Vše

Co hledáte?

Vše
Projekty
Výsledky výzkumu
Subjekty

Rychlé hledání

  • Projekty podpořené TA ČR
  • Významné projekty
  • Projekty s nejvyšší státní podporou
  • Aktuálně běžící projekty

Chytré vyhledávání

  • Takto najdu konkrétní +slovo
  • Takto z výsledků -slovo zcela vynechám
  • “Takto můžu najít celou frázi”

VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 e PEARLS/KEYNOTE-091 study

Identifikátory výsledku

  • Kód výsledku v IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F22%3AN0000084" target="_blank" >RIV/00064190:_____/22:N0000084 - isvavai.cz</a>

  • Výsledek na webu

    <a href="https://doi.org/10.1016/j.annonc.2022.02.224" target="_blank" >https://doi.org/10.1016/j.annonc.2022.02.224</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.annonc.2022.02.224" target="_blank" >10.1016/j.annonc.2022.02.224</a>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 e PEARLS/KEYNOTE-091 study

  • Popis výsledku v původním jazyce

    BACKGROUND Pembro is a standard of care for advanced NSCLC. PEARLS/ KEYNOTE-091 (NCT02504372) evaluated adjuvant pembro vs placebo for patients (pts) with completely resected early-stage NSCLC. METHODS Eligible pts with completely resected stage IB (T > 4 cm), II, or IIIA NSCLC per AJCC v7 followed by adjuvant chemo as indicated per guidelines, ECOG PS 0-1, and any PD-L1 expression were randomized 1:1 to pembro 200 mg or placebo Q3W for 18 doses (w1 year). Dual primary end points are DFS in the all-comers and PD-L1 TPS > 50% populations. Secondary end points are DFS in the TPS > 1% population, OS in the all-comers, TPS > 50% and > 1% populations, and safety. Data are from the protocol-specified second interim analysis (IA2; 20 September 2021, data cutoff). RESULTS 1177 pts were randomized to pembro (N = 590) or placebo (N = 587), including 168 and 165, respectively, who had TPS >= 50%. Baseline characteristics were generally balanced between arms. Median time from randomization to data cutoff for IA2 was 35.6 mo (range 16.5-68.0). DFS was significantly improved with pembro in the all-comers population (median 53.6 vs 42.0 mo; HR 0.76; 95% CI 0.63-0.91; P = 0.0014); the significance boundary was not crossed for the TPS >= 50% population (median not reached in either arm; HR 0.82; 95% CI 0.57-1.18; P = 0.14). With only 209 events, the significance boundary for OS in the all-comers population was not crossed (18-mo rate 91.7% vs 91.3%; HR 0.87; 95% CI 0.67-1.15; P = 0.17). Median number of doses was 17 for pembro vs 18 for placebo. AEs were grade >= 3 in 34.1% of pts in the pembro arm vs 25.8% in the placebo arm and led to discontinuation in 19.8% vs 5.9%; treatment-related AEs led to death in 0.7% vs 0%. CONCLUSIONS Adjuvant pembro provided a statistically significant, clini-cally meaningful DFS improvement following complete resection and, when indicated, adjuvant chemo in pts with stage IB (T >= 4 cm)-IIIA NSCLC, regardless of PD-L1 expression. The pembro safety profile was as expected. DFS in the PD-L1-defined populations and OS will be tested at future analyses according to the analysis plan.

  • Název v anglickém jazyce

    VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 e PEARLS/KEYNOTE-091 study

  • Popis výsledku anglicky

    BACKGROUND Pembro is a standard of care for advanced NSCLC. PEARLS/ KEYNOTE-091 (NCT02504372) evaluated adjuvant pembro vs placebo for patients (pts) with completely resected early-stage NSCLC. METHODS Eligible pts with completely resected stage IB (T > 4 cm), II, or IIIA NSCLC per AJCC v7 followed by adjuvant chemo as indicated per guidelines, ECOG PS 0-1, and any PD-L1 expression were randomized 1:1 to pembro 200 mg or placebo Q3W for 18 doses (w1 year). Dual primary end points are DFS in the all-comers and PD-L1 TPS > 50% populations. Secondary end points are DFS in the TPS > 1% population, OS in the all-comers, TPS > 50% and > 1% populations, and safety. Data are from the protocol-specified second interim analysis (IA2; 20 September 2021, data cutoff). RESULTS 1177 pts were randomized to pembro (N = 590) or placebo (N = 587), including 168 and 165, respectively, who had TPS >= 50%. Baseline characteristics were generally balanced between arms. Median time from randomization to data cutoff for IA2 was 35.6 mo (range 16.5-68.0). DFS was significantly improved with pembro in the all-comers population (median 53.6 vs 42.0 mo; HR 0.76; 95% CI 0.63-0.91; P = 0.0014); the significance boundary was not crossed for the TPS >= 50% population (median not reached in either arm; HR 0.82; 95% CI 0.57-1.18; P = 0.14). With only 209 events, the significance boundary for OS in the all-comers population was not crossed (18-mo rate 91.7% vs 91.3%; HR 0.87; 95% CI 0.67-1.15; P = 0.17). Median number of doses was 17 for pembro vs 18 for placebo. AEs were grade >= 3 in 34.1% of pts in the pembro arm vs 25.8% in the placebo arm and led to discontinuation in 19.8% vs 5.9%; treatment-related AEs led to death in 0.7% vs 0%. CONCLUSIONS Adjuvant pembro provided a statistically significant, clini-cally meaningful DFS improvement following complete resection and, when indicated, adjuvant chemo in pts with stage IB (T >= 4 cm)-IIIA NSCLC, regardless of PD-L1 expression. The pembro safety profile was as expected. DFS in the PD-L1-defined populations and OS will be tested at future analyses according to the analysis plan.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30204 - Oncology

Návaznosti výsledku

  • Projekt

  • Návaznosti

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Ostatní

  • Rok uplatnění

    2022

  • Kód důvěrnosti údajů

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

Údaje specifické pro druh výsledku

  • Název periodika

    Annals of oncology : official journal of the European Society for Medical Oncology

  • ISSN

    0923-7534

  • e-ISSN

    1569-8041

  • Svazek periodika

    33

  • Číslo periodika v rámci svazku

    4

  • Stát vydavatele periodika

    GB - Spojené království Velké Británie a Severního Irska

  • Počet stran výsledku

    3

  • Strana od-do

    451-453

  • Kód UT WoS článku

    000797530500002

  • EID výsledku v databázi Scopus