{"entity":{"id":"starglo","kind":"trial","name":"STARGLO","aka":[],"tldr":"A bispecific plus chemotherapy improved survival in relapsed lymphoma, but a US advisory committee voted eight to one that the trial did not apply to American patients, and the second-line use is still not on the US label.","summary":"STARGLO, trial NCT04408638 sponsored by Roche and published in the Lancet in 2024, showed that the CD20 by CD3 bispecific glofitamab with gemcitabine and oxaliplatin improved survival over rituximab plus the same chemotherapy in relapsed or refractory diffuse large B-cell lymphoma in transplant-ineligible patients. It randomised 274 patients, met its primary overall survival endpoint with a large progression benefit, and won EU approval in 2025.\n\nThe United States went the other way, and what is on the public record is this. On 20 May 2025 the Oncologic Drugs Advisory Committee discussed supplemental biologics licence application 761309/S-001 for Columvi, for use with gemcitabine and oxaliplatin in adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not candidates for autologous stem cell transplant. The committee was asked whether the STARGLO population and trial results are applicable to the proposed US patient population and voted No 8, Yes 1, Abstain 0. The FDA's own minutes record the reasons: the limited number of US patients enrolled, inconsistencies between Asian and non-Asian populations, non-adherence to the ICH E17 guidance on multiregional trials, and subgroup analyses showing inferior results in non-Asian patients across overall survival, progression-free survival, response rate and complete response. The glofitamab label effective 25 June 2026 still carries only the accelerated approval after two or more lines, so the second-line indication was not granted. OnCo has previously recorded a complete response letter here, citing a trade publication; the FDA does not routinely publish complete response letters and no primary source for one was found, so the claim has been replaced with what the agency's own documents say. Whether regional heterogeneity reflected biology, practice or chance is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04408638","url":"https://clinicaltrials.gov/study/NCT04408638"},{"label":"FDA Oncologic Drugs Advisory Committee, 20 to 21 May 2025: meeting page","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-20-21-2025-meeting-oncologic-drugs-advisory-committee-05202025"},{"label":"FDA meeting minutes, 20 May 2025 (vote: No 8, Yes 1)","url":"https://www.fda.gov/media/187747/download"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["glofitamab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michael-dickinson"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04408638","phase":"3","setting":"R/R DLBCL, transplant-ineligible, ≥1 prior line: glofitamab + GemOx vs rituximab + GemOx","sponsor":"Roche","result":"Overall survival hazard ratio 0.62. A US advisory committee voted 8 to 1 that the trial was not applicable to the US population, and the second-line indication is absent from the US label.","started":"2021-02-23","startedType":"actual","yearReported":2024,"enrolled":274,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Glofit-GemOx","n":183,"value":25.5},{"name":"R-GemOx","n":91,"value":12.9}],"hr":0.62,"ci":[0.43,0.88],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02565-4/fulltext"}],"replication":"Not replicated; applicability to Western populations rejected by the FDA Oncologic Drugs Advisory Committee on 20 May 2025 by 8 votes to 1."},"route":"/trials/starglo/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"drug":[{"id":"glofitamab","kind":"drug","name":"Glofitamab","route":"/drugs/glofitamab/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"person":[{"id":"michael-dickinson","kind":"person","name":"Michael Dickinson","route":"/people/michael-dickinson/"}],"trial":[{"id":"nct04404283","kind":"trial","name":"Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL","route":"/trials/nct04404283/"},{"id":"epcore-nhl-1","kind":"trial","name":"EPCORE NHL-1","route":"/trials/epcore-nhl-1/"},{"id":"polargo","kind":"trial","name":"POLARGO","route":"/trials/polargo/"}],"term":[{"id":"lymphoma-tx-bispecific-step-up","kind":"term","name":"CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one","route":"/terms/lymphoma-tx-bispecific-step-up/"},{"id":"lymphoma-tx-failed-and-negative","kind":"term","name":"Lymphoma treatments that did not work: the negative trials worth knowing","route":"/terms/lymphoma-tx-failed-and-negative/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"paper":[{"id":"paper-epcore-nhl-1-epcoritamab-jco-2023","kind":"paper","name":"EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T","route":"/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/"},{"id":"paper-glofitamab-dlbcl-lancet-2024","kind":"paper","name":"Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial","route":"/key-papers/paper-glofitamab-dlbcl-lancet-2024/"}]}}