PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer.

Huddart R., Siefker-Radtke A., Balar A., Bilen M., Powles T., Bamias A., ...Daha Fazla

Future oncology (London, England), cilt.17, ss.137-149, 2020 (SCI-Expanded, Scopus) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 17
  • Basım Tarihi: 2020
  • Doi Numarası: 10.2217/fon-2020-0795
  • Dergi Adı: Future oncology (London, England)
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CINAHL, EMBASE, MEDLINE
  • Sayfa Sayıları: ss.137-149
  • Anahtar Kelimeler: bempegaldesleukin, cisplatin-ineligible, IL-2 pathway, immune checkpoint inhibitor combinations, immunotherapy, metastatic urothelial cancer, nivolumab, NKTR-214, PD-L1, PD-L1 negative, SINGLE-ARM, CHEMOTHERAPY, TRIAL, PEMBROLIZUMAB, MULTICENTER, ATEZOLIZUMAB, CARCINOMA, EFFICACY, NKTR-214, UNFIT
  • İstanbul Üniversitesi-Cerrahpaşa Adresli: Hayır

Özet

The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and -negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).