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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorRao, S.
dc.contributor.authorAnandappa, G.
dc.contributor.authorCapdevila Castillon, Jaume
dc.contributor.authorDahan, L.
dc.contributor.authorEvesque, L.
dc.contributor.authorKim, S.
dc.date.accessioned2022-09-15T07:07:16Z
dc.date.available2022-09-15T07:07:16Z
dc.date.issued2022-08
dc.identifier.citationRao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529.
dc.identifier.issn2059-7029
dc.identifier.urihttp://hdl.handle.net/11351/8196
dc.descriptionPD-L1 inhibitor; Anal cancer; Retifanlimab
dc.description.abstractBackground Locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) has poor prognosis following platinum-based chemotherapy. Retifanlimab (INCMGA00012), a humanized monoclonal antibody targeting programmed death protein-1 (PD-1), demonstrated clinical activity across a range of solid tumors in clinical trials. We present results from POD1UM-202 (NCT03597295), an open-label, single-arm, multicenter, phase II study evaluating retifanlimab in patients with previously treated advanced or metastatic SCAC. Patients and methods Patients ≥18 years of age had measurable disease and had progressed following, or were ineligible for, platinum-based therapy. Retifanlimab 500 mg was administered intravenously every 4 weeks. The primary endpoint was overall response rate (ORR) by independent central review. Secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results Overall, 94 patients were enrolled. At a median follow-up of 7.1 months (range, 0.9-19.4 months), ORR was 13.8% [95% confidence interval (CI) 7.6% to 22.5%], with one complete response (1.1%) and 12 partial responses (12.8%). Responses were observed regardless of human immunodeficiency virus or human papillomavirus status, programmed death ligand 1 (PD-L1) expression, or liver metastases. Stable disease was observed in 33 patients (35.1%) for a DCR of 48.9% (95% CI 38.5% to 59.5%). Median DOR was 9.5 months (range, 5.6 months-not estimable). Median (95% CI) PFS and OS were 2.3 (1.9-3.6) and 10.1 (7.9-not estimable) months, respectively. Retifanlimab safety in this population was consistent with previous experience for the PD-(L)1 inhibitor class. Conclusions Retifanlimab demonstrated clinically meaningful and durable antitumor activity, and an acceptable safety profile in patients with previously treated locally advanced or metastatic SCAC who have progressed on or are intolerant to platinum-based chemotherapy.
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofseriesESMO Open;7(4)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectAnus - Càncer - Tractament
dc.subjectAnticossos monoclonals - Ús terapèutic
dc.subject.meshAnus Neoplasms
dc.subject.meshCarcinoma, Squamous Cell
dc.subject.meshAntibodies, Monoclonal, Humanized
dc.titleA phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202)
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.esmoop.2022.100529
dc.subject.decsneoplasias del ano
dc.subject.decscarcinoma de células escamosas
dc.subject.decsanticuerpos monoclonales humanizados
dc.relation.publishversionhttps://doi.org/10.1016/j.esmoop.2022.100529
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Rao S, Anandappa G] The Royal Marsden, London, UK. [Capdevila J] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Teknon-IOB, Barcelona, Spain. [Dahan L] Hôpital de la Timone, Marseille, France. [Evesque L] Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France. [Kim S] Centre Hospitalier Régional Universitaire de Besançon, Besançon, France
dc.identifier.pmid35816951
dc.identifier.wos000829876500002
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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