{"entity":{"id":"cosibelimab","kind":"drug","name":"Cosibelimab","aka":[],"tldr":"Cosibelimab is a PD-L1 antibody approved in December 2024 for advanced cutaneous squamous cell carcinoma, offering a third immunotherapy choice.","summary":"Cosibelimab is an IgG1 monoclonal antibody against PD-L1 that keeps a functional Fc region, so in addition to blocking the PD-1/PD-L1 checkpoint it can trigger antibody-dependent cellular cytotoxicity against PD-L1-expressing cells. It is used for metastatic or locally advanced cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation. In the pivotal phase 1 expansion cohorts the response rate was 47% in metastatic disease and 48% in locally advanced disease, with durable responses. A December 2023 complete response letter citing third-party manufacturing inspection findings delayed approval, and the FDA approved it in December 2024 as a third immunotherapy option after cemiplimab and pembrolizumab. Sun Pharma acquired Checkpoint Therapeutics in 2025. Whether the ADCC-competent Fc adds clinical benefit over standard PD-1 antibodies has not been tested head to head.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Cosibelimab","links":[{"label":"CK-301-101 metastatic cohort (JITC 2023)","url":"https://doi.org/10.1136/jitc-2023-007637"},{"label":"Unloxcyt label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3"}],"tags":["gap-fill"],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":[],"companies":["checkpoint-therapeutics"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":[],"trials":["ck-301-101","nct04786964"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Unloxcyt","modality":"Anti-PD-L1 monoclonal antibody (IgG1, ADCC-competent)","mechanism":"Blocks PD-L1 while retaining an active Fc for antibody-dependent cellular cytotoxicity against PD-L1-expressing cells.","approvals":[{"region":"US","year":2024,"indication":"Metastatic or locally advanced cutaneous SCC not curable by surgery or radiation"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2023-12","type":"crl","region":"US","note":"Complete response letter citing third-party manufacturing inspection findings"},{"date":"2024-12-13","type":"approval","region":"US","note":"Approved for cSCC"}]},"route":"/drugs/cosibelimab/","neighbours":{"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"company":[{"id":"checkpoint-therapeutics","kind":"company","name":"Checkpoint Therapeutics","route":"/companies/checkpoint-therapeutics/"},{"id":"sun-pharma","kind":"company","name":"Sun Pharmaceutical Industries","route":"/companies/sun-pharma/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"trial":[{"id":"ck-301-101","kind":"trial","name":"CK-301-101","route":"/trials/ck-301-101/"},{"id":"nct04786964","kind":"trial","name":"Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC","route":"/trials/nct04786964/"}],"paper":[{"id":"paper-ck-301-101-jitc-2023","kind":"paper","name":"Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma","route":"/key-papers/paper-ck-301-101-jitc-2023/"}]}}