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Phase III KEYNOTE-598 study finds Keytruda + Yervoy inferior to Keytruda monotherapy in NSCLC.- Merck Inc

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Published:31st Jan 2021
Merck Inc announced first-time data from the Phase III KEYNOTE-598 study evaluating Keytruda (pembrolizumab) in combination with Yervoy (ipilimumab) compared with Keytruda monotherapy as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 (tumor proportion score [TPS] at least 50%). Results of the study showed that the addition of ipilimumab to Keytruda did not improve overall survival (OS) or progression-free survival (PFS) but added toxicity compared with Keytruda monotherapy in these patients. The median OS was 21.4 months for patients randomized to Keytruda in combination with ipilimumab versus 21.9 months for those randomized to Keytruda monotherapy (HR=1.08 [95% CI, 0.85-1.37]; p=0.74). Additionally, the median PFS was 8.2 months for patients in the combination arm versus 8.4 months for those in the Keytruda monotherapy arm (HR=1.06 [95% CI, 0.86-1.30]; p=0.72). According to Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories: "The results are clear – the combination did not add clinical benefit but did add toxicity.” These results were presented in the Presidential Symposium at the IASLC 2020 World Conference on Lung Cancer and published in the Journal of Clinical Oncology. As previously announced in Nov. 2020, the study was discontinued due to futility based on the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of Keytruda in combination with ipilimumab did not support continuing the trial. The DMC also advised that patients in the study discontinue treatment with ipilimumab/placebo. See: "Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score at least 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study." Michael Boyer et al. Journal of Clinical Oncology online January 29, 2021 DOI: 10.1200/JCO.20.03579 Journal of Clinical Oncology
Condition: Non Small Cell Lung Cancer
Type: drug

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