{"entity":{"id":"bl-b01d1-307","kind":"trial","name":"BL-B01D1-307","aka":[],"tldr":"The first phase 3 win for a bispecific ADC, in triple-negative breast cancer, announced February 2026.","summary":"BL-B01D1-307, trial NCT06382142 sponsored by SystImmune and Bristol Myers Squibb and announced on 26 February 2026, delivered the first phase 3 win for a bispecific antibody-drug conjugate, izalontamab brengitecan, in previously treated locally advanced or metastatic triple-negative breast cancer. It randomised 418 patients in China to the EGFR by HER3 conjugate or chemotherapy and met its primary progression-free survival endpoint by blinded review and its interim overall survival endpoint with statistically significant and clinically meaningful improvements, with full data at ASCO 2026 and a parallel positive phase 3 in oesophageal squamous cell carcinoma. It has not been replicated outside China, and the global first-line IZABRIGHT-Breast01 trial will show whether the result travels, which is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT06382142","url":"https://clinicaltrials.gov/study/NCT06382142"},{"label":"Targeted Oncology report","url":"https://www.targetedonc.com/view/iza-bren-meets-pfs-and-os-end-points-in-phase-3-tnbc-trial"}],"tags":[],"related":["src-targeted-oncology"],"cancers":["tnbc"],"sections":[],"technologies":["bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06382142","phase":"3","setting":"Previously treated locally advanced or metastatic TNBC: izalontamab brengitecan vs chemotherapy","sponsor":"SystImmune / BMS","result":"PFS and OS significantly improved at interim analysis (numbers presented ASCO 2026).","started":"2024-06-21","startedType":"actual","yearReported":2026,"enrolled":418,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","n":207,"value":8.5},{"name":"Chemotherapy (TPC)","n":211,"value":3.1}],"hr":0.29,"ci":[0.22,0.38],"p":"<0.0001","source":"https://www.onclive.com/view/iza-bren-yields-pfs-and-os-benefits-vs-chemo-in-previously-treated-advanced-tnbc"},{"endpoint":"Overall survival (interim, median follow-up 11 months)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":15.9},{"name":"Chemotherapy (TPC)","value":12.5}],"hr":0.6,"ci":[0.42,0.85],"p":"0.0019","source":"https://www.onclive.com/view/iza-bren-yields-pfs-and-os-benefits-vs-chemo-in-previously-treated-advanced-tnbc"},{"endpoint":"Confirmed objective response rate (BICR)","unit":"%","arms":[{"name":"Izalontamab brengitecan","value":51.7},{"name":"Chemotherapy (TPC)","value":20.5}]}],"replication":"Single Chinese phase 3 with an interim OS analysis; a parallel positive phase 3 in oesophageal squamous cell carcinoma supports the drug, and the global IZABRIGHT-Breast01 trial will test the first-line setting. Not yet replicated outside China."},"route":"/trials/bl-b01d1-307/","neighbours":{"collection":[{"id":"src-targeted-oncology","kind":"collection","name":"Targeted Oncology","route":"/collections/src-targeted-oncology/"}],"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"bispecific-adc","kind":"technology","name":"Bispecific ADC","route":"/technologies/bispecific-adc/"}],"drug":[{"id":"izalontamab-brengitecan","kind":"drug","name":"Izalontamab brengitecan","route":"/drugs/izalontamab-brengitecan/"}],"trial":[{"id":"panku-esophagus01","kind":"trial","name":"PANKU-Esophagus01 (BL-B01D1-305)","route":"/trials/panku-esophagus01/"}],"roadmap":[{"id":"adc-generations","kind":"roadmap","name":"ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs","route":"/roadmaps/adc-generations/"},{"id":"tnbc-history","kind":"roadmap","name":"TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line","route":"/roadmaps/tnbc-history/"},{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}]}}