{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T07:25:35Z","timestamp":1792481135802,"version":"4.5.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"23","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,8,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Bempegaldesleukin (BEMPEG) is a pegylated interleukin (IL)-2 cytokine prodrug engineered to provide controlled and sustained activation of the clinically validated IL-2 pathway, with the goal of preferentially activating and expanding effector CD8<jats:sup>+<\/jats:sup> T cells and natural killer cells over immunosuppressive regulator T cells in the tumor microenvironment. The open-label, phase III randomized controlled PIVOT-09 trial investigated the efficacy and safety of BEMPEG plus nivolumab (NIVO) as first-line treatment for advanced\/metastatic clear cell renal cell carcinoma (ccRCC) with intermediate-\/poor-risk disease. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> Patients with previously untreated advanced\/metastatic ccRCC were randomly assigned (1:1) to BEMPEG plus NIVO, or investigator's choice of tyrosine kinase inhibitor (TKI; sunitinib or cabozantinib). Coprimary end points were objective response rate (ORR) by blinded independent central review and overall survival (OS) in patients with International Metastatic RCC Database Consortium (IMDC) intermediate-\/poor-risk disease. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Overall, 623 patients were randomly assigned to BEMPEG plus NIVO (n = 311) or TKI (n = 312; sunitinib n = 225, cabozantinib n = 87), of whom 514 (82.5%) had IMDC intermediate-\/poor-risk disease. In patients with IMDC intermediate-\/poor-risk disease, ORR with BEMPEG plus NIVO versus TKI was 23.0% (95% CI, 18.0 to 28.7) versus 30.6% (95% CI, 25.1 to 36.6; difference, \u20137.7 [95% CI, \u201315.2 to \u20130.2]; P = .0489), and median OS was 29.0 months versus not estimable (hazard ratio, 0.82 [95% CI, 0.61 to 1.10]; P = .192), respectively. More frequent all-grade treatment-related adverse events (TRAEs) with BEMPEG plus NIVO versus TKI included pyrexia (32.6% v 2.0%) and pruritus (31.3% v 8.8%). Grade 3\/4 TRAEs were less frequent with BEMPEG plus NIVO (25.8%) versus TKI (56.5%). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> First-line BEMPEG plus NIVO for advanced\/metastatic ccRCC did not improve efficacy in patients with intermediate-\/poor-risk disease but led to fewer grade 3\/4 TRAEs versus TKI. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.23.02082","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T19:59:33Z","timestamp":1717617573000},"page":"2800-2811","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":31,"title":["Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09)"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct03729245","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5559-8060","authenticated-orcid":false,"given":"Nizar M.","family":"Tannir","sequence":"first","affiliation":[{"name":"The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1187-1384","authenticated-orcid":false,"given":"Maria Nirvana","family":"Formiga","sequence":"additional","affiliation":[{"name":"A.C. 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