Bladder Cancer

Nivolumab monotherapy administered after surgery demonstrated a significant improvement in disease-free survival compared with placebo in patients with high-risk, muscle-invasive urothelial carcinoma, for all patients randomized in the phase 3 CheckMate-274 trial and those with PD-L1 ≥1% in their tumors, meeting the primary end point of the study.

Enfortumab vedotin monotherapy demonstrated significant long-term results in updated findings from the EV-201 trial presented at the 2020 ESMO Virtual Congress.

Petros Grivas, MD, PhD, discusses the challenge with biomarker discovery currently in the treatment landscape of urothelial carcinoma.

Final results from cohort 1 of the phase 3 TROPHY-U-01 trial reported continued significant activity with sacituzumab govitecan-hziy as treatment of patients with metastatic urothelial carcinoma who progressed on both platinum-based chemotherapy and checkpoint inhibition.

The co-primary end points of overall survival in patients with metastatic urothelial cancer were not met in the phase 3 DANUBE trial of durvalumab in combination with tremelimumab and durvalumab monotherapy, according to results presented at the 2020 ESMO Virtual Congress.

Although responses were observed with induction avelumab prior to standard of care gemcitabine/carboplatin, clinically meaningful efficacy was not sustained for patients with metastatic urothelial carcinoma.

Avelumab in combination with best supportive care as frontline maintenance in patients with advanced or metastatic urothelial carcinoma who had not progressed on first-line platinum-based chemotherapy led to improvements in both progression-free and overall survival.

The addition of BGB-A333 to tislelizumab led to marked antitumor activity and durable responses with a tolerable safety profile as treatment of patients with urothelial carcinoma in the phase 1/2 BGB-900-101 study.

The global phase 3 EV-301 study of enfortumab vedotin-ejfv in adult patients with locally advanced or metastatic urothelial carcinoma who received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor met its primary end point of overall survival compared with chemotherapy.

Neeraj Agarwal, MD, reviews the case of a 73-year-old man with unresectable, locally advanced urothelial carcinoma and discusses latest data and treatment approaches.

Arjun V. Balar, MD, reviewed the data from the KEYNOTE-057 and how they impact the treatment of urothelial cancer in an editorial note.

Dr Robert Dreicer reviews a case of advanced urothelial cancer and explains the patient’s eligibility for platinum-based chemotherapy followed by maintenance therapy with a checkpoint inhibitor.

The FDA has accepted a Biologics License Application for a new 4-week fixed-dose regimen containing durvalumab and granted it Priority Review for the approved indications of non–small cell lung cancer, as well as bladder cancer.