GENITOURINARY CANCERS

The FDA has accepted a Biologic License Application for Vicineum as a treatment option for patients with high-risk, Bacillus Calmette-Guerin-unresponsive non–muscle invasive bladder cancer, and granted it Priority Review,.

Findings from the phase 3 CLEAR trial showed that the addition of lenvatinib to either pembrolizumab or everolimus led to an improvement in survival and response rates in comparison with sunitinib monotherapy in the first-line setting for patients with advanced renal cell carcinoma.

The addition of the oral hypoxia-inducible factor 2α inhibitor belzutifan to cabozantinib led to disease control in a majority of patients with previously treated advanced clear cell renal cell carcinoma, according to preliminary results from a phase 2 trial presented at the 2021 Genitourinary Cancers Symposium.

Cabozantinib reduced the risk of disease progression or death by 40% in comparison with sunitinib in patients with metastatic papillary renal cell carcinoma, according to findings from the randomized phase 2 SWOG 1500 study.

A molecular signature has been identified that can characterize long-term responders from treatment with apalutamide and androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer, according to findings, presented at the 2021 Genitourinary Cancers Symposium.

In patients with non-muscle invasive bladder cancer carcinoma in-situ who were unresponsive to Bacillus Calmette-Guerin, the addition of N-803 induced a high rate of complete responses, findings from a cohort of the phase 2/3 QUILT-3.032 study showed.

Localized metastatic lesions were detected with a high correct localization rate (CLR) and positive predictive value (PPV) with the investigational prostate-specific membrane antigen (PSMA)–targeted PET imaging agent 18F-DCFPyL.

Patrick G. Pilié, MD, explains how the safety profile of darolutamide, as seen in the ARAMIS clinical trial, differs from those of enzalutamide and apalutamide.

Apalutamide in combination with androgen deprivation therapy led to a reduction in the risk of death of 35% in comparison with ADT alone for patients with metastatic castration-sensitive prostate cancer in a final analysis of the phase 3 TITAN trial.

Enfortumab vedotin demonstrated superior efficacy compared with chemotherapy in patients with advanced urothelial carcinoma who had previously received platinum-based chemotherapy and PD-1/L1 inhibition, according to results from a primary analysis of the phase 3 EV-301 clinical trial.

Nivolumab in combination with cabozantinib continues to demonstrate superior efficacy over sunitinib monotherapy in the frontline treatment of patients with advanced renal cell carcinoma, according to extended follow-up data from the phase 3 CheckMate 9ER trial.

A novel prostate-specific membrane antigen–targeted radiopharmaceutical for positron emission tomography known as 18F-DCFPyL, may help to identify occult prostate cancer and more accurately characterize disease burden, according to a subanalysis of the OSPREY trial presented during the 2021 Genitourinary Cancers Symposium.

In patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), crossover from placebo to darolutamide (Nubeqa) appeared have minimal impact on the overall survival (OS) benefit observed with the androgen receptor inhibitor in the pivotal phase 3 ARAMIS trial.

During a Targeted Oncology Case-Based Peer Perspectives Roundtable, Tanya Dorff, MD, reviews the available treatment options for nonmetastatic castration-resistant prostate cancer to select a treatment for 57-year-old patient.

An exploratory analysis of the phase 3 IMvigor130 trial demonstrated that the benefit of frontline atezolizumab added to gemcitabine and platinum chemotherapy was maintained in patients with urothelial cancer, regardless of the site of the primary tumor.

During a Targeted Oncology Case-Based Peer Perspectives Roundtable, two Mayo Clinic experts, Alan H. Bryce, MD, and Roxana S. Dronca, MD, discuss treatment options for a 66-year-old woman with urothelial carcinoma.

After decades of dormancy, the therapeutic landscape of locally advanced/metastatic urothelial cancer underwent a paradigm shift—with multiple regulatory approvals of immune checkpoint inhibitors as second-line treatment—leading to changes in guideline-recommended management of patients in this setting.

Anthony A. Meluch, MD, medical oncologist, Tennessee Oncology, discussed treatment options for high-risk adenocarcinoma of the prostate based on the case of a 75-year-old patient during a Targeted Oncology Case-Based Peer Perspectives event.

Experts in oncology and hematology review some of the most impactful FDA approvals from 2020 in lung, breast, blood, gastrointestinal, and genitourinary cancers.

Michael A. Carducci, MD, provided recommendations for treatment of a 75-year-old man with castrastion-resistant prostate cancer.

Durable responses were shown with the investigational agent UGN-102 as treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer, according to final results of the phase 2b OPTIMA II study .

In genitourinary cancers, presentation of subgroup analysis data from large randomized clinical trials demonstrated findings that will change practice for oncologists who treat patients with prostate cancer, bladder cancer, and renal cell carcinoma.

Bradley McGregor, MD, discusses the CheckMate-9ER trial of nivolumab plus cabozantinib versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma.

Biomarkers of immune activity were linked with overall survival benefit to frontline maintenance avelumab in patients with advanced urothelial cancer, according to data presented at the ESMO Virtual Congress 2020 from an exploratory analysis of the phase 3 JAVELIN Bladder 100 trial.

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.

Stratified multivariate analysis as well as efficacy from multiple treatment time points confirmed the benefit of cabazitaxel over abiraterone acetate or enzalutamide as a standard treatment in men with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and either of those 2 androgen receptor-targeted agents, according to results presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program.

"Irrespective of the PD-L1 status, there were no trends in favor of atezolizumab in both arms."

Patients with urothelial carcinoma who progress after platinum-containing chemotherapy may receive benefit with the combination regimen of cabozantinib and atezolizumab, according to new data from the COSMIC-021 study.

"These interim data demonstrate that primary chemoablation of low-grade intermediate-risk non–muscle invasive bladder cancer using UGN-102 results in a significant treatment response and encouraging durability."

"Intravesical nadofaragene firadenovec [recombinant adenovirus interferon alpha achieved a 53.4% CR rate in patients with BCG-unresponsive carcinoma in situ of the bladder."