GU Oncology Now Editors

GU Oncology Now

Findings from the LEAP-011 study were presented during the general session, Novel Therapies and Their Toxicities in Bladder Cancer, at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. Researchers, led by Yohann Loriot, Phd, MD, compared pembrolizumab and lenvatinib against pembrolizumab and placebo for locally advanced or metastatic urothelial carcinoma (UC), and observed that &ldquo;the benefit/risk ratio for pembro + lenva was not considered positive vs pembro + placebo in platinum-ineligible pts with advanced UC.&rdquo;The study randomized 441 patients with locally advanced or metastatic UC who were cisplatin-ineligible with PD-L1 expression, or were ineligible for platinum-based chemotherapy, to receive pembrolizumab 200mg intravenous (IV) Q3W for 35 cycles max (approx. 2 years) and either daily oral lenvatinib 20mg (n = 218) or a placebo (n = 223). The study&rsquo;s primary endpoints were progression-free survival (PFS), and overall survival (OS), with objective response rate (ORR) as the secondary endpoint&mdash;all based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.According to the report, the median treatment duration was 3.8 months for the intervention group (range: 0.0-20.7) and 3.4 months for the placebo group (range: 0.0 22.0). In the intervention group, the median PFS was 4.2 months (95% confidence interval [CI], 3.8 5.9), while the placebo group&rsquo;s PFS was 4.0 months (hazard ratio [HR] = 0.91; 95% CI, 0.71-1.16). The median OS for pembrolizumab with lenvatinib and pembrolizumab with placebo was 11.2 months (95% CI, 3.8-5.9) and 13.8 months (95% CI, 9.8-18.8), respectively (HR = 1.25; 95% CI, 0.94-1.67), with the placebo group having a higher OS rate at six months (70.7% vs. 63.6%). ORR did favor the intervention regimen over the placebo (31.2% vs. 26.5%), however, the rate of treatment-related adverse events (TRAEs) was higher in the intervention versus placebo group (86.9% vs. 67.1%).While the safety profile of pembrolizumab with lenvatinib was consistent with previous studies, the head-to-head comparison did not find an effective improvement in clinical outcomes, according to Dr. Loriot and collaborators. They concluded that pembrolizumab monotherapy should remain the &ldquo;standard of care as first-line therapy in platinum-ineligible pts with advanced UC.&rdquo;Conference Link: <a href="https://meetings.asco.org/2022-asco-genitourinary-cancers-symposium/14110?presentation=205975#205975">https://meetings.asco.org/2022-asco-genitourinary-cancers-symposium/14110?presentation=205975#205975</a>

Pembrolizumab With Lenvatinib or Placebo for Patients with Advanced Urothelial Carcinoma

American Society of Clinical Oncology Genitourinary Cancers Symposium 2022

ASCO GU Symposium 2022

Pembrolizumab and lenvatinib didn’t effectively improve clinical outcomes for patients with locally advanced or metastatic UC.

Pembrolizumab With Lenvatinib, Placebo for Patients With UC

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

Advanced 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