Dr. Berg the Promise of Key Updates in Urothelial Cancer

Stephanie A. Berg, DO, medical oncologist, Dana-Farber Cancer Institute, instructor in medicine at Harvard Medical School, discusses the promise of key updates in urothelial cancer, as well as highlights how these updates continue to affect treatment decisions for patients.

In November 2022, Roche announced plans to withdraw United States indication for atezolizumab (Tecentriq) for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 tumor proportion score of at least 5%, or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. After the agent received accelerated approval from the FDA in April 2017, the phase 3 IMvigor130 trial (NCT02807636), which evaluated atezolizumab alone or in combination with platinum-based chemotherapy compared with placebo plus platinum-based chemotherapy, did not meet the co-primary end points of progression-free survival and overall survival.

Full data from the study will presented at the upcoming 2023 Genitourinary Cancers Symposium. Oncologists have been interested in this study since its inception due to its evaluation of atezolizumab both as monotherapy and in combination with chemotherapy, Berg notes.

Moreover, the phase 3 KEYNOTE-361 trial (NCT02853305) evaluated pembrolizumab (Keytruda) alone and in combination with chemotherapy vs chemotherapy alone in patients with advanced or metastatic urothelial carcinoma. In August 2021, the FDA granted full approval to pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.

Although data have already been read out from this trial and the combination did not demonstrate a benefit over chemotherapy alone, single-agent pembrolizumab can have a role in the treatment of this patient population, Berg says. However, it remains unclear exactly what that role should be, and additional data could help inform guidelines for the use of pembrolizumab alone, Berg concludes.