| Literature DB >> 32938232 |
Robert A Huddart1, Arlene O Siefker-Radtke2, Arjun V Balar3, Mehmet A Bilen4, Thomas Powles5, Aristotelis Bamias6, Daniel Castellano7, Maged F Khalil8, Michiel S Van Der Heijden9, Vadim S Koshkin10, David W Pook11, Mustafa Özgüroğlu12, Linda Santiago13, Bob Zhong13, David Chien13, Wei Lin13, Mary A Tagliaferri13, Yohann Loriot14.
Abstract
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).Entities:
Keywords: IL-2 pathway; NKTR-214; PD-L1; PD-L1 negative; bempegaldesleukin; cisplatin-ineligible; immune checkpoint inhibitor combinations; immunotherapy; metastatic urothelial cancer; nivolumab
Year: 2020 PMID: 32938232 DOI: 10.2217/fon-2020-0795
Source DB: PubMed Journal: Future Oncol ISSN: 1479-6694 Impact factor: 3.404