医学
胆道癌
内科学
二线疗法
胆道
肿瘤科
相(物质)
化疗
癌症
吉西他滨
有机化学
化学
作者
Changhoon Yoo,Milind Javle,Helena Verdaguer Mata,Filippo de Braud,Jörg Trojan,Jean‐Luc Raoul,Jin Won Kim,Makoto Ueno,Choong‐kun Lee,Susumu Hijioka,Antonio Cubillo,Junji Furuse,Nilofer S. Azad,Masashi Sato,Yulia Vugmeyster,Andreas Machl,Marcis Bajars,John Bridgewater,Do‐Youn Oh,Mitesh J. Borad
出处
期刊:Hepatology
[Lippincott Williams & Wilkins]
日期:2023-03-31
卷期号:78 (3): 758-770
被引量:44
标识
DOI:10.1097/hep.0000000000000365
摘要
Background and Aims: Biliary tract cancers are rare, heterogeneous cancers with poor prognoses. Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-βRII (a TGF-β “trap”) fused to a human IgG1 monoclonal antibody blocking programmed death ligand 1, was evaluated in patients with locally advanced/metastatic chemorefractory biliary tract cancers. Approach and Results: This multicenter, single-arm, open-label, phase 2 study (NCT03833661) enrolled adults with locally advanced or metastatic biliary tract cancer that was intolerant to or had failed first-line systemic platinum-based chemotherapy. Patients received 1200 mg bintrafusp alfa intravenously Q2W. The primary endpoint was confirmed objective response according to Response Evaluation Criteria in Solid Tumors 1.1 assessed by IRC. Secondary endpoints included duration of response, durable response rate, safety, progression-free survival, and overall survival. Between March 2019 and January 2020, 159 patients were enrolled. Median follow-up was 16.1 (range, 0.0–19.3) months; 17 patients (10.7%; 95% CI: 6.4%–16.6%) achieved an objective response. Median duration of response was 10.0 (range, 1.9–15.7) months; 10 patients (6.3%; 95% CI: 3.1%–11.3%) had a durable response (≥6 mo). Median progression-free survival was 1.8 months (95% CI: 1.7–1.8 mo); median overall survival was 7.6 months (95% CI: 5.8–9.7 mo). Overall survival rates were 57.9% (6 mo) and 38.8% (12 mo). Grade ≥3 adverse events occurred in 26.4% of patients, including one treatment-related death (hepatic failure). Frequent grade ≥3 adverse events included anemia (3.8%), pruritus (1.9%), and increased alanine aminotransferase (1.9%). Conclusions: Although this study did not meet its prespecified primary endpoint, bintrafusp alfa demonstrated clinical activity as second-line treatment in this hard-to-treat cancer, with durable responses and a manageable safety profile.
科研通智能强力驱动
Strongly Powered by AbleSci AI