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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

The result's identifiers

  • Result code in 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>

  • Result on the web

    <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>

Alternative languages

  • Result language

    angličtina

  • Original language name

    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

  • Original language description

    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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30204 - Oncology

Result continuities

  • Project

  • Continuities

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Others

  • Publication year

    2022

  • Confidentiality

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

Data specific for result type

  • Name of the periodical

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

  • ISSN

    0923-7534

  • e-ISSN

    1569-8041

  • Volume of the periodical

    33

  • Issue of the periodical within the volume

    4

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    3

  • Pages from-to

    451-453

  • UT code for WoS article

    000797530500002

  • EID of the result in the Scopus database