Sintilimab
Sintilimab is Innovent's PD-1 antibody, one of the most widely used cancer immunotherapies in China, with approvals across lung, liver, oesophageal and stomach cancer that rest on the ORIENT trials.
Overview
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.
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- Mar 2022Complete response letterUS
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
Approvals
| 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) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
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