First-line therapy consisting of nivolumab plus ipilimumab showed a consistent safety profile in special populations with advanced non–small cell lung cancer (NSCLC), according to research presented by Fabrice Barlesi, MD, PhD, of Aix-Marseille University, Assistance Publique Hôpitaux de Marseille at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract OA04.02).
CheckMate 817
CheckMate 817 was initiated due to limited data on the safety and efficacy of immunotherapy in patients with advanced NSCLC with other comorbidities, such as brain metastases, kidney and renal disease, and human immunodeficiency virus (HIV).
“First-line flat-dose nivolumab plus weight-based ipilimumab showed a consistent safety profile in special populations with advanced NSCLC, including those with ECOG PS 2."— Fabrice Barlesi, MD, PhD
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Dr. Barlesi and researchers at other sites involved in CheckMate 817 tested two groups of patients with previously untreated advanced NSCLC. Cohort A1 consisted of 198 patients with an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 2 or ECOG PS 0–1 with asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection. The other group of patients (cohort A) totaled 391 and had an ECOG PS of 0–1.
An ECOG PS 2 score indicates the patient is ambulatory and able to take care of himself or herself, but cannot engage in most work activities. An ECOG PS 1 score indicates the patient is ambulatory and able to conduct most activities, whereas a patient with PS 0 has virtually no restrictions.
Patients with known EGFR mutations or ALK translocations sensitive to available targeted therapy were excluded from both cohorts. Each group received a flat dose of nivolumab plus a weight-based low dose of ipilimumab for 2 years, or until disease progression or unacceptable toxicity.
Results
Both groups of patients experienced similar rates of treatment-related adverse events, but the overall response rate was 25% in cohort A1 and 35% in cohort A. Progression-free survival was shorter in cohort A1 than cohort A.
“First-line flat-dose nivolumab plus weight-based ipilimumab showed a consistent safety profile in special populations with advanced NSCLC, including those with ECOG PS 2. Patients with either high tumor mutational burden or higher tumor programmed cell death ligand 1 expression appeared to exhibit improved efficacy,” concluded Dr. Barlesi.
Disclosure: For full disclosures of the study authors, visit wclc2019.iaslc.org.
