{"entity":{"id":"orient-11","kind":"trial","name":"ORIENT-11","aka":[],"tldr":"The trial that made sintilimab a first-line lung cancer treatment in China, and the one the FDA later refused to accept as evidence for US patients.","summary":"397 patients randomised 2:1. Median progression-free survival 8.9 versus 5.0 months (hazard ratio 0.482) at the interim analysis, with benefit across PD-L1 subgroups; overall survival later favoured sintilimab. NMPA approval followed in February 2021. Innovent and Lilly filed the same data with the FDA; at a February 2022 advisory committee members voted 14 to 1 that a single-country trial with a chemotherapy-alone comparator did not show applicability to US patients, and a complete response letter followed in March 2022, setting the template for how China-only trials are judged.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03607539","url":"https://clinicaltrials.gov/study/NCT03607539"},{"label":"J Thorac Oncol 2020","url":"https://doi.org/10.1016/j.jtho.2020.07.014"},{"label":"FDA ODAC 10 February 2022 (archived copy)","url":"https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab","pemetrexed"],"companies":["innovent"],"institutions":["nmpa-cde","fda-oce"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-orient-11-j-thorac-oncol-2020","paper-orient-11-lung-cancer-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03607539","phase":"3","setting":"First-line non-squamous NSCLC without EGFR or ALK alterations, China: sintilimab or placebo plus pemetrexed and platinum","sponsor":"Innovent Biologics","result":"PFS 8.9 vs 5.0 months, HR 0.482.","started":"2018-08-23","startedType":"actual","yearReported":2020,"enrolled":397,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sintilimab + pemetrexed-platinum","n":266,"value":8.9},{"name":"Placebo + pemetrexed-platinum","n":131,"value":5}],"hr":0.482,"source":"https://doi.org/10.1016/j.jtho.2020.07.014"}]},"route":"/trials/orient-11/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"},{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"institution":[{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"},{"id":"nmpa-cde","kind":"institution","name":"National Medical Products Administration / Center for Drug Evaluation","route":"/institutions/nmpa-cde/"}],"paper":[{"id":"paper-orient-11-j-thorac-oncol-2020","kind":"paper","name":"Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11)","route":"/key-papers/paper-orient-11-j-thorac-oncol-2020/"},{"id":"paper-orient-11-lung-cancer-2022-update","kind":"paper","name":"Final overall survival data of sintilimab plus pemetrexed and platinum as First-Line treatment for locally advanced or metastatic nonsquamous NSCLC in the Phase 3 ORIENT-11 study","route":"/key-papers/paper-orient-11-lung-cancer-2022-update/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}