Addition of Bempegaldesleukin to Nivolumab Does Not Benefit Cisplatin-Ineligible Patients With First-Line Advanced Urothelial Carcinoma
Results from the phase 2 PIVOT-10 trial demonstrated that the addition of bempegaldesleukin, a pegylated interleukin-2 cytokine prodrug, to nivolumab did not improve outcomes for cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma.
“For patients who are ineligible for any platinum-based therapy, consideration of single-agent immunotherapy was recommended,” stated Arlene O. Siefker-Radtke MD, The University of Texas MD Anderson Cancer Center, Houston, Texas, and coauthors. “However, objective response rate (ORR) and overall survival (OS) for patients treated with first-line immune checkpoint inhibitor (ICI) monotherapy remain low, especially in patients with programmed death ligand-1 (PD-L1)-negative tumors.”
In this open-label, multicenter study, 188 patients with locally advanced, unresectable, or metastatic urothelial carcinoma were enrolled to receive bempegaldesleukin plus nivolumab every 3 weeks for ≤2 years or until disease progression or unacceptable toxicity. The primary end point was ORR by blinded independent central review among patients with low PD-L1 expression (n = 123). A key secondary end point was ORR and exploratory end points included PFS, OS, and safety in the overall population.
At analysis, the ORR was 17.9% among patients with PD-L1–low tumors. The ORR was 19.7% in the overall population. The median PFS was 3 months, and the median OS was 12.6 months. This combination was well tolerated, and no new or unexpected safety signals were observed.
As Dr Siefker-Radtke et al concluded, “The addition of bempegaldesleukin to the PD-1 checkpoint inhibitor nivolumab did not improve clinical benefit.”
Source:
Siefker-Radtke AO, Huddart RA, Bilen MA, et al. Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10). Urol Oncol: Semin Orig Invest. Published online: October 29, 2024. doi:10.1016/j.urolonc.2024.09.030
