{"entity":{"id":"compassion-16","kind":"trial","name":"COMPASSION-16 / AK104-303","aka":[],"tldr":"A two-headed antibody that blocks two immune brakes at once extended survival in advanced cervical cancer regardless of PD-L1 status.","summary":"COMPASSION-16, also AK104-303, trial NCT04982237 sponsored by Akeso and published in the Lancet in 2024, showed that cadonilimab, a two-headed antibody that blocks PD-1 and CTLA-4 at once, added to first-line platinum and paclitaxel with or without bevacizumab extends survival in persistent, recurrent or metastatic cervical cancer in China regardless of PD-L1 status. It randomised 445 patients and met its primary progression-free and overall survival endpoints with benefit in both PD-L1-positive and PD-L1-negative subgroups, leading to NMPA approval of the first-line combination in 2024. OnCo links it to cervical cancer, bispecific antibodies, PD-1 and CTLA-4 as targets, cadonilimab, bevacizumab and Akeso. It was not approved outside China by 2026, and whether a bispecific offers more than PD-1 blockade alone in PD-L1-negative disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04982237","url":"https://clinicaltrials.gov/study/NCT04982237"},{"label":"Lancet 2024","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["pd1","ctla4"],"drugs":["cadonilimab","bevacizumab","cisplatin","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04982237","phase":"3","setting":"Persistent, recurrent, or metastatic cervical cancer, first line (China): cadonilimab (PD-1×CTLA-4 bispecific) + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab","sponsor":"Akeso","result":"OS HR 0.64; PFS HR 0.62.","started":"2021-08-27","startedType":"actual","yearReported":2024,"enrolled":445,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"HR","arms":[{"name":"Cadonilimab + chemo ± bev","n":222},{"name":"Placebo + chemo ± bev","n":223}],"hr":0.62,"ci":[0.49,0.8],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"},{"endpoint":"Overall survival","primary":true,"unit":"HR","arms":[{"name":"Cadonilimab + chemo ± bev"},{"name":"Placebo + chemo ± bev"}],"hr":0.64,"ci":[0.48,0.86],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"}]},"route":"/trials/compassion-16/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"cadonilimab","kind":"drug","name":"Cadonilimab","route":"/drugs/cadonilimab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"company":[{"id":"akeso","kind":"company","name":"Akeso","route":"/companies/akeso/"}]}}