Emily Menendez

GU Oncology Now

The phase 3 EV-301 trial compared the efficacy of enfortumab vedotin (EV) against chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. An exploratory analysis <a href="https://www.annalsofoncology.org/article/S0923-7534(23)00832-3/fulltext#%20" target="_blank" rel="noopener">recently evaluated the long-term findings of the study, with a median follow-up of approximately 2 years.</a>The study included 608 patients who previously experienced disease progression during or after PD-1/L1 inhibitor treatment. Patients were randomized to receive either EV or a chemotherapy treatment of docetaxel, paclitaxel, or vinflunine. A total of 301 patients received EV, while 307 underwent chemotherapy.The primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), objective response, and safety. With a median follow-up of 23.75 months, 444 deaths occurred (EV n=207; chemotherapy n=237). The risk of death was reduced by 30% with EV versus chemotherapy (hazard ratio [HR], 0.70; 95% CI, 0.58-0.85; 1-sided, log-rank P=.00015), while PFS was also improved with EV (HR, 0.63; 95% CI, 0.53-0.76; 1-sided, log-rank P&lt;.00001).Adverse events (AEs) grade &ge;3 occurred in 52.4% of patients treated with EV and 50.5% of patients treated with chemotherapy. Grade &ge;3 treatment-related decreased neutrophil count (14.1% vs 6.1%), decreased white blood cell count (7.2% vs 1.4%), and anemia (7.9% vs 2.7%) were more common in patients treated with chemotherapy versus EV, while maculopapular rash (7.4% vs 0%), fatigue (6.8% vs 4.5%), and peripheral sensory neuropathy (5.1% vs 2.1%) were more common in patients treated with EV.Other special interest AEs, such as treatment-related skin reactions, occurred in 47.3% of patients receiving EV and 15.8% of patients receiving chemotherapy; peripheral neuropathy occurred in 48.0% versus 31.6%, respectively, and hyperglycemia occurred in 6.8% versus 0.3%, respectively.After a median follow-up of approximately 2 years, EV showed clinically meaningful OS benefit over chemotherapy, a result that was consistent with findings from the EV-301 primary analysis. PFS and overall response benefit remained consistent. AEs were manageable, and no new safety signals were observed.

EV-301 2-Year Follow-up Shows Consistent Benefit of EV Over Chemotherapy for Urothelial Carcinoma

Advanced Urothelial Carcinoma

The positive results of the EV-301 2-year follow-up were consistent with findings from the primary analysis, such as PFS and overall response benefit.

EV-301 Year Follow-up Shows Benefit of EV Over Chemotherapy

About Us

Contributors and Partners

Editorial Policy

Advertising

eNewsletters

Calendar

Contact Us

Contribute

MashupMD

Cancer Nursing Today

Urban Health Today

Blood Cancers Today

DocWire News

Knowledge Hubs

Conference Coverage

Roundtables

The Uromigos

Uromigos Live 2024

AUC3

Localized

mHSPC/mCSPC

CRPC

Diagnostics

Prostate Cancer

Localized Renal Cell Carcinoma

Advanced Renal Cell Carcinoma

nccRCC

Renal Cell Carcinoma

Non-Muscle Invasive Urothelial Carcinoma

Muscle Invasive Urothelial Carcinoma

Upper Tract Urothelial Carcinoma

Urothelial Carcinoma

Testicular, Penile, and Rare Cancers

Video Insights

Advancements in Oncology

The Oncology Brothers

Expert Interviews

Journal

Subscribe