{"entity":{"id":"tusamitamab-ravtansine","kind":"drug","name":"Tusamitamab ravtansine","aka":[],"tldr":"Tusamitamab ravtansine was Sanofi's ADC against the classic CEA tumour marker, stopped for futility in lung cancer in 2023.","summary":"A CEACAM5-directed ADC with a DM4 maytansinoid payload. Phase 3 CARMEN-LC03 (vs docetaxel in CEACAM5-high non-squamous NSCLC) was stopped in December 2023 when an interim analysis showed the PFS endpoint would not be met; OS was not improved. Sanofi discontinued the whole programme.\n\nLesson: a tubulin-inhibitor payload at DAR ~4 with a non-permeable release mechanism could not match the TOP1-payload ADC bar set in lung cancer; CEACAM5 itself remains under study with T-cell engagers.","status":"withdrawn","asOf":"2026-09-06","links":[{"label":"Sanofi press release, CARMEN-LC03 (Dec 2023) (page moved; nearest live section)","url":"https://www.sanofi.com/en/media-room/press-releases/2023/"}],"tags":["failure","lesson:wrong-drug"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["adc"],"targets":["ceacam5"],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04154956","nct04524689","nct04659603"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"SAR408701","modality":"ADC","payload":"DM4 (ravtansine)","linker":"SPDB disulfide","mechanism":"Humanised anti-CEACAM5 IgG1 with DM4 via cleavable SPDB linker.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tusamitamab-ravtansine/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"ceacam5","kind":"target","name":"CEACAM5","route":"/targets/ceacam5/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"trial":[{"id":"nct04154956","kind":"trial","name":"SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients","route":"/trials/nct04154956/"},{"id":"nct04524689","kind":"trial","name":"Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC","route":"/trials/nct04524689/"},{"id":"nct04659603","kind":"trial","name":"Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors","route":"/trials/nct04659603/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"}],"biomarker":[{"id":"ceacam5-expression","kind":"biomarker","name":"CEACAM5 expression","route":"/biomarkers/ceacam5-expression/"}]}}