The first-line treatment of non-small cell lung cancer by the "Keytruda-Yervoy" therapy in Mesadong failed

Mercadon announced on November 9th that it would stop clinical trials codenum KEYNOTE-598, a study on the use of Keytruda in combination with Yervoy® ("K-Y" dual immunotherapy) A first-line treatment for tumor expression PD-L1 (TPS≥50%) and metastasis non-small cell lung cancer (NSCLC) without 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, compared to Keytruda's alone use, the combined use of "K-Y" did not increase patient benefits in terms of total lifetime (OS) or progress-free lifetime (PFS), the dual primary endpoint of the study, and crossed invalid boundaries.
no new adverse reaction events were observed in single-drug therapy, the 3-5 adverse events (AEs), severe AEs, and AEs that led to drug suspension or death were higher than those used in the keytruda monodration.
KEYNOTE-598 clinical trial was originally conceived 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 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, best-in-a-nation clinical trials of the "O-Y" first-line treatment NSCLC, which were recently approved by the European Union.
: The first-line treatment NSCLC for the "Opdivo-Yervoy" therapy has been approved by the European Union, however, according to the Keytruda-related treatment programme published by Mercado, the Lung Program is evaluating the role of Keytruda 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 with Keytruda single-drug therapy in patients with first-line therapeutic metastasis without EGFR or ALC gene mutations and PD-L1 (TPS≥50%) expressions in NSCLC patients.
the clinical two main endpoints of the study were OS and PFS, and the secondary clinical endpoints included objective remission rates, mitigation duration and safety.
the study recruited a total of 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 intravenously for up to 35 cycles on the first day of the cycle every 3 weeks) and placebo (intravenously for up to 18 cycles on the first day of the cycle every 6 weeks).
source: Merck Announcs KEYNOTE-598 Trial Evaluating KEYTRUDA® (pembrolizumab) in Group With Ipiliumab Versus KEYTRUDA