Amivantamab plus chemotherapy vs chemotherapy as first-line treatment among patients with EGFR exon 20 insertion–mutated advanced non-small cell lung cancer (NSCLC): PAPILLON Chinese subgroup analysis.

• DOI: 10.1200/jco.2024.42.16_suppl.8606
• Publication Date: 2024-06-26T17:00:34Z
• Authors: Ke-Jing Tang; Baogang Liu; Yu Yao; Yanqiu Zhao; Jianying Zhou; Ping Sun; Donglin Wang; Dongqing Lv; Huijie Wang; Yi Hu; Qiang Li; Yujiao Song; Grace Gao; Liyun Wang; Trishala Agrawal; Archan Bhattacharya; Mahadi Baig; Patricia A Lorenzini; Honeylet Wortman-...; Caicun Zhou
• Keywords: 03 medical and health sciences; 0302 clinical medicine

8606 Background: Amivantamab (Ami) is a bispecific antibody targeting EGFR and MET tyrosine kinase receptors with immune cell-directing activity. The phase 3 PAPILLON study (NCT04538664) investigated the combination of Ami carboplatin/pemetrexed (ACP) vs. (CP) as first-line treatment in patients (pts) advanced Exon20ins-mutated NSCLC. ACP improved progression free survival (PFS) both overall population Asian subgroup. Methods: Pts were randomized 1:1 to or CP. primary endpoint was PFS by blinded independent central review (BICR) key secondary endpoints included objective response rate (ORR), after first subsequent therapy (PFS2), (OS), safety. Crossover monotherapy allowed for pts CP arm following disease progression. Results: Among 308 enrolled, 87 Chinese, 39 receiving 48 Median age 57/57 years, 46%/63% female, 15%/25% history brain metastases ACP/CP arms. Baseline characteristics generally balanced between After median follow-up 16.4 months (mo), 12.3 mo (95% CI: 7.00, NE) compared 6.7 4.21, 8.57) (hazard ratio [HR], 0.47; 95% CI, 0.26-0.85; P = 0.011) (Table). ORR 71.8% 55.1%-85.0%) ACP, 48.9% 34.1%–63.9%) (odds ratio, 2.46; 1.01-5.98; 0.048). PFS2 not estimable (NE) vs 18.8 (HR, 0.32; 0.11-0.88; 0.021). Interim OS showed favorable trend 0.58; 0.17-2.02; 0.387) despite crossover among CP-randomized (n 24, 50%) who had progressed. Most common AEs (all grades) ( > rash, paronychia, hypoalbuminemia, neutropenia, anemia, leukopenia thrombocytopenia which consistent known safety profile individual agents. Notably, no discontinuation due an AE. Conclusions: demonstrated superior Chinese pts. manageable tolerable. These findings subgroup those Clinical trial information: NCT04538664 . [Table: see text]