{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T20:26:01Z","timestamp":1792700761173,"version":"4.5.0"},"reference-count":12,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,3,24]],"date-time":"2021-03-24T00:00:00Z","timestamp":1616544000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2021,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Interleukin (IL)\u201010 has anti\u2010inflammatory and CD8+ T\u2010cell\u2010stimulating properties. Pegilodecakin (pegylated recombinant human IL\u201010) induces intratumoral antigen\u2010specific CD8\u2009+\u2009T\u2010cells and upregulates IFN\u03b3 and major histocompatibility complexes (MHC) I and II. Pegilodecakin has single\u2010agent activity with manageable toxicity in advanced renal cell carcinama (aRCC) (data cutoff 24 March 2016). Pegilodecakin with pembrolizumab or nivolumab revealed clinical activity in aRCC (data cutoff 1 July 2018). Here, we report for the first time the results of pegilodecakin+ pazopanib, and final results for monotherapy and long\u2010term follow\u2010up with pegilodecakin + anti\u2010programmed cell death 1 (anti\u2010PD\u20101) inhibitors (data cutoff 19 February 2019). Phase 1\/1b multi\u2010cohort dose escalation IVY study enrolled 353 patients. Sixty\u2010six patients with aRCC were treated with pegilodecakin alone or with pazopanib or anti\u2010PD\u20101 inhibitor in cohorts A, G, H and I (data cutoff 19 February 2019). Primary endpoints included safety and tolerability. Secondary endpoint was tumor response by immune\u2010related response criteria (irRC). Pegilodecakin plus nivolumab or pembrolizumab yielded median progression\u2010free survival (mPFS) of 13.9\u00a0months and 6\u2010month PFS probability of 60%, 76% 1\u2010year overall survival (OS) probability and 61% 2\u2010year OS probability. Pegilodecakin monotherapy produced mPFS of 1.8\u00a0months, 6\u2010month PFS probability 25%, 1\u2010year OS 50%, and 2\u2010year OS 17%. Median OS was not reached in both combinations. Objective response rates (ORRs) were 33% with pazopanib and 43% with anti\u2010PD\u20101. Most common Grade 3\/4 treatment\u2010related adverse events included anemia, thrombocytopenia and hypertriglyceridemia. In these heavily pretreated renal cell carcinama cohorts of IVY, pegilodecakin+anti\u2010PD\u20101 inhibitor showed promising clinical activity. Safety profile of pegilodecakin alone and with anti\u2010PD\u20101 inhibitors was consistent as previously reported.<\/jats:p>","DOI":"10.1002\/ijc.33556","type":"journal-article","created":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T08:52:00Z","timestamp":1615539120000},"page":"403-408","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Pegilodecakin as monotherapy or in combination with <scp>anti\u2010PD<\/scp>\u20101 or tyrosine kinase inhibitor in heavily pretreated patients with advanced renal cell carcinoma: Final results of cohorts <scp>A, G, H<\/scp> and <scp>I<\/scp> of <scp>IVY Phase I<\/scp> study"],"prefix":"10.1002","volume":"149","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5559-8060","authenticated-orcid":false,"given":"Nizar M.","family":"Tannir","sequence":"first","affiliation":[{"name":"Department of Genitourinary Medical Oncology, Division of Cancer Medicine MD Anderson Cancer Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyriakos P.","family":"Papadopoulos","sequence":"additional","affiliation":[{"name":"START Center for Cancer Care  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah J.","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California Los Angeles (UCLA)  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raid","family":"Aljumaily","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Section of Hematology and Oncology Stephenson Cancer Center of the University of Oklahoma and Sarah Cannon Research Institute  Oklahoma City Oklahoma USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annie","family":"Hung","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Afable","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong Seok","family":"Kim","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Ferry","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Drakaki","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California Los Angeles (UCLA)  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna","family":"Bendell","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute\/Tennessee Oncology  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aung","family":"Naing","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, Division of Cancer Medicine MD Anderson Cancer Center  Houston Texas 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