Amivantamab plus chemotherapy versus chemotherapy for first-line treatment of participants with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer: PAPILLON Asia subgroup analysis

IF 5.3 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2026-03-01 Epub Date: 2026-02-02 DOI:10.1016/j.lungcan.2026.109302

Caicun Zhou , Ke-Jing Tang , Baogang Liu , Sang-We Kim , Satoru Kitazono , Akira Ono , Muthukkumaran Thiagarajan , Jen-Yu Hung , Michael Boyer , Timuçin Çİl , Yu Yao , Rajnish Nagarkar , John Xie , Archan Bhattacharya , Honeylet Wortman-Vayn , Mahadi Baig , Trishala Agrawal , Patricia Lorenzini , Se-Hoon Lee , Byoung Chul Cho

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引用次数: 0

Abstract

Background

Amivantamab is a bispecific, epidermal growth factor receptor (EGFR) and MET-proto-oncogene (MET)-targeting antibody with immune cell-directing activity. In the global Phase 3 PAPILLON trial, amivantamab plus carboplatin-pemetrexed (amivantamab-chemotherapy) significantly improved progression-free survival (PFS) vs chemotherapy alone in previously untreated participants with locally advanced/metastatic NSCLC with EGFR exon 20 insertions (Ex20ins). We evaluated clinical outcomes in Asian participants in PAPILLON (NCT04538664).

Methods

Participants were randomized 1:1 to amivantamab-chemotherapy or chemotherapy alone. Study endpoints for this analysis were PFS by blinded independent central review (primary), objective response rate (ORR), duration of response (DoR), PFS after first subsequent therapy (PFS2), overall survival (OS), and safety (secondary). Crossover to amivantamab monotherapy was allowed when disease progressed on chemotherapy alone.

Results

Among 186 participants in the Asian sub-cohort, 97 received amivantamab-chemotherapy and 89 received chemotherapy. At median follow-up of 16.6 months, median PFS (95% confidence interval [CI]) in the amivantamab-chemotherapy/chemotherapy groups was 11.5/5.6 months (hazard ratio [HR] 0.34; 95%CI, 0.23–0.49; nominal p < 0.0001) arms. The ORR was 70% vs 51% (odds ratio 2.2, 95%CI, 1.2–3.9; nominal p = 0.012), DoR 10.1 vs 5.5 months. Median PFS2 was not estimable vs 18.8 months (HR 0.46, 95%CI 0.26–0.83; nominal p = 0.008), and median interim OS not estimable vs 24.4 months HR 0.65, 95%CI 0.34–1.24; nominal p = 0.189), respectively, despite substantial (73%) crossover. Safety profiles for both arms were similar to the overall PAPILLON population.

Conclusions

Amivantamab-chemotherapy demonstrated superior PFS vs chemotherapy and represents a new standard of care for first-line treatment of Asian participants with Ex20ins-mutated NSCLC.

查看原文本刊更多论文

阿米万他单抗加化疗与化疗对EGFR外显子20插入突变晚期非小细胞肺癌患者的一线治疗：PAPILLON亚洲亚组分析

背景：阿米万他抗是一种双特异性的表皮生长因子受体（EGFR）和MET原癌基因（MET）靶向抗体，具有免疫细胞定向活性。在全球3期PAPILLON试验中，amivantamab联合卡铂-培美曲塞（amivantamab-chemotherapy）显著改善了EGFR外显子20插入（Ex20ins）的局部晚期/转移性NSCLC患者的无进展生存期（PFS）。我们评估了PAPILLON （NCT04538664）在亚洲参与者中的临床结果。方法：参试者按1:1的比例随机分为阿米万他单化疗组和单独化疗组。该分析的研究终点为盲法独立中心评价的PFS（主要）、客观缓解率（ORR）、缓解持续时间（DoR）、首次后续治疗后的PFS （PFS2）、总生存期（OS）和安全性（次要）。当单独化疗的疾病进展时，允许交叉到阿米万他单药治疗。结果：在亚洲亚队列的186名参与者中，97名接受了阿米万他单化疗，89名接受了化疗。在中位随访16.6个月时，阿米万他抗化疗/化疗组的中位PFS（95%可信区间[CI]）为11.5/5.6个月（风险比[HR] 0.34; 95%CI, 0.23-0.49; nominal p）结论：阿米万他抗化疗比化疗显示出更优的PFS，代表了ex20in突变的亚洲非小细胞肺癌患者一线治疗的新标准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.