{"entity":{"id":"rinatabart-sesutecan","kind":"drug","name":"Rinatabart sesutecan","aka":[],"tldr":"Rinatabart sesutecan is a next-generation folate-receptor ADC with a topoisomerase payload that responds in both ovarian and endometrial cancer regardless of receptor level.","summary":"Genmab (via ProfoundBio, 2024). RAINFOL-01: ORR 55.6% in ovarian cancer at 120 mg/m² and 50% in heavily pretreated endometrial cancer at 100 mg/m², the latter earning Breakthrough Therapy designation. Phase 3 RAINFOL-02 versus chemotherapy in platinum-resistant ovarian cancer is enrolling. Neutropenia and anaemia are dose-limiting; ocular toxicity is minimal compared with mirvetuximab.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05579366 (RAINFOL-01 (Rina-S))","url":"https://clinicaltrials.gov/study/NCT05579366"}],"tags":[],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["folr1"],"drugs":[],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":["rainfol-01","nct07604766","nct07166094","nct06619236","nct07225270","nct07564141","nct07288177"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"Rina-S, PRO1184","modality":"ADC","payload":"Exatecan (TOP1 inhibitor), DAR 8","linker":"Hydrophilic cleavable (ProfoundBio)","mechanism":"Anti-FRα IgG1 with a hydrophilic linker carrying exatecan; bystander killing extends activity to FRα-low tumours.","approvals":[],"mechanismSteps":["Binds folate receptor alpha on the tumour cell","Internalised and trafficked to lysosomes","Linker cleaved; exatecan released and diffuses to neighbours","Topoisomerase I trapped; replication collapses in dividing cells"],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025","type":"designation","region":"US","note":"Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum","source":"https://www.cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer"}]},"route":"/drugs/rinatabart-sesutecan/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"}],"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/"}],"target":[{"id":"folr1","kind":"target","name":"Folate receptor alpha","route":"/targets/folr1/"}],"company":[{"id":"genmab","kind":"company","name":"Genmab","route":"/companies/genmab/"}],"trial":[{"id":"nct07604766","kind":"trial","name":"An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can","route":"/trials/nct07604766/"},{"id":"rainfol-01","kind":"trial","name":"RAINFOL-01 (Rina-S)","route":"/trials/rainfol-01/"},{"id":"nct07166094","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer","route":"/trials/nct07166094/"},{"id":"nct07288177","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer","route":"/trials/nct07288177/"},{"id":"nct07225270","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Re","route":"/trials/nct07225270/"},{"id":"nct07564141","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or","route":"/trials/nct07564141/"},{"id":"nct06619236","kind":"trial","name":"Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer","route":"/trials/nct06619236/"}],"idea":[{"id":"idea-fra-adc-sequencing-ovarian","kind":"idea","name":"Sequence folate-receptor ADCs by payload class","route":"/ideas/idea-fra-adc-sequencing-ovarian/"}]}}