Dr. Singh on Novel Therapies in Advanced Urothelial Cancer

Parminder Singh, MD
Published: Tuesday, Oct 29, 2019



Parminder Singh, MD, hematologist/oncologist, Mayo Clinic, discusses the improvement in overall response rates (ORR) with immunotherapy, targeted therapy, and antibody-drug conjugates (ADCs) in advanced urothelial cancer. 
 
Traditionally, patients who progress on chemotherapy have a median survival of 6 to 8 months, says Singh. The approval of 5 checkpoint inhibitors: atezolizumab (Tecentriq), pembrolizumab (Keytruda), nivolumab (Opdivo), avelumab (Bavencio), and durvalumab (Imfinzi), as well as the FGFR inhibitor erdafitinib (Balversa), have changed the paradigm. 
 
Checkpoint inhibitors have shown an objective response rate (ORR) of 15% to 20%, says Singh. Notably, 70% to 80% of patients who respond have durable responses. Furthermore, patients expressing PD-L1 have higher response rates. 
 
Regarding erdafitinib, investigators reported an ORR of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic bladder cancer in the phase II BLC2001 trial. The data from the trial served as the basis for the agent’s accelerated approval in patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. 
 
Finally, the ADC enfortumab vedotin demonstrated an ORR of 44% in previously treated patients with locally advanced or metastatic disease in the phase II EV-201 trial. In September 2019, the FDA granted a priority review designation to a biologics license application for the agent in this indication. 
 
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Parminder Singh, MD, hematologist/oncologist, Mayo Clinic, discusses the improvement in overall response rates (ORR) with immunotherapy, targeted therapy, and antibody-drug conjugates (ADCs) in advanced urothelial cancer. 
 
Traditionally, patients who progress on chemotherapy have a median survival of 6 to 8 months, says Singh. The approval of 5 checkpoint inhibitors: atezolizumab (Tecentriq), pembrolizumab (Keytruda), nivolumab (Opdivo), avelumab (Bavencio), and durvalumab (Imfinzi), as well as the FGFR inhibitor erdafitinib (Balversa), have changed the paradigm. 
 
Checkpoint inhibitors have shown an objective response rate (ORR) of 15% to 20%, says Singh. Notably, 70% to 80% of patients who respond have durable responses. Furthermore, patients expressing PD-L1 have higher response rates. 
 
Regarding erdafitinib, investigators reported an ORR of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic bladder cancer in the phase II BLC2001 trial. The data from the trial served as the basis for the agent’s accelerated approval in patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. 
 
Finally, the ADC enfortumab vedotin demonstrated an ORR of 44% in previously treated patients with locally advanced or metastatic disease in the phase II EV-201 trial. In September 2019, the FDA granted a priority review designation to a biologics license application for the agent in this indication. 
 



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