{"entity":{"id":"paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021","kind":"paper","name":"JUPITER-02: toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma","aka":[],"tldr":"Adding the PD-1 antibody toripalimab to gemcitabine and cisplatin lengthened the time before metastatic nasopharyngeal cancer progressed by about four months, and later improved survival, making chemo-immunotherapy the first-line standard.","summary":"International randomised double-blind placebo-controlled phase 3 trial of 289 patients with recurrent or metastatic nasopharyngeal carcinoma assigned to toripalimab or placebo with gemcitabine and cisplatin, followed by toripalimab or placebo maintenance.\n\nMedian progression-free survival was 11.7 months with toripalimab against 8.0 months (hazard ratio 0.52) at the interim analysis, with benefit regardless of PD-L1 expression; the final analysis (JAMA 2023) showed improved overall survival. Toripalimab was approved in China in 2021 and by the FDA in 2024.","asOf":"2026-09-18","links":[{"label":"Nat Med 2021","url":"https://doi.org/10.1038/s41591-021-01444-0"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34341578/"}],"tags":[],"related":[],"cancers":["recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["toripalimab","gemcitabine-cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["jupiter-02"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nature-medicine"],"dependsOn":[],"notes":[],"journal":"Nature Medicine","year":2021,"doi":"10.1038/s41591-021-01444-0","pmid":"34341578","authors":"Mai HQ, Chen QY, Chen D, et al.","paperType":"rct","findings":["Median progression-free survival 11.7 months with toripalimab plus chemotherapy versus 8.0 months with chemotherapy alone; hazard ratio 0.52.","Benefit irrespective of PD-L1 status; overall survival improved at final analysis."],"whatItMeans":"PD-1 blockade with gemcitabine and cisplatin is the first-line standard for recurrent or metastatic nasopharyngeal carcinoma, and the first immunotherapy approved for this cancer in the United States.","caveats":["Conducted in mainland China, Taiwan and Singapore; almost all patients had EBV-related non-keratinising disease.","Immune-related adverse events, including hypothyroidism, were more frequent."],"changedPractice":true,"participants":289},"route":"/key-papers/paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021/","neighbours":{"cancer":[{"id":"recurrent-metastatic-nasopharyngeal-carcinoma","kind":"cancer","name":"Recurrent and metastatic nasopharyngeal carcinoma","route":"/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/"}],"drug":[{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"},{"id":"toripalimab","kind":"drug","name":"Toripalimab","route":"/drugs/toripalimab/"}],"trial":[{"id":"jupiter-02","kind":"trial","name":"JUPITER-02","route":"/trials/jupiter-02/"}],"journal":[{"id":"nature-medicine","kind":"journal","name":"Nature Medicine","route":"/journals/nature-medicine/"}]}}