Improved survival for patients with lung cancer treated with perioperative immunotherapy
Mené sur 797 patients atteints d'un cancer du poumon non à petites cellules de stade précoce et résécable (durée médiane de suivi : 36,6 mois), cet essai multicentrique de phase III évalue l'efficacité, du point de vue de la survie globale et de la survie sans événement, et la toxicité de l'ajout du pembrolizumab à une chimiothérapie néoadjuvante, avec ou sans pembrolizumab en traitement adjuvant
Résumé en anglais
Neoadjuvant and perioperative immune checkpoint inhibitor (ICI) therapy combined with chemotherapy has led to improvement in pathological response rates and event-free survival for patients with resectable non-small cell lung cancer (NSCLC).1–3 In October, 2023, perioperative pembrolizumab in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by adjuvant pembrolizumab was approved by the US Food and Drug Administration (FDA) for patients with resectable stage II–III NSCLC based on the KEYNOTE-671 trial.3 Until now, the impact of surrogate endpoints on overall survival was uncertain. In The Lancet, Jonathan D Spicer and colleagues4 report the results of a pre-planned second interim analysis from KEYNOTE-671, which was a global, phase 3 randomised trial of patients with stage II, IIIA, or IIIB (N2) NSCLC of neoadjuvant chemotherapy plus pembrolizumab followed by surgery and adjuvant pembrolizumab compared with placebo-controlled neoadjuvant chemotherapy. As previously reported,3 the majority of participants were younger than 65 years (435 [55%] of 797), male (563 [71%]), current or former smokers (696 [87%]), and had stage III disease (558 [70%]). In this second interim analysis, Spicer and colleagues found that perioperative pembrolizumab led to improved overall survival in addition to event-free survival without a significant change in patient-reported health-related quality of life (HRQoL). The median estimated 3-year overall survival was 71% (95% CI 66–76) in the perioperative pembrolizumab group compared with 64% (58–69) in the placebo-controlled neoadjuvant chemotherapy-only group (hazard ratio [HR] 0·72 [95% CI 0·56–0·93]; p=0·0052). The median overall survival was not reached in the pembrolizumab-treated patients compared with 52·4 months in the placebo group (95% CI 45·7 to not reached). This study builds on previous practice-changing phase 3 trials demonstrating the benefit of adjuvant, neoadjuvant, and perioperative ICI therapy compared with chemotherapy-only approaches, and the improvement in overall survival reported here is a landmark in the long journey of curing more patients with NSCLC.
