The safety profile of KEYTRUDA in this study was consistent with that observed in previously reported studies.
KEYNOTE 590 TRIAL
The trial will continue to evaluate DFS in patients whose tumors express high levels of PD-L1 (TPS ≥50%) and OS. Additionally, a favorable trend in overall survival (OS), a key secondary endpoint, was observed for KEYTRUDA versus placebo regardless of PD-L1 expression (HR=0.87 p=0.17) these OS data are not mature and did not reach statistical significance at the time of this interim analysis. Among these patients, median DFS was not reached in either arm. We thank the patients, their caregivers and investigators for participating in this study.”Īs previously announced, there was also an improvement in DFS for patients whose tumors express PD-L1 (tumor proportion score ≥50%) treated with KEYTRUDA compared to placebo, the other dual primary endpoint these results did not reach statistical significance per the pre-specified statistical plan (HR=0.82 p=0.14). “KEYTRUDA has become foundational in the treatment of metastatic non-small cell lung cancer, and we are pleased to present these data showing the potential of KEYTRUDA to help more patients with lung cancer in earlier stages of disease. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD. “These are the first positive results for KEYTRUDA in the adjuvant setting for non-small cell lung cancer, and represent the sixth positive pivotal study evaluating a KEYTRUDA-based regimen in earlier stages of cancer,” said Dr. These data are being presented today during a European Society for Medical Oncology (ESMO) Virtual Plenary and will be shared with regulatory authorities worldwide.
Median DFS was 53.6 months for KEYTRUDA versus 42.0 months for placebo, an improvement of nearly one year. The study found that adjuvant treatment with KEYTRUDA significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo (hazard ratio =0.76 p=0.0014) in patients with stage IB (≥4 centimeters) to IIIA non-small cell lung cancer (NSCLC) following surgical resection regardless of PD-L1 expression. 17, 2022 – MSD, a trade name of Merck & Co., Inc, Kenilworth, NJ, USA., the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. First Phase 3 Study to Demonstrate Statistically Significant Improvement in DFS in the Adjuvant Setting for Patients With Stage IB-IIIA NSCLC Regardless Of PD-L1 ExpressionīRUSSELS KENILWORTH, N.J., Mar.
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