The survival benefit was even greater among patients with PD-L1 expression on at least 50% of tumor cells.Īn updated analysis – conducted at an additional 18 months’ follow-up – showed that the OS benefit afforded by pembrolizumab was maintained not only in the intention-to-treat population, but also in the subgroups of patients with archival or newly collected specimens.
The co-primary endpoint of PFS did not differ significantly between the pembrolizumab and docetaxel arms in the overall study population, but pembrolizumab-treated participants with high (≥50%) PD-L1 expression did derive a significant PFS benefit relative to those given the taxane (5.0 and 5.2 months for 2 and 10 mg/kg, respectively, vs 4.1 months).As reported in The Lancet in December 2015, median OS was significantly longer with either the 2 or 10 mg/kg dose of pembrolizumab than with docetaxel 75 mg/m 2, all given every 3 weeks (10.4 and 12.7 vs 8.5 months).
Patient population: Previously treated advanced NSCLC with ≥1% PD-L1-positive tumor cells
#Keynote 158 clinical trials.gov update#
Expert comment: 5-year update of KEYNOTE-001.Researcher comment: 5-year KEYNOTE-001 results show long-lasting survival for some advanced NSCLC patients.
Related news story: Prolonged survival possible with pembrolizumab in advanced NSCLC
#Keynote 158 clinical trials.gov trial#
The trial investigators reported 5-year results at the 2019 ASCO Annual Meeting, with simultaneous publication in the Journal of Clinical Oncology, showing OS rates at this timepoint of 23.2% and 15.5% for treatment-naïve and previously treated participants, respectively. Individuals with versus without prior receipt of thoracic radiation had a higher incidence of any (63 vs 40%) and treatment-related (13 vs 1%) pulmonary toxicity, but the safety profile was considered acceptable by the researchers. The association between higher PD-L1 levels and better outcomes was also observed in this analysis, which appeared in The Lancet Respiratory Medicine in March 2019.Ī secondary analysis of the trial – published in The Lancet Oncology in May 2017 – showed significantly better progression-free survival (PFS) and OS for participants who had previously received radiotherapy relative to those who had not. Three-year results from the trial pointed to a durable effect of the agent on OS, with median OS durations of 22.3 and 10.5 months among treatment-naïve and previously treated participants, respectively. Overall survival (OS) data on the treatment-naïve participants of the same trial, published in the Annals of Oncology in April 2017, showed a median OS time of 22.1 months, with greater benefits for those with a PD-L1 tumor proportion score (TPS) of at least 50%. They showed that pembrolizumab given at a dose of 2 or 10 mg/kg every 3 weeks or 10 mg/kg every 2 weeks was well tolerated and had antitumor activity regardless of whether patients had received prior therapy or not. The results of the NSCLC cohort of the KEYNOTE-001 trial were published in The New England Journal of Medicine in May 2015. Patient population: Locally advanced or metastatic NSCLC with PD-L1 positivity Where a trial comprises multiple solid tumor cohorts, we focus on just the NSCLC and SCLC cohorts in this guide. Here we provide a quick guide to the non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) trials sponsored by the drug manufacturer Merck Sharp & Dohme. The PD-1 inhibitor pembrolizumab is being investigated in multiple KEYNOTE trials across different tumor types, either alone or as part of various combinations, leading to a prodigious amount of information.
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