{"entity":{"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","aka":[],"tldr":"Later report from the ORIENT-11 trial registered as NCT03607539, in Lung cancer (2022); its title describes an updated or longer-term analysis.","summary":"Objectives: In ORIENT-11, first-line sintilimab + pemetrexed-platinum significantly improved PFS compared with placebo + pemetrexed-platinum in patients with advanced metastatic nonsquamous non-small-cell lung cancer (AMnsqNSCLC). The study met the primary endpoint of PFS at 15November2019. Here we report final survival analysis from ORIENT-11 (NCT03607539) using a 15September2021 data cutoff.\n\nMethods: Patients with treatment-naïve locally AMnsqNSCLC without sensitizing EGFR or ALK genomic tumor aberrations were randomly assigned to sintilimab + pemetrexed-platinum (n = 266) or placebo + pemetrexed-platinum (n = 131). Patients were stratified by PD-L1 expression, platinum-chemotherapy, and gender. Treatment continued until PD, unacceptable toxicity, or a maximum of 24 months. Patients in the placebo + pemetrexed-platinum arm could be sequenced to second-line sintilimab monotherapy, contingent upon PD. Response was assessed (RECISTv.1.1) by blinded independent radiographic review committee. Primary endpoint was PFS. OS was a secondary endpoint and defined from date of randomization to date of death due to any cause. Final OS analysis was defined as approximately 2 years after last patient randomized or when approximately 65 % of patients died, whichever first.\n\nResults: At data cutoff of final OS analysis, median study follow-up was 30.8 months. Of 397 patients, 243 OS events were observed (sintilimab + pemetrexed-platinum:151[57 %];placebo + pemetrexed-platinum:92 [70 %]). Of the patients in placebo + pemetrexed-platinum arm, 47 % crossed over to sintilimab monotherapy per protocol. Median OS was 24.2 months in sintilimab + pemetrexed-platinum arm and 16.8 months in placebo + pemetrexed-platinum arm (HR:0.65[95 % CI:0.50,0.85]). Estimated 2-year OS rates were 50 %(sintilimab + pemetrexed-platinum) and 32 %(placebo + pemetrexed-platinum). After adjusting for the crossover effect, OS treatment effect was more pronounced with HR 0.52 (95 % CI:0.38,0.69). OS benefit across all prespecified subgroups was largely consistent with that observed in the ITT population.\n\nConclusions: In the ORIENT-11 final OS analysis, sintilimab + pemetrexed-platinum demonstrated improved OS compared to placebo + pemetrexed-platinum when administered as first-line therapy in AMnsqNSCLC without EGFR or ALK genomic tumor aberrations.\n\nIndexed on Europe PMC as PubMed record 35917647 (DOI 10.1016/j.lungcan.2022.07.013). Its abstract cites the registry id NCT03607539, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Lung Cancer 2022","url":"https://doi.org/10.1016/j.lungcan.2022.07.013"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/35917647/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/35917647"},{"label":"ClinicalTrials.gov NCT03607539","url":"https://clinicaltrials.gov/study/NCT03607539"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["orient-11"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lung-cancer-journal"],"dependsOn":[],"notes":[],"journal":"Lung cancer","year":2022,"doi":"10.1016/j.lungcan.2022.07.013","pmid":"35917647","authors":"Zhang L, Wang Z, Fang J, et al.","paperType":"rct","findings":[],"whatItMeans":"A second publication from the ORIENT-11 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper."]},"route":"/key-papers/paper-orient-11-lung-cancer-2022-update/","neighbours":{"trial":[{"id":"orient-11","kind":"trial","name":"ORIENT-11","route":"/trials/orient-11/"}],"journal":[{"id":"lung-cancer-journal","kind":"journal","name":"Lung cancer","route":"/journals/lung-cancer-journal/"}]}}