2021
DOI: 10.1016/j.annonc.2021.08.2089
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LBA16 KEYNOTE-355: Final results from a randomized, double-blind phase III study of first-line pembrolizumab + chemotherapy vs placebo + chemotherapy for metastatic TNBC

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Cited by 44 publications
(33 citation statements)
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“…Additionally, more patients in IMpassion131 had received prior taxanes than those in IMpassion130, whereas more patients in IMpassion130 had de novo metastatic disease than those in IMpassion131 ( 18 , 61 ). Although exposure to steroids had been considered a potential confounding factor, the use of steroids in the KEYNOTE-355 trial described below makes this unlikely ( 17 , 19 ).…”
Section: Immunotherapy In Breast Cancermentioning
confidence: 99%
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“…Additionally, more patients in IMpassion131 had received prior taxanes than those in IMpassion130, whereas more patients in IMpassion130 had de novo metastatic disease than those in IMpassion131 ( 18 , 61 ). Although exposure to steroids had been considered a potential confounding factor, the use of steroids in the KEYNOTE-355 trial described below makes this unlikely ( 17 , 19 ).…”
Section: Immunotherapy In Breast Cancermentioning
confidence: 99%
“…The success of this phase III trial resulted in the full regulatory approval of pembrolizumab in combination with chemotherapy in patients with PD-L1-positive TNBC, defined as a combined positive score (CPS) ≥10, and representing about 38% of patients with metastatic TNBC ( 74 ). Treatment with pembrolizumab compared to placebo resulted in a statistically significant improvement in PFS (9.7 vs 5.6 months, HR 0.65, p=0.0012 and OS (23 vs 16.1 months, HR 0.73, p=0.0093), as well as improving objective response rate (ORR, 53.2% vs 39.8%) and duration of response (19.3 vs 7.3 months) in patients whose tumors expressed PD-L1 (CPS ≥10) ( 17 , 19 ).…”
Section: Immunotherapy In Breast Cancermentioning
confidence: 99%
“…In TNBC, however, chemotherapy combination of Atezolizumab enhanced the antitumor efficacy of Nab-paclitaxel only in patients with PD-L1 expression on tumor-infiltrating immune cells [NCT03371017] ( 26 ). On the other hand, chemotherapy combination of pembrolizumab paclitaxel protein-bound, or paclitaxel, or gemcitabine plus carboplatin also benefit patients with TNBC [NCT02819518] ( 70 ). Above all, tumors that respond to immune checkpoint inhibitors are typically so-called thermal or “hot” tumors with CD8 T cell infiltration, indicating that tumor cells are recognized by the immune system.…”
Section: Combination Therapymentioning
confidence: 99%
“…The phase III IMpassion132 study of gemcitabine plus carboplatin/capecitabine with or without atezolizumab as the first-line therapy of TNBC is ongoing (NCT03371017). In the phase III KEYNOTE-355 study (26,27), pembrolizumab combined with chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine/carboplatin) as the first-line treatment of advanced TNBC mainly benefited patients with ≥10% PD-L1 expression (detected by PD-L1 22C3 pharmDx assay) disease, with a median PFS of 9.7 months in combination group versus 5.6 months in chemotherapy group (HR 0.66, 95% CI 0.50-0.88).With respect to grades 3-5 AEs, 68.1% patients experienced that in the combination group (2 deaths), in contrast with 66.9% in the chemotherapy group (0 death). However, more patients suffered grades 3-4 immune-related AEs and infusion reactions in the immunochemotherapy group (5.5% vs. 0%).…”
Section: Combination Of Immunotherapy and Chemotherapymentioning
confidence: 99%