84O Neoadjuvant nivolumab (N) + platinum-doublet chemotherapy (C) for resectable NSCLC: 3-y update from CheckMate 816
نویسندگان
چکیده
The phase III CheckMate 816 study demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) pathologic complete response (pCR) with neoadjuvant N + C vs patients (pts) resectable NSCLC. Here, we report 3-y efficacy, safety, exploratory biomarker analyses from 816. Adults stage IB (tumors ≥4 cm)–IIIA (per AJCC 7th ed) NSCLC, ECOG PS ≤ 1, no known EGFR/ALK alterations were randomized to 360 mg Q3W or alone for 3 cycles followed by surgery. Primary endpoints EFS pCR, both per blinded independent review. Exploratory included surgical approach extent/completeness of resection, pCR a 4-gene (CD8A, CD274, STAT-1, LAG-3) inflammatory signature score derived RNA sequencing baseline (BL) tumor samples. At median follow-up 41.4 mo (database lock, Oct 14, 2022), continued benefit was observed (HR, 0.68; 95% CI, 0.49–0.93); rates 57% 43%, respectively. improved pts who had surgery, regardless extent R0 resection (table). Recurrence occurred 28% 42% surgery the (n = 149) arms 135), In arm, BL scores numerically higher without, high low (data be presented). Grade 3–4 treatment-related surgery-related adverse events 36% 11% respectively, 38% 15% arm. Neoadjuvant continues provide long-term clinical resection. treated suggested that inflammation may associated pCR.
منابع مشابه
An open label randomized Phase III trial of nivolumab or nivolumab plus ipilimumab vs platinum doublet chemotherapy (PT-DC) in patients with chemotherapy-naïve stage IV or recurrent non-small cell lung cancer (NSCLC) (CheckMate 227)
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ژورنال
عنوان ژورنال: Journal of Thoracic Oncology
سال: 2023
ISSN: ['1556-0864', '1556-1380']
DOI: https://doi.org/10.1016/s1556-0864(23)00338-6