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    First-line pembrolizumab plus chemotherapy versus chemotherapy in advanced esophageal cancer: Longer-term efficacy, safety, and quality-oflife results from the phase 3 KEYNOTE-590 study

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    Authors
    Metges, J. P.
    Kato, K.
    Sun, J. M.
    Shah, M. A.
    Enzinger, P. C.
    Adenis, A.
    Doi, T.
    Kojima, T.
    Li, Z. G.
    Kim, S. B.
    Cho, B. C.
    Mansoor, Was
    Li, S. H.
    Sunpaweravong, P.
    Alsina, M.
    Buchschacher, G. L.
    Wu, J. M.
    Shah, S.
    Bhagia, P.
    Shen, L.
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    Affiliation
    CHU Brest–Institut de Cancerologie et d’Hematologie ARPEGO Network, Brest, France;
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Background: At interim analysis of the phase 3, randomized, double-blind KEYNOTE-590 (NCT03189719) study, 1L pembrolizumab (pembro) + chemotherapy (chemo) vs chemo alone provided superior OS, PFS, and ORR with a manageable safety profile in patients (pts) with untreated, advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). We report efficacy, safety, and health-related quality of life (HRQoL) results with an additional 12 months (mo) of follow-up. Methods: 749 eligible pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2 yr + chemo. Randomization was stratified by geographic region, histology, and performance status. Treatment continued until progression, unacceptable toxicity, or withdrawal, or 2 yr. No crossover was permitted. Primary endpoints were OS in pts with ESCC PD-L1 combined positive score (CPS) ≥10 tumors, and OS and PFS (RECIST v1.1; by INV) in ESCC, PD-L1 CPS ≥10, and all pts. Secondary endpoints included ORR, DOR, safety, and HRQoL. HRQol was assessed in 711 treated pts with ≥1 HRQoL assessment (356 pembro + chemo; 355 chemo). Data cutoff was July 9, 2021. Results: At data cutoff, median follow-up (randomization to data cutoff) was 34.8 mo. Median OS was longer with pembro + chemo vs chemo in pts with ESCC CPS ≥10 (HR 0.59; 95% CI, 0.45-0.76), ESCC (HR 0.73; 95% CI, 0.61-0.88), CPS ≥10 (HR 0.64; 95% CI, 0.51-0.80), and all pts (HR 0.73, 95% CI, 0.63-0.86). In pts with adenocarcinoma OS HR was 0.73 (95% CI, 0.55-0.99). The 24-mo OS rate in all pts was 26.3% vs 16.1%. Median PFS was longer with pembro + chemo vs chemo in ESCC (HR 0.65; 95% CI, 0.54-0.78), CPS ≥10 (HR 0.51; 95% CI, 0.41-0.65), and all pts (HR 0.64; 95% CI, 0.55-0.75). The 24-mo PFS rate in all pts was 11.6% vs 3.3%. Confirmed ORR was 45.0% (25 CR [6.7%]) vs 29.3% (9 CR [2.4%]), with median DOR of 8.3 vs 6.0 mo. Approximately 20% vs 6% of pts had response duration ≥24 months. Grade 3-5 drug-related AE rates were 72% vs 68%. Discontinuation rates from drug-related AEs were 21% vs 12%. There was no significant difference in least square mean (LSM) change from baseline to wk 18 between arms in EORTC QLQ-C30 global health status/quality-of-life (LSM difference -0.10; 95% CI, -3.40-3.20). LSM change from baseline to wk 18 was better with pembro + chemo vs chemo for QLQ-OES 18 pain (-2.94; 95% CI, -5.86 to -0.02) and dysphagia (-5.54; 95% CI, -10.92 to -0.16). Conclusions: With an additional 12 months of follow-up, pembro + chemo continued to provide significant and clinically meaningful improvement in OS, PFS, and ORR vs chemo with a manageable safety profile, and stable quality-of-life for pts with untreated, advanced esophageal and EGJ cancer. These data continue to support 1L pembro + chemo as a new standard of care in these patients.
    Citation
    Metges JP, Kato K, Sun JM, Shah MA, Enzinger PC, Adenis A, et al. First-line pembrolizumab plus chemotherapy versus chemotherapy in advanced esophageal cancer: Longer-term efficacy, safety, and quality-of-life results from the phase 3 KEYNOTE-590 study.. Vol. 40, Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2022. p. 241–241.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/625239
    DOI
    10.1200/JCO.2022.40.4_suppl.241
    Additional Links
    https://dx.doi.org/10.1200/JCO.2022.40.4_suppl.241
    Type
    Meetings and Proceedings
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2022.40.4_suppl.241
    Scopus Count
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