Urothelial Cancer

In case you missed it, here is a recap of the most popular episodes of OncLive On Air® from 2023.

Findings from the EV-302 trial presented at the 2023 ESMO Congress revealed that the combination of enfortumab vedotin and pembrolizumab may become the preferred frontline standard of care for patients with locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility.

Bupathi highlights key points that were presented at an OncLive Institutional Perspectives in Cancer, including implications of the EV-302 trial findings; data updates from the phase 1/2 ICRA trial; and future directions for urothelial cancer.

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

Lance C. Pagliaro, MD, highlights updated data from the JAVELIN Bladder 100 and EV-103 trials in metastatic urothelial carcinoma, discusses their relevance for navigating the expanding treatment armamentarium for this disease, and outlines several future avenues for research.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

Bradley A. McGregor, MD, expands on the feasibility and safety considerations addressed through the design and methodology of the DAD study; highlights dose-limiting toxicities and early responses seen with sacituzumab govitecan plus enfortumab vedotin in treatment-resistant mUC; and explains how these results support further investigation of other ADC doublets.

Thomas Powles, MD, MBBS, MRCP, discusses key background information about the EV-302 trial; the efficacy and safety findings from this trial; and the future implications of the data from several emerging trials in urothelial cancer.

Preliminary findings from the phase 3 BOND-003 trial showed that treatment with cretostimogene grenadenorepvec led to sustained and durable complete responses and a tolerable safety profile in patients with high-risk non-muscle invasive bladder cancer who are unresponsive to Bacillus Calmette-Guerin.

The FDA has granted priority review to a supplemental biologics license application for enfortumab vedotin plus pembrolizumab for the frontline treatment of patients with locally advanced or metastatic urothelial cancer.

Nadofaragene firadenovec-vncg led to encouraging rates of high-grade recurrence-free survival and overall survival in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Guru P. Sonpavde, MD, discusses the significance of data from the phase 3 CheckMate 901 trial of concurrent frontline nivolumab plus chemotherapy in metastatic or unresectable urothelial carcinoma.

Perioperative enfortumab vedotin elicited responses in cisplatin-eligible patients with muscle-invasive bladder cancer.

The combination of enfortumab vedotin-ejfv plus pembrolizumab represents a chemotherapy-free regimen that could alter the standard of care in the frontline treatment of all patients with metastatic urothelial carcinoma.

Arlene O. Siefker-Radtke, MD, discusses the efficacy of erdafitinib in patients with metastatic urothelial cancer with select FGFR alterations in the phase 3 THOR study.

Gautam Jayram, MD, discusses the current indications for immunotherapy agents in the bladder cancer treatment paradigm, as well as immune-related adverse effects to be aware of when treating patients who are receiving these therapies.

Gautam Jayram, MD, discusses current standards of care in the bladder cancer treatment arena, novel therapies under investigation in clinical trials that may expand the arsenal of available treatment strategies, and emphasizes the importance of implementing bladder cancer programs.

Building a successful bladder cancer program requires clinicians to employ a multifaceted approach that prioritizes good surgical practices, embraces immunotherapies with an understanding of the adverse effects that can accompany them, and being up to date in terms of options for patients.

Combining sacituzumab govitecan-hziy and enfortumab vedotin-ejfv was safe, feasible, and produced high and early response rates in patients with treatment-resistant metastatic urothelial cancer.

Terence Friedlander, MD, presents significant data from the EV-302/KEYNOTE-A39 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

James Catto, MB, ChB, PhD, FRCS, discusses the utility of erdafitinib in patients with high-risk non–muscle-invasive bladder cancer with select FGFR alterations who have received prior treatment with Bacillus Calmette–Guérin.

Marijo Bilusic, MD, PhD, discusses key trials in the treatment armamentarium for patients with urothelial carcinoma, as presented at the 2023 Sylvester Annual Oncology Updates Meeting.

Vivek K. Narayan, MD, MS, discusses potential avenues for treatment considerations in patients with metastatic urothelial carcinoma.

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

The intravesical chemotherapy delivery system TAR-200 provided sustained and durable responses in patients with Bacillus Calmette-Guérin–unresponsive, high-risk, non–muscle-invasive bladder cancer.

Frontline treatment with the combination of enfortumab vedotin-ejfv and pembrolizumab led to a statistically significant improvement in overall survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Concurrent frontline nivolumab and gemcitabine-cisplatin followed by nivolumab maintenance therapy elicited OS and PFS benefits vs gemcitabine-cisplatin alone in patients with previously untreated, metastatic or unresectable urothelial carcinoma.

Lance C. Pagliaro, MD, discusses the efficacy of first-line avelumab maintenance therapy, as seen in the phase 3 JAVELIN Bladder 100 trial in patients with advanced urothelial carcinoma.

Marijo Bilusic, MD, PhD, discusses updates seen in the treatment armamentarium for patients with urothelial carcinoma, as presented at the 2023 Sylvester Annual Oncology Updates Meeting.