Mercadon's "Keytruda and Yervoy" treatment of NSCLC failed
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Last Update: 2021-03-05
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Source: Internet
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Author: User
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announced on November 9th that it would stop clinical trials codenum KEYNOTE-598, a study on the use of Keytruda in association with Yervoy® Therapy) is a first-line treatment for metastasis non-small cell lung cancer (NSCLC) that treats tumor expression PD-L1 (tumor ratio score (TPS) ≥50%) and is free of EGFR or ALC gene mutations compared to Keytruda monodrings.On the recommendation of the Independent Data Monitoring Board (DMC), Mercadon voluntarily terminated the study, which found that the benefit/risk ratio of the combination therapy did not support the continuation of the trial.In the interim analysis, the combined use of "K-Y" did not increase patient benefits in terms of total lifetime (OS) or progress-free lifetime (PFS) (the double primary endpoint of this study) compared to Keytruda alone, and crossed invalid boundaries.No new adverse reaction events were observed in single-drug therapy, but there was a higher risk of class 3-5 adverse events (AEs), severe AEs, and AEs leading to drug suspension or death than Keytruda single-drug use.The original idea of the KEYNOTE-598 clinical trial was to explore whether the combined use of the anti-PD-1 treatment drug Keytruda and ipilimumab provided benefits other than the sole use of Keytruda in metastasis non-small cell lung cancer, but in this study, the addition of ipilimumab did not increase clinical benefits, but instead increased drug toxicity.Currently, there are approved combination therapies for anti-PD-1 therapy combined with ipilimumab in some adaptations, but studies supporting these approvals do not directly compare anti-PD-1 therapy with anti-PD-1 monotherapy in most cases, for example, the clinical trials of the first-line treatment NSCLC approved by the European Union are conducted in contrast to chemotherapy. Related reading: The first-line treatment NSCLC for the first-line treatment of the "Opdivo-Yervoy" is approved by the European Unionhowever, according to the Keytruda-related treatment package published by Mercado, the Lung Program is evaluating keytruda's role in various stages of the disease and treatment options in more than 200 clinical trials for tens of thousands of patients.KEYNOTE-598 (ClinicalTrials.gov, NCT03302234) is a randomized, double-blind, Phase III clinical trial that compared Keytruda combined ipilimumab to Keytruda monotherapy, with first-line therapy metastasis without EGFR or ALC gene mutations and PD-L1 (TPS≥50%) expressed in NSCLC patients.The clinical two main endpoints of the study were OS and PFS, and the secondary clinical endpoints included objective mitigation rates, mitigation duration and safety. The study recruited 568 patients and treated them at random (1:1): Keytruda (200 mg per 3 weeks on the first day of the cycle, up to 35 cycles) and ipilimumab (1 mg/kg per 6 weeks for the first day of the cycle, up to 18 cycles);Keytruda (200 mg per 3 weeks on the first day of the cycle, up to 35 cycles) and placebo (intravenous injections every 6 weeks for the first day of the cycle, up to 18 cycles). (Sina Pharmaceutical News): Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA® (pembrolizumab) In With Ipiliumab Versus KEYTRUDA
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