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Sintilimab is Innovent's PD-1 antibody, approved in China since 2018 for Hodgkin lymphoma and then, on the ORIENT trials, for first-line lung, liver, oesophageal and stomach cancer. In 2022 the FDA rejected its lung cancer application because a China-only trial against chemotherapy did not fit US practice, defining the agency's stance on single-country data.
First approved by the NMPA in December 2018 for relapsed or refractory classical Hodgkin lymphoma, then added by the ORIENT programme: first-line non-squamous NSCLC with pemetrexed-platinum (ORIENT-11), squamous NSCLC (ORIENT-12), first-line hepatocellular carcinoma with the bevacizumab biosimilar IBI305 (ORIENT-32), first-line oesophageal squamous cell carcinoma (ORIENT-15) and first-line gastric or gastro-oesophageal junction adenocarcinoma (ORIENT-16). Co-commercialised in China with Eli Lilly. In March 2022 the FDA issued a complete response letter for the ORIENT-11 indication after an advisory committee voted 14 to 1 that a single-country trial with a chemotherapy comparator did not fit US practice, the case that defined the agency's stance on China-only data. Listed on the National Reimbursement Drug List since 2019 after a steep negotiated price cut.
Fully human IgG4 antibody that blocks PD-1 binding to PD-L1 and PD-L2, restoring T-cell activity against the tumour. Connects to PD-1.
1.Sintilimab binds PD-1.
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Complete response letter for ORIENT-11 (first-line non-squamous NSCLC); ODAC voted 14 to 1 that additional data were needed for US applicability source
| Region | Year | Indication |
|---|---|---|
| China | 2018 | Relapsed or refractory classical Hodgkin lymphoma after two or more lines |
| China | 2021 | First-line non-squamous NSCLC with pemetrexed and platinum (ORIENT-11); first-line squamous NSCLC with gemcitabine and platinum (ORIENT-12); first-line unresectable hepatocellular carcinoma with IBI305 (ORIENT-32) |
| China | 2022 | First-line oesophageal squamous cell carcinoma with chemotherapy (ORIENT-15) |
| China | 2023 | First-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapy (ORIENT-16) |
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PD-1 blockade added to chemoradiotherapy is a new option for high-risk locoregionally advanced nasopharyngeal carcinoma; longer follow-up will show whether it lengthens survival.
One trial page and one treatment page on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
One trial page and one treatment page on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
Query for this drug: (TITLE:"Sintilimab" OR ABSTRACT:"Sintilimab" OR TITLE:"Tyvyt" OR ABSTRACT:"Tyvyt" OR TITLE:"IBI308" OR ABSTRACT:"IBI308") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sintilimab, not a curated reading list.
Shares A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal C, A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients, Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer and the tag china.
Shares Michael Yu (Yu De-Chao), Innovent Biologics, Non-small-cell lung cancer and the tag china.
Shares mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer, Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer, Non-small-cell lung cancer and the tag china.
Shares Michael Yu (Yu De-Chao), Innovent Biologics and the tag china.
Shares PD-1 / PD-L1 immune checkpoint & T-cell activation, Monoclonal antibodies, Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
Shares Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Non-small-cell lung cancer and the tag china.
Shares PD-1 / PD-L1 immune checkpoint & T-cell activation, Monoclonal antibodies, Immune checkpoint inhibitors and the tag china.
Shares A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients and the tag china.