Metastatic urothelial carcinoma harboring ERBB2/3 mutations dramatically respond to chemotherapy plus anti-PD-1 antibody: A case report

Table 1 United States Food and Drug Administration approval of immune checkpoint inhibitors in urothelial carcinoma

Anti-PD-L1 antibodies	Approvals of FDA	Clinical trials
US FDA approval of anti-PD-L1 antibodies in UC
Atezolizumab	May 18, 2016: As second-line monotherapy for patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 mo of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy	IMvigor 210
	Initial approval April 2017 and modified June 19, 2018 (restricted to PD-L1+): as first-line monotherapy for patients with locally advanced or metastatic UC who: 1) are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells covering ≥ 5% of the tumor area), as determined by an FDA-approved test, or 2) are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status	IMvigor 210, IMvigor130
Avelumab	May 9, 2017: As second-line monotherapy for patients with locally advanced or metastatic UC whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy	JAVELIN1b
	June 30, 2020: As maintenance treatment for patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy	JAVELIN Bladder 100
Durvalumab	May 1, 2017: As second-line monotherapy for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 mo of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy	NCT01693562
US FDA approval of anti-PD-1 antibodies in UC
Anti-PD-1 antibodies	Approvals of FDA	Clinical trials
Nivolumab	February 2, 2017: As second-line monotherapy for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.	Checkmate 275
Pembrolizumab	May 18, 2017: As second-line monotherapy for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or within 12 mo of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy	Keynote-045
	May 18, 2017: As first-line monotherapy for patients with locally advanced or metastatic UC who are not eligible for cisplatin-containing chemotherapy.	Keynote-052

UC: Urothelial carcinoma; FDA: Food and Drug Administration; US: United States; PD-L1: PD-ligand 1; PD-1: Programmed death-1.