医学
彭布罗利珠单抗
内科学
临床终点
肿瘤科
胃肠病学
癌症
临床试验
免疫疗法
作者
Enriqueta Felip,Matthew D. Hellmann,Rina Hui,Enric Carcereny,Natasha B. Leighl,Myung‐Ju Ahn,Joseph P. Eder,Ani Sarkis Balmanoukian,Charu Aggarwal,Leora Horn,Amita Patnaik,Matthew A. Gubens,Suresh S. Ramalingam,Erin Jensen,Debra Kush,Edward B. Garon
标识
DOI:10.1200/jco.2018.36.15_suppl.9030
摘要
9030 Background: Pembrolizumab (pembro) has shown antitumor activity in patients (pts) with advanced NSCLC and is standard-of-care therapy for pts with PD-L1‒expressing tumors (first-line, TPS ≥50%; previously treated, TPS ≥1%). KEYNOTE-001, an open-label phase 1b study, evaluated pembro monotherapy in treatment-naive or previously treated pts with advanced NSCLC (NCT01295827). We report a 4-y update of KEYNOTE-001. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor tissue sample for evaluation of PD-L1 levels by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. Primary efficacy endpoint was ORR. OS was a secondary endpoint. Results: As of data cutoff (Sep 1, 2017), among 550 pts enrolled (treatment-naive, n = 101; previously treated, n = 449), median (range) follow-up was 46.5 (37.7–63.8) mo. ORR (by investigator per irRC) was 41.6 % (95% CI, 31.9–51.8) for treatment-naive pts and 22.9% (95% CI, 19.1–27.1) for previously treated pts. Median OS was 22.3 mo (95% CI, 17.1–32.3) for treatment-naive pts and 10.5 mo (95% CI, 8.6–13.2) for previously treated pts; estimated 4-y OS rates were 27.2% and 16.4 %, respectively. Kaplan-Meier curves for OS appeared to plateau after 42 mo for treatment-naive pts and 36 mo for previously treated pts. Increased PD-L1 expression was associated with improved OS (Table). Immune-mediated AEs occurred in 24.8% of treatment-naive and 17.4% of previously treated pts. No additional grade 5 treatment-related AEs occurred (compared with 3-y follow-up; data cutoff Sep 1, 2016). Conclusions: Pembro provides long-term OS benefit for both treatment-naive and previously treated advanced NSCLC that expresses PD-L1. These data represent the longest efficacy and safety follow-up for pts with advanced NSCLC treated with pembro. Clinical trial information: NCT01295827.OS in subgroups defined by PD-L1 TPS. Treatment-Naive (N = 101) Previously Treated (N = 449) n Median (95% CI), mo Est. 4-y rate n Median (95% CI), mo Est. 4-y rate TPS ≥50% 27 35.4 (20.3‒NE) 48.1% 138 15.4 (10.6‒18.8) 24.8% TPS 1%–49% 52 19.5 (10.7‒26.3) NE 168 8.5 (6.0‒12.6) 15.6% TPS ≤1% Not reported* 90 8.6 (5.5‒10.6) 6.5% NE = not estimable. *Due to small pt numbers (n = 12).
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