- #Keynote 189 overall survival update skin
- #Keynote 189 overall survival update full
- #Keynote 189 overall survival update trial
During the 2019 ASCO Annual Meeting, updates to the study were presented, showing a longer follow-up and progression-free survival 2 (PFS2) findings.
#Keynote 189 overall survival update trial
(ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.The phase III KEYNOTE-189 trial led to the FDA approval of the combination of pembrolizumab (Keytruda) plus chemotherapy for the treatment of patients with metastatic nonsquamous nonsmall cell lung cancer (NSCLC) without EGFRor ALKalterations. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc.
#Keynote 189 overall survival update full
For full disclosures of the study authors, visit. Paz-Ares, of Hospital Universitario 12 de Octubre, Madrid, is the corresponding author for The Lancet Oncology article.ĭisclosure: The study was funded by Bristol Myers Squibb. These data support this regimen as a new first-line treatment option for patients with advanced NSCLC.”ĭr. The investigators concluded, “Nivolumab plus ipilimumab with two cycles of chemotherapy provided a significant improvement in overall survival vs chemotherapy alone and had a favorable risk-benefit profile. Treatment-related death occurred in six patients (2%) of the control group, with causes consisting of anemia, febrile neutropenia, pancytopenia, pulmonary sepsis, respiratory failure, and sepsis.
Treatment-related death occurred in seven patients (2%) in the nivolumab/ipilimumab group, with causes consisting of acute kidney failure, diarrhea, hepatotoxicity, hepatitis, pneumonitis, sepsis with acute renal insufficiency, and thrombocytopenia.
#Keynote 189 overall survival update skin
The most common treatment-related grade 3 to 4 immune-mediated adverse events in the nivolumab/ipilimumab group were gastrointestinal (6%), skin (4%), and hepatic (4%) events. Serious treatment-related adverse events of any grade occurred in 30% (25% grade 3–4) vs 18% (15% grade 3–4) of patients, with the most common in the nivolumab/ipilimumab group being diarrhea (3%), febrile neutropenia (3%), and anemia (2%). Grade 3 to 4 treatment-related adverse events occurred in 47% vs 38% of patients, with the most common in the nivolumab/ipilimumab group being neutropenia (7% vs 9% in control group), anemia (6% vs 14%), increased lipase (6% vs 1%), and diarrhea (4% vs 1%). Objective response was observed in 38.2% vs 24.9% of patients (complete response in 2% vs 1%), and median duration of response was 11.3 vs 5.6 months. With longer-term follow up, median progression-free survival was 6.7 months vs 5.0 months (HR = 0.68, 95% CI = 0.57–0.82).
In longer-term follow-up, with a median duration of 13.2 months (IQR = 6.4–17.0 months), median overall survival was 15.6 months (95% CI = 13.9–20.0) in the nivolumab/ipilimumab group vs 10.9 months (95% CI = 9.5–12.6) in the control group (HR = 0.66, 95% CI = 0.55–0.80).
The primary endpoint was overall survival in all randomly assigned patients.Īt the preplanned interim analysis, at a median follow-up of 9.7 months (interquartile range = 6.4–12.8 months), median overall survival was 14.1 months (95% confidence interval = 13.2–16.2 months) in the nivolumab/ipilimumab group vs 10.7 months (95% CI = 9.5–12.4 months) in the control group (hazard ratio = 0.69, 96.71% CI = 0.55–0.87, P =. Treatment with nivolumab/ipilimumab was continued until disease progression (unless prespecified criteria were met for treatment beyond progression), unacceptable toxicity, or for up to 2 years. Chemotherapy consisted of carboplatin at area under the curve (AUC) = 6 plus paclitaxel at 200 mg/m² for patients with squamous histology, or carboplatin at AUC = 5 or 6 plus pemetrexed at 500 mg/m² or cisplatin at 75 mg/m² plus pemetrexed at 500 mg/m² for patients with nonsquamous histology. Treatment consisted of nivolumab at 360 mg every 3 weeks plus ipilimumab at 1 mg/kg every 6 weeks combined with chemotherapy every 3 weeks for two cycles, or chemotherapy alone every 3 weeks for four cycles. Overall, approximately 40% of patients had tumor PD-L1 expression < 1%. In the open-label trial, 719 patients from sites in 19 countries were randomly assigned between August 2017 and January 2019 to receive nivolumab/ipilimumab with two cycles of histology-based platinum doublet chemotherapy (n = 361) or four cycles of chemotherapy alone (control group, n = 358).
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