Fabrice Barlesi, MD, PhD
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 at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC).1Fabrice Barlesi, MD, PhD, of Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, presented the study, 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).
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 of 2 or an ECOG performance score of 0 or 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 performance score of 0 or 1.
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 the programed cell death protein 1 immune checkpoint inhibitor nivolumab plus a weight-based low dose of the monoclonal antibody ipilimumab for 2 years, or until disease progression or unacceptable toxicity.
Safety and Efficacy
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.
In a news release issued by IASLC, Dr. Barlesi said: “First-line flat-dose nivolumab plus weight-based ipilimumab showed a consistent safety profile in special populations with advanced NSCLC, including those with ECOG performance score 2. Patients with either high tumor mutational burden or higher tumor programmed cell death ligand 1 expression appeared to exhibit improved efficacy.” ■
Disclosure: Dr. Barlesi has provided advisory or consultancy services and received personal fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Clovis, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Pierre Fabre, Pfizer, Roche, and Takeda.
1. Barlesi F, Audigier-Valette C, Felip E, et al: CheckMate 817: First-line nivolumab + ipilimumab in patients with ECOG PS 2 and other special populations with advanced NSCLC. 2019 World Conference on Lung Cancer. Abstract OA04.02. Presented September 8, 2019.