國家衛生研究院 NHRI:Item 3990099045/11828
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    題名: M7824 (MSB0011359C), a bifunctional fusion protein targeting PD-L1 and TGF-beta, in Asian patients with pretreated biliary tract cancer: Preliminary results from a phase I trial
    其他題名: M7824 (MSB0011359C), a bifunctional fusion protein targeting PD-L1 and TGF-β, in Asian patients with pretreated biliary tract cancer: Preliminary results from a phase I trial
    作者: Yoo, C;Oh, DY;Choi, HJ;Kudo, M;Ueno, M;Kondo, S;Chen, LT;Osada, M;Helwig, C;Dussault, I;Ikeda, M
    貢獻者: National Institute of Cancer Research
    摘要: Background: Biliary tract cancers (BTCs) are a group of aggressive cancers with limited treatment options. Overall response rates (ORRs) with 2L chemotherapy in BTC are <10%, and no standard of care exists. M7824 is an innovative first-in-class bifunctional fusion protein composed of a human anti–PD-L1 IgG1 monoclonal antibody fused with 2 extracellular domains of the transforming growth factor β (TGF-β) receptor II (a TGF-β “trap”). We report on the safety and efficacy of M7824 in patients (pts) with pretreated BTC. Methods: In this expansion cohort of the ongoing phase 1, open-label trial NCT02699515, Asian pts who progressed after platinum-based 1L treatment received M7824 1200 mg q2w until confirmed progressive disease, unacceptable toxicity or trial withdrawal. The primary objective is safety/tolerability; secondary objectives include assessment of best overall response per RECIST v1.1. Tumor cell PD-L1 expression was evaluated (antibody clone 73-10). Results: As of March 20, 2018, 30 pts with pretreated BTC received M7824 for a median duration of 8.9 (range, 2-57.6) wk; 5 pts remained on treatment. The most common treatment-related adverse events (TRAEs) were pyrexia, maculopapular rash (both 13.3%) rash and lipase increase (both 10%); 10 pts (33.3%) experienced grade ≥3 TRAEs. 3 deaths due to AEs were reported; 1 death was due to septic shock (bacteremia, etiology unknown) after 14 doses, and 2 deaths due to interstitial lung disease (ILD), 1 on treatment after 3 doses and 1 with grade 3 ILD after 3 doses that recovered, initiated chemotherapy due to PD, and worsened with death 6 months after initial ILD diagnosis and last M7824 dose. 7 pts had an objective response (ORR, 23.3%, including one late PR pending confirmation), with 4 of 6 PRs ongoing (0.7+, 2.8, 3.9+, 5.5+, 5.6, and 6.9+ mo) and 1 CR ongoing for 5.6+ mo. 1 additional pt had ongoing PR for 7.6+ mo after initial pseudoprogression. Confirmed ORR by PD-L1 expression was 25% and 15.4% in pts with PD-L1 + (≥1%) and PD-L1− tumors, respectively. Conclusions: M7824 monotherapy has promising efficacy in Asian pts with pretreated BTC, including long-lasting responses in 8 of 30 pts (27%).
    日期: 2018-10
    關聯: Annals of Oncology. 2018 Oct;29(Suppl. 8):Meeting Abstract 757P.
    Link to: https://doi.org/10.1093/annonc/mdy282.140
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000459277301336
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