2022
Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02
Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. European Urology 2022, 82: 365-373. PMID: 35643589, DOI: 10.1016/j.eururo.2022.05.002.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsMetastatic urothelial carcinomaObjective response rateProgression-free survivalExploratory biomarker analysisOverall survivalUrothelial carcinomaGrade 3/4 treatment-related adverse eventsResponse rateMedian progression-free survivalTreatment-related side effectsCisplatin-ineligible patientsMedian overall survivalPhase 1/2 studyComplete response rateFirst-line treatmentSubset of patientsChemotherapy-free treatmentTumor response assessmentSingle-arm designUnivariate logistic regressionBiomarker analysisMeasurable diseaseMedian durationTreatment landscape
2021
Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma
Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. Journal Of Clinical Oncology 2021, 39: 2914-2925. PMID: 34255535, PMCID: PMC8425826, DOI: 10.1200/jco.21.00675.Peer-Reviewed Original ResearchConceptsProgression-free survivalImmune-mediated adverse eventsMedian progression-free survivalObjective response rateMetastatic melanomaOverall survivalResponse rateAdverse eventsTarget lesionsGrade 3Stage III/IV melanomaEnd pointPhase II cohortComplete response rateMedian overall survivalPrimary end pointRadiologic evidenceUntreated patientsDurable responsesPolyfunctional responsesOS ratesBlood biomarkersComplete clearanceMedian changeExploratory biomarkers