Nivolumab, Ipilimumab With or Without Chemotherapy Shows Long-Term, Durable Benefit in Metastatic NSCLC

The combination of nivolumab and ipilimumab, with or without chemotherapy, showed a “long-term, durable clinical benefit” in patients with metastatic non-small cell lung cancer (NSCLC) and tumor PD-L1 <1%, according to CheckMate 227 and CheckMate 9LA studies.

Follow-up data from the CheckMate 9LA clinical trial previously illustrated that first-line nivolumab plus ipilimumab and chemotherapy demonstrated a long-term, durable overall survival (OS) benefit in patients with NSCLC, compared to chemotherapy alone. Survival outcomes were also previously shown to be higher with chemotherapy regardless of tumor PD-L1 <1% expression.

The randomized phase 3 studies assessed patients over 18 years of age with stage IV/recurrent NSCLC and no sensitizing EGFR or ALK alterations. Among the patients with tumor PD-L1 <1% who received nivolumab and ipilimumab with or without chemotherapy (n=322), the median OS was 17.4 months, as opposed to 11.3 months among patients who received chemotherapy alone (n=315). The 5-year OS rates were 20% versus 7%, respectively. The median follow-up was 73.7 months for both groups.

The OS benefit was also noted across difficult-to-treat populations, from patients with squamous NSCLC (hazard ratio [HR], 0.51; 95% CI, 0.36-0.72) to those with baseline brain metastases (HR, 0.44; 95% CI, 0.26-0.75). In the chemotherapy cohort, the median progression-free survival (PFS) was 4.9 months, with a 5-year PFS rate of 2%, versus a median PFS of 5.4 months and a 5-year PFS rate of 9% in the immunotherapy cohort with or without chemotherapy.

The objective response rate (ORR) was 22% in patients receiving chemotherapy alone, compared to a rate of 29% in those receiving nivolumab plus ipilimumab with or without chemotherapy. The median duration of responses were 4.6 months versus 18 months, respectively.

According to the researchers, “nivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 <1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need.”

Source: Journal of Thoracic Oncology