Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F24%3A10001332" target="_blank" >RIV/00064190:_____/24:10001332 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/24:10482528 RIV/00064203:_____/24:10482528

Výsledek na webu

<a href="https://doi.org/10.17650/1726-9776-2024-20-1-24-35" target="_blank" >https://doi.org/10.17650/1726-9776-2024-20-1-24-35</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.17650/1726-9776-2024-20-1-24-35" target="_blank" >10.17650/1726-9776-2024-20-1-24-35</a>

Jazyk výsledku

ruština

Název v původním jazyce

[Исследование III фазы CLEAR у пациентов с распространенным почечно-клеточным раком: анализ в подгруппах больных, получавших ленватиниб с пембролизумабом и сунитиниб]

Popis výsledku v původním jazyce

Introduction. The phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features. Methods. In CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival, overall survival, and objective response rate were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology. Results. In all the assessed subgroups, median progression-free survival was longer with lenvatinib plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (hazard ratio (HR) 0.33; 95 % confidence interval (CI) 0.21-0.52) and patients with sarcomatoid features (HR 0.39; 95 % CI 0.18-0.84). Median overall survival favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95 % CI 0.30-0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95 % CI 0.32-2.58); though for many groups, median overall survival was not reached. Objective response rate also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern. Conclusion. Efficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC - irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC.

Název v anglickém jazyce

Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms

Popis výsledku anglicky

Introduction. The phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features.Methods. In CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival, overall survival, and objective response rate were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology.Results. In all the assessed subgroups, median progression-free survival was longer with lenvatinib plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (hazard ratio (HR) 0.33; 95 % confidence interval (CI) 0.21-0.52) and patients with sarcomatoid features (HR 0.39; 95 % CI 0.18-0.84). Median overall survival favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95 % CI 0.30-0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95 % CI 0.32-2.58); though for many groups, median overall survival was not reached. Objective response rate also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern.Conclusion. Efficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC - irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Onkourologiya

ISSN

1726-9776

e-ISSN

—

Svazek periodika

20

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

RU - Ruská federace

Počet stran výsledku

12

Strana od-do

24-35

Kód UT WoS článku

001249178200002

EID výsledku v databázi Scopus

2-s2.0-85195789359