53P Toripalimab with chemotherapy as first-line treatment for advanced biliary tract tumors: A preliminary analysis of safety and efficacy of an open-label phase II clinical study

Liu, T.; Li, W.; Yu, Ya‐Hui; Guo, Xing; Xu, Xiao‐Quan; Wang, Y.; Li, Q.; Cui, Yue; Liu, H.; Zhang, S.; Wang, F.; Yao, Michael; Zhang, L.

doi:10.1016/j.annonc.2020.08.031

Cited by 13 publications

(11 citation statements)

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“…In the phase II trial NCT03796429, treatment-naive patients with advanced BTC received toripalimab combined with gemcitabine and S-1 until progressive disease or unacceptable toxicity. By the data cutoff at January 24, 2021, the ORR was 27.1% (13/48) and DCR was 87.5% (42/48), median PFS was 7.0 months and median OS was 16.0 ( 92 , 93 ). In a similar phase I study JapicCTI-153098, 30 chemotherapy-naive Japanese patients with unresectable or recurrent BTC were given nivolumab and cisplatin plus gemcitabine chemotherapy; in this cohort, median OS was 15.4 months, median PFS was 4.2 months, and 11 of 30 patients (36.7%) had an objective response ( 94 ).…”

Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 97%

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

et al. 2022

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Toripalimab (Tuoyi™) is a selective, recombinant, humanized monoclonal antibody against programmed death protein 1 (PD-1) developed by Shanghai Junshi Bioscience Co., Ltd. Toripalimab is able to bind to PD-1 and block the interaction with its ligands. The binding of toripalimab to PD-1 is mainly attributed to the heavy chain of the former and the FG loop of the latter. Toripalimab received a conditional approval in China for the treatment of melanoma (second-line) in December, 2018. It has also received approvals to treat nasopharyngeal carcinoma (first-line and third-line) and urothelial carcinoma (second-line) in 2021. Additionally, several orphan drug designations were granted to toripalimab by the US Food and Drug Administration. Toripalimab has exhibited primary anti-tumor effects in tumors such as melanoma, lung cancer, digestive tract tumors, hepatobiliary and pancreatic tumors, neuroendocrine neoplasms, nasopharyngeal carcinoma and urothelial carcinoma. It showed a satisfactory anti-tumor effect and long-term survival benefits in Chinese melanoma patients, while the combination of axitinib with toripalimab exhibited an impressive result in metastatic mucosal melanoma. As a checkpoint inhibitor, toripalimab was generally well-tolerated in the enrolled patients. Due to different study populations, comparisons could not be made directly between toripalimab and other drugs in most cases. Nevertheless, the introduction of toripalimab may offer a valuable choice for decision-making in the treatment of tumors in the future.

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Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 97%

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

et al. 2022

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“…CR and PR were reported in 22 studies ( 31 – 43 , 46 , 48 , 50 , 51 , 53 – 56 , 60 ), while SD was reported in 27 studies ( 31 – 43 , 46 – 48 , 50 – 60 ). The pooled CR, PR, and SD in total and by medication regimen subgroup are recorded in Table 3 .…”

Section: Resultsmentioning

confidence: 99%

“…Thirteen studies consisted of 11 prospective studies (31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41) and 2 retrospective studies (42,43), which were assessed by the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) (44) and the JBI critical appraisal tool for case series (45), respectively. There were 14 studies [1 randomized study (46), 2 non-randomized comparative studies (47,48), 10 single-arm studies (49)(50)(51)(52)(53)(54)(55)(56)(57)(58), and 1 retrospective study (59)] with no full text available, which is why we gave up the corresponding quality assessments. What is more, we also did not assess the quality of one study reporting safety run-in results of a randomized, two-arm, non-comparative trial (60) due to the paucity of validated evaluation tools designed for this kind of trial.…”

Section: Quality Assessmentmentioning

confidence: 99%

“…In 28 studies reporting ORR (31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60), the pooled ORR was 19.3%. The pooled ORRs of anti-PD1/PDL1 monotherapy, anti-PD1/PDL1 plus antiangiogenesis, anti-PD1/PDL1 plus anti-CTLA4, anti-PD1/PDL1 plus chemotherapy, and anti-PD1/PDL1 combined with anti-CTLA4 and chemotherapy were 6.8%, 17.5%, 9.9%, 36.3%, and 45.1% respectively, (Figure 4A).…”

Section: Anti-pd1/pdl1 Monotherapy or In Combination With Other Thera...mentioning

confidence: 99%

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Efficacy and Safety of Anti-PD1/PDL1 in Advanced Biliary Tract Cancer: A Systematic Review and Meta-Analysis

et al. 2022

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BackgroundAnti-programmed cell death protein 1 and its ligand (anti-PD1/PDL1) have been proposed as a promising therapeutic option for advanced biliary tract cancer (aBTC). Given the scarce quantitative analyses of anti-PD1/PDL1 in aBTC, we thus did a meta-analysis to assess the benefits and risks of this emerging treatment strategy in patients with aBTC.MethodsPubMed, Embase, the Cochrane Library, Web of Science, and meeting resources were searched for relevant studies. The main endpoints were median progression-free survival (mPFS), median overall survival (mOS), objective response rate (ORR), disease control rate (DCR), any-grade adverse events (AEs), and grade 3–4 AEs.ResultsTwenty-eight studies with 1,338 participants were included. The best curative effect was found in the anti-PD1/PDL1 combined with anti-CTLA4 and chemotherapy group (mPFS: 12.4 months; mOS: 16.0 months; ORR: 45.1%; DCR: 95.0%), followed by the anti-PD1/PDL1 plus chemotherapy group (mPFS: 8.2 months; mOS: 14.8 months; ORR: 36.3%; DCR: 84.6%), the anti-PD1/PDL1 plus antiangiogenesis group (mPFS: 4.9 months; mOS: 10.2 months; ORR: 17.5%; DCR: 68.7%), the anti-PD1/PDL1 plus anti-cytotoxic T lymphocyte antigen 4 (anti-CTLA4) group (mPFS: 2.9 months; mOS: 8.3 months; ORR: 9.9%; DCR: 36.8%), and the anti-PD1/PDL1 monotherapy group (mPFS: 2.5 months; mOS: 7.6 months; ORR: 6.8%; DCR: 34.7%). Compared with anti-PD1-containing regimens, anti-PDL1-containing regimens achieved preferable mPFS (11.1 vs. 3.8 months), mOS (12.2 vs. 9.8 months), and ORR (23.7% vs. 17.4%), despite a similar DCR (61.1% vs. 61.3%). The mPFS, mOS, ORR, and DCR were 10.6 months, 15.8 months, 42.3%, and 88.6% of first-line anti-PD1/PDL1 and 3.0 months, 9.1 months, 11.6%, and 51.1% of second-line therapy or beyond, respectively. There were 80.6% and 34.0% of the patients suffering any-grade AEs and grade 3–4 AEs. Anti-PD1/PDL1 monotherapy might be considered as a safer alternative than combination regimens. Meanwhile, obvious toxicities in the first-line setting could not be neglected.ConclusionsAnti-PD1/PDL1 showed encouraging efficacy and acceptable safety profile in aBTC and, thus, could be an alternative treatment.

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“…Toripalimab, an anti-PD-1 antibody, was combined to gemcitabine and the oral fluoropyrimidine S-1 in a phase 2 study of 39 patients with advanced BTCs [ 63 ]. Of 34 evaluable patients, ORR was 20.6% and DCR was 85.3%.…”

Section: Current Results Of Immune Therapies In Biliary Tract Cancmentioning

confidence: 99%

Immunotherapy in Advanced Biliary Tract Cancers

Boilève

Hilmi²,

Smolenschi

et al. 2021

Cancers

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Biliary tract cancers are rare tumors with a poor prognosis. Two-thirds of these primary liver malignancies are diagnosed at advanced stages where therapeutic options are limited. Whereas several molecular targeted therapies emerge in biliary tract cancers, immunotherapy is still investigational, the only approved immunotherapy to date being the immune checkpoint inhibitor pembrolizumab for the small fraction of patients with microsatellite-instable tumors. In microsatellite-stable, pre-treated biliary tract cancers, single-agent immune checkpoint blockade has a limited albeit often long-lasting clinical activity in a still ill-defined subgroup of patients. The identification of predictive biomarkers will allow a better selection of patients that may benefit from immunotherapy. Combinations of immunotherapies with each other, with chemotherapy or targeted molecular therapies are being investigated in early lines of therapy, including first-line.

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53P Toripalimab with chemotherapy as first-line treatment for advanced biliary tract tumors: A preliminary analysis of safety and efficacy of an open-label phase II clinical study

Cited by 13 publications

References 0 publications

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

Efficacy and Safety of Anti-PD1/PDL1 in Advanced Biliary Tract Cancer: A Systematic Review and Meta-Analysis

Immunotherapy in Advanced Biliary Tract Cancers

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