Patients were randomly assigned (1:1) to receive 200 mg of intravenous pembrolizumab once every 3 weeks for 35 cycles or investigator's choice of platinum chemotherapy (carboplatin/cisplatin) plus pemetrexed or gemcitabine, or carboplatin plus paclitaxel for 4 to 6 cycles. 11 We report 5-year efficacy and safety outcomes from KEYNOTE-024. In KEYNOTE-001, a single-arm phase Ib study that evaluated pembrolizumab monotherapy in patients with advanced NSCLC, the 5-year OS rate was 29.6% (95% CI, 7.7 to 56.1) among previously untreated patients with PD-L1 TPS of at least 50%. 4įive-year survival is an important landmark in cancer treatment, but until recently there have been limited data with this length of follow-up in patients with metastatic NSCLC, in part because so few patients are alive at 5 years. 10 OS continued to be improved for pembrolizumab versus chemotherapy (HR, 0.63 95% CI, 0.47 to 0.86) in subsequent analyses. 005) with pembrolizumab versus chemotherapy at the second interim analysis. 10 The study demonstrated significantly improved progression-free survival (PFS) (hazard ratio, 0.50 95% CI, 0.37 to 0.68 P <.
#Keynote 042 update trial#
KEYNOTE-024 is a randomized, open-label, phase III trial of pembrolizumab monotherapy versus platinum-based chemotherapy in patients with previously untreated NSCLC with PD-L1 tumor proportion score (TPS) of at least 50% and was, to our knowledge, the first phase III study to show superiority of immunotherapy over platinum-based chemotherapy in the first-line setting. Pembrolizumab continues to provide long-term improved patient outcomes over chemotherapy for patients with metastatic NSCLC with PD-L1 TPS ≥ 50% in the first-line treatment setting. Access to genetic or exploratory biomarker data requires a detailed, hypothesis-driven statistical analysis plan that is collaboratively developed by the requestor and MSD subject matter experts after approval of the statistical analysis plan and execution of a data-sharing agreement, MSD will either perform the proposed analyses and share the results with the requestor or construct biomarker covariates and add them to a file with clinical data that is uploaded to an analysis portal so that the requestor can perform the proposed analyses. If the request is declined, it will be communicated to the investigator. There are circumstances that may prevent MSD from sharing requested data, including country- or region-specific regulations. Data will be made available for request after product approval in the United States and European Union or after product development is discontinued. In line with data privacy legislation, submitters of approved requests must enter into a standard data-sharing agreement with MSD before data access is granted. Feasible requests will be reviewed by a committee of MSD subject matter experts to assess the scientific validity of the request and the qualifications of the requestors. Applications will be promptly assessed for completeness and policy compliance.
The MSD data-sharing website (available at ) outlines the process and requirements for submitting a data request. MSD is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. Merck Sharp & Dohme Corp (MSD), a subsidiary of Merck & Co, Inc, Kenilworth, NJ, is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company's clinical trials for the purpose of conducting legitimate scientific research. Associated Data Data Availability Statement
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