CHECKMATE 9LA BRAIN METASTASES PLUS

We report updated data with 3-year minimum follow-up.Īdults with previously untreated, histologically confirmed, unresectable MPM and Eastern Cooperative Oncology Group performance status of ≤1 were randomized 1 : 1 to nivolumab (3 mg/kg every 2 weeks) plus ipilimumab (1 mg/kg every 6 weeks) for up to 2 years, or six cycles of platinum plus pemetrexed chemotherapy. In the phase III CheckMate 743 study ( NCT02899299), first-line nivolumab plus ipilimumab significantly improved overall survival (OS) versus chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). 20 Thoracic Oncology Department, Early Phases Unit-CIC INSERM 1425-CLIP2 Paris Nord, Bichat-Claude Bernard Hospital, AP-HP, University Cancer Institute Paris, Paris, France.19 Department of Informatics and Predictive Sciences, Bristol Myers Squibb, Princeton, USA.18 Translational Medicine, Bristol Myers Squibb, Princeton, USA.17 Biostatistics, Bristol Myers Squibb, Princeton, USA.16 Oncology Clinical Development, Bristol Myers Squibb, Princeton, USA.15 Lung Unit, Royal Marsden Hospital, London, UK Institute of Cancer Research, London, UK.14 Division of Medical Oncology, Mayo Clinic, Rochester, USA.13 Department of Thoracic/Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, USA.12 Department of Medical Oncology, Okayama Rosai Hospital, Okayama, Japan.11 Medical School, University of Western Australia and Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, Australia.10 Department of Thoracic Oncology, Netherlands Cancer Institute and Leiden University Medical Center, Amsterdam, The Netherlands.9 Medical Oncology, Institut de Cancérologie de l'Ouest, Site René Gauducheau, Boulevard Jacques Monod, Saint-Herblain Cedex, France.8 Department of Pulmonology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.7 The Sunrise Centre, Royal Cornwall Hospitals NHS Trust, Truro, UK.6 Medical Oncology, Medical School, Dicle University, Diyarbakir, Turkey.5 Aix Marseille University, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.4 Pulmonary and Thoracic Oncology Department, Hôpital Côte de Nacre C H U Caen, Caen, France.3 Pulmonary Medicine, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.Electronic address: 2 Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France. 1 Oncology Department, Lausanne University Hospital, Lausanne, Switzerland.With a 3-year minimum follow-up, nivolumab plus ipilimumab with two cycles of chemotherapy continued to have long-term, durable efficacy versus chemotherapy alone a manageable safety profile and survival benefit in patients with or without baseline brain metastases or select somatic mutations, further supporting the regimen as first-line treatment for patients with metastatic NSCLC. Extended follow-up revealed no new safety signals. A trend of OS benefit was observed in patients treated with nivolumab plus ipilimumab with chemotherapy versus chemotherapy alone, despite KRAS, TP53, and STK11 tumor mutations. Efficacy outcomes were improved in patients with pretreated baseline brain metastases (median OS: 19.3 versus 6.8 mo systemic PFS: 9.7 versus 4.1 mo intracranial PFS: 11.4 versus 4.6 mo ). With a minimum follow-up of 36.1 months, nivolumab plus ipilimumab with chemotherapy continued to prolong OS versus chemotherapy alone in the intent-to-treat population (median OS: 15.8 versus 11.0 mo 3-y OS: 27% versus 19%). Exploratory analyses included systemic and intracranial efficacy in patients with or without baseline brain metastases, in addition to OS and PFS by KRAS, TP53, STK11, and KEAP1 somatic mutation status in patients with nonsquamous NSCLC. Assessments included OS, progression-free survival (PFS), and objective response rate. We report updated efficacy and safety (≥3 y of follow-up), clinical outcomes in patients with baseline brain metastases, and exploratory somatic mutation analyses.Īdults with stage IV or recurrent NSCLC, no known sensitizing EGFR or ALK alterations, and Eastern Cooperative Oncology Group performance status less than or equal to 1 were randomized 1:1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with chemotherapy (two cycles) or chemotherapy alone (four cycles). In the phase 3 CheckMate 9LA study, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy alone.

Checkmate 9la brain metastases