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http://ir.nhri.org.tw/handle/3990099045/11770
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| Title: | M7824 (MSB0011359C), a bifunctional fusion protein targeting transforming growth factor beta (TGF-beta) and PD-L1, in Asian patients with pretreated biliary tract cancer (BTC): Efficacy by BTC subtype |
| Other Titles: | M7824 (MSB0011359C), a bifunctional fusion protein targeting transforming growth factor β (TGF-β) and PD-L1, in Asian patients with pretreated biliary tract cancer (BTC): Efficacy by BTC subtype |
| Authors: | Yoo, C;Oh, DY;Choi, HJ;Kudo, M;Ueno, M;Kondo, S;Chen, LT;Osada, M;Helwig, C;Dussault, I;Ikeda, M |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: BTCs are a group of cancers with poor prognosis and few treatment options, encompassing intrahepatic (IHCC) and extrahepatic (EHCC) cholangiocarcinomas, gallbladder carcinoma (GC), and ampullary carcinoma (AC). For 2L chemotherapy, no standard of care exists, and overall response rates (ORRs) are <10%. M7824 is an innovative first-in-class bifunctional fusion protein composed of 2 extracellular domains of TGF-β receptor II (a TGF-β “trap”) fused to a human IgG1 mAb against PD-L1. We report the safety and efficacy of M7824 in Asian patients (pts) with pretreated BTC. Methods: Pts who progressed after ≥1 line of chemotherapy receive M7824 1200 mg q2w until disease progression, unacceptable toxicity, or trial withdrawal in this expansion cohort of the ongoing phase 1, open-label trial NCT02699515. The primary objective is safety/tolerability; secondary objectives include best overall response per RECIST v1.1. Results: At 39 wk median follow-up, 30 pts received M7824 for a median of 8.9 (range, 2.0–57.6) wk; 5 pts were on active treatment. Treatment-related adverse events (TRAEs) occurred in 60% of pts; most common were maculopapular rash and pyrexia (13.3% each), as well as lipase increase and rash (10.0% each). 10 pts (33.3%) experienced grade ≥3 TRAEs, including 3 grade 5 (1 septic shock [bacteremia, unknown etiology; 249 and 14 days after first and last dose, resp.], 2 due to interstitial lung disease [ILD; 1 on treatment post 3 doses, 1 after 6 mo of initial ILD diagnosis and last dose). Objective responses were observed in 7 pts (ORR, 23.3%; IHCC, 4/10 pts; EHCC, 1/7 pts; GC, 2/12 pts; AC, 0/1 pts), with 1 durable complete response (5.6+ mo) and 4/6 partial responses (PRs) ongoing at data cutoff (0.7+, 2.8, 3.9+, 5.5+, 5.6, and 6.9+ mo). 1 additional pt with GC had an ongoing PR for 7.6+ mo after initial pseudoprogression. Conclusions: M7824 monotherapy has an acceptable safety profile and promising efficacy in Asian pts with pretreated BTC, with durable responses in 8/30 pts (27%; includes 1 pt with pseudoprogression) across BTC subtypes, including responses in pts with IHCC, EHCC, and GC (ORRs, 40%, 14%, and 17%, resp.). |
| Date: | 2018-11 |
| Relation: | Annals of Oncology. 2018 Nov;29(Suppl. 9):Meeting Abstract 153O. |
| Link to: | https://doi.org/10.1093/annonc/mdy432.005 |
| 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:000458082200199 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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| ISI000458082200199.pdf | | 97Kb | Adobe PDF | 240 | View/Open |
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