were the first-line treatments for patients with tumors with PD-L1 levels ≥1%. Nivolumab plus ipilimumab, Nivolumab plus chemotherapy, or chemotherapy were the treatment options offered to patients with tumors with PD-L1 < 1%. Endpoints included preliminary data on quality of life (QoL), safety, and effectiveness after 5 years.
Nivolumab with ipilimumab outperformed chemotherapy in terms of 5-year OS rates, 24% to 14% (PD-L1 ≥1%) at the minimum follow-up of 61.3 months, and 19% to 7% (PD-L1 <1%). The median response time was 24.5 months compared to 6.7 months (PD-L1 ≥1%) and 19.4 months compared to 4.8 months (PD-L1 <1%). By the 5-year time point, 66% (PD-L1 ≥1%) and 64% (PD-L1< 1%) of patients who had survived 5 years had stopped using nivolumab + ipilimumab without beginning further systemic anticancer therapy. Nivolumab + ipilimumab was discontinued because of adverse treatment events, although the survival advantage persisted, with a 5-year OS rate of 39% (combined PD-L1 ≥1% and <1% populations). Through a 5-year follow-up, the QoL in 5-year survivors who received nivolumab with ipilimumab was comparable to that of the general US population. There were no new warning signs of safety.
In comparison to chemotherapy, nivolumab with ipilimumab boosted 5-year survivability, including long-term, durable clinical benefit independent of tumor PD-L1 expression in all patients who had been off immunotherapy treatment for ≥3 years. The findings supported the first-line efficacy of nivolumab + ipilimumab for patients with mNSCLC.