{"entity":{"id":"ascent-04","kind":"trial","name":"ASCENT-04 / KEYNOTE-D19","aka":[],"tldr":"Showed that pairing an ADC with immunotherapy beats chemotherapy plus immunotherapy in first-line PD-L1-positive TNBC.","summary":"FDA reports 443 randomized patients with previously untreated advanced TNBC and PD-L1 CPS at least 10. Sacituzumab govitecan plus pembrolizumab versus chemotherapy plus pembrolizumab improved median PFS, 11.2 versus 7.8 months (HR 0.65, 95% CI 0.51 to 0.84). Overall survival was immature at approval. The June 24, 2026 approval concerns advanced disease, not postoperative recurrence prevention.","status":"positive","asOf":"2026-10-06","links":[{"label":"FDA approval and randomized efficacy results","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"label":"ASCENT-04/KEYNOTE-D19 (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2508959"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":["gilead","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ascent-04-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":["Primary paper (NEJM 2026): 443 patients with CPS 10 or more randomised 1 to 1 to sacituzumab govitecan with pembrolizumab or chemotherapy with pembrolizumab; progression-free survival 11.2 versus 7.8 months (hazard ratio 0.65), response 60 versus 53 percent, duration of response 16.5 versus 9.2 months, discontinuation for adverse events 12 versus 31 percent, deaths from adverse events 3 percent in each arm; overall survival immature. UK sites (registry, 8): NHS Lothian, Beatson Glasgow, Leeds, Barts, Royal Free, Guy's and St Thomas', University College London Hospitals, Nottingham. No NICE appraisal listed on 24 September 2026."],"nct":"NCT05382286","phase":"3","setting":"First-line PD-L1+ (CPS ≥10) metastatic TNBC: sacituzumab govitecan + pembrolizumab vs chemotherapy + pembrolizumab","sponsor":"Gilead / Merck","participation":[{"nct":"NCT05382286","source":"https://clinicaltrials.gov/study/NCT05382286","fetchedAt":"2026-10-07T16:53:41.225Z","studySha256":"0797c1971eaa5eec2f75e9bb6d3e0bc068ef5bc826f0ba1496c50072aacd2ade","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2025-09-18","leadSponsor":"Gilead Sciences","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":443,"enrolmentType":"ACTUAL","siteCount":504,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","Chile","Czechia","France","Germany","Hong Kong","Hungary","Israel","Italy","Japan","Malaysia","Mexico","Netherlands","Poland","Puerto Rico","South Africa","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"FDA reports 443 randomized patients with previously untreated advanced TNBC and PD-L1 CPS at least 10. Sacituzumab govitecan plus pembrolizumab versus chemotherapy plus pembrolizumab improved median PFS, 11.2 versus 7.8 months (HR 0.65, 95% CI 0.51 to 0.84). Overall survival was immature at approval. The June 24, 2026 approval concerns advanced disease, not postoperative recurrence prevention.","started":"2022-07-25","startedType":"actual","yearReported":2025,"enrolled":443,"enrolledBasis":"randomised","enrolledNote":"FDA-reported randomized efficacy population. ClinicalTrials.gov lists 443 participants (actual); registry and FDA populations remain separately attributed.","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan plus pembrolizumab","value":11.2},{"name":"Chemotherapy plus pembrolizumab","value":7.8}],"hr":0.65,"ci":[0.51,0.84],"p":"0.0009","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan plus pembrolizumab","note":"Immature at FDA approval on June 24, 2026."},{"name":"Chemotherapy plus pembrolizumab"}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"endpoint":"Confirmed objective response rate (FDA approval analysis)","unit":"%","arms":[{"name":"Sacituzumab govitecan plus pembrolizumab","value":61,"note":"95% CI 55 to 68"},{"name":"Chemotherapy plus pembrolizumab","value":55,"note":"95% CI 48 to 62"}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"}],"replication":"FDA-supporting advanced-disease randomized trial; postoperative benefit is not established."},"route":"/trials/ascent-04/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"paper":[{"id":"paper-ascent-nejm-2021","kind":"paper","name":"ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer","route":"/key-papers/paper-ascent-nejm-2021/"},{"id":"paper-nccn-breast-cancer-v4-2026-jnccn-2026","kind":"paper","name":"Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology","route":"/key-papers/paper-nccn-breast-cancer-v4-2026-jnccn-2026/"},{"id":"paper-ascent-04-n-engl-j-med-2026","kind":"paper","name":"Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer","route":"/key-papers/paper-ascent-04-n-engl-j-med-2026/"}],"roadmap":[{"id":"adc-generations","kind":"roadmap","name":"ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs","route":"/roadmaps/adc-generations/"},{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"},{"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/"},{"id":"trop2-adc-roadmap","kind":"roadmap","name":"TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET","route":"/roadmaps/trop2-adc-roadmap/"}],"idea":[{"id":"idea-tnbc-brain-metastasis-trials","kind":"idea","name":"Trials that include, and report, brain metastases in triple-negative breast cancer","route":"/ideas/idea-tnbc-brain-metastasis-trials/"},{"id":"idea-trop2-pet-selection","kind":"idea","name":"TROP2 PET to choose and sequence TROP2 ADCs","route":"/ideas/idea-trop2-pet-selection/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}],"trial":[{"id":"ascent","kind":"trial","name":"ASCENT","route":"/trials/ascent/"},{"id":"keynote-355","kind":"trial","name":"KEYNOTE-355","route":"/trials/keynote-355/"}],"pairing":[{"id":"adc-plus-io","kind":"pairing","name":"ADC + checkpoint inhibitor","route":"/pairings/adc-plus-io/"}]}}