{"entity":{"id":"jupiter-02","kind":"trial","name":"JUPITER-02","aka":[],"tldr":"Brought immunotherapy to nasopharyngeal cancer, an Epstein-Barr-virus-driven cancer common in southern China, and won the first US approval for that disease.","summary":"JUPITER-02, trial NCT03581786 sponsored by Junshi and Coherus and reported in 2021, brought immunotherapy to nasopharyngeal carcinoma, an Epstein-Barr-virus-driven cancer common in southern China, and won the first US approval for that disease. It randomised 289 patients with untreated recurrent or metastatic disease to toripalimab or placebo with gemcitabine and cisplatin, met its primary progression-free survival endpoint with a large effect, and confirmed an overall survival benefit with six-year follow-up showing sustained separation, leading to FDA approval on 27 October 2023 and EU approval after. OnCo links it to head and neck cancer, PD-1 as a target, toripalimab, Sun Yat-sen University Cancer Center, Jun Ma and Shanghai Junshi Biosciences. Whether plasma EBV DNA can guide who needs the immunotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03581786","url":"https://clinicaltrials.gov/study/NCT03581786"},{"label":"6-year update, OncLive","url":"https://www.onclive.com/view/toripalimab-plus-chemo-maintains-survival-benefit-after-6-years-in-recurrent-metastatic-npc"}],"tags":[],"related":[],"cancers":["head-and-neck","nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["toripalimab"],"companies":["junshi","coherus"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":["captain-1st"],"people":["ma-jun"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03581786","phase":"3","setting":"Untreated recurrent or metastatic nasopharyngeal carcinoma: toripalimab + gemcitabine-cisplatin vs chemotherapy","sponsor":"Junshi / Coherus","result":"PFS HR 0.52; OS HR 0.63.","started":"2018-10-18","startedType":"actual","yearReported":2021,"enrolled":289,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Toripalimab + chemotherapy"},{"name":"Chemotherapy"}],"hr":0.52,"source":"https://www.onclive.com/view/toripalimab-plus-chemo-maintains-survival-benefit-after-6-years-in-recurrent-metastatic-npc"}],"replication":"CAPTAIN-1st and RATIONALE-309 independently confirmed PD-1 plus chemotherapy in NPC."},"route":"/trials/jupiter-02/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"nasopharyngeal","kind":"cancer","name":"Nasopharyngeal carcinoma","route":"/cancers/nasopharyngeal/"},{"id":"recurrent-metastatic-nasopharyngeal-carcinoma","kind":"cancer","name":"Recurrent and metastatic nasopharyngeal carcinoma","route":"/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"toripalimab","kind":"drug","name":"Toripalimab","route":"/drugs/toripalimab/"}],"company":[{"id":"coherus","kind":"company","name":"Coherus BioSciences","route":"/companies/coherus/"},{"id":"junshi","kind":"company","name":"Shanghai Junshi Biosciences","route":"/companies/junshi/"}],"institution":[{"id":"sysucc","kind":"institution","name":"Sun Yat-sen University Cancer Center","route":"/institutions/sysucc/"}],"trial":[{"id":"captain-1st","kind":"trial","name":"CAPTAIN-1st","route":"/trials/captain-1st/"}],"person":[{"id":"ma-jun","kind":"person","name":"Jun Ma","route":"/people/ma-jun/"}],"paper":[{"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","route":"/key-papers/paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021/"}]}}