Abstract CT218: Flat-dose nivolumab (NIVO) as second-line (2L) treatment (tx) for Asian patients (pts) with advanced non-small cell lung cancer (NSCLC): CheckMate 870

Abstract

Abstract Introduction: Weight-based dosing of NIVO over 60 minutes is approved in China for 2L NSCLC tx; however, more convenient flat dosing over a shorter infusion time has yet to be fully assessed in Asian pts. In addition, the benefit of NIVO in Asian pts with NSCLC and EGFR or ALK mutations, or hepatitis B virus (HBV) infection, has yet to be evaluated. CheckMate 870 (NCT03195491) is a phase 3b trial assessing a flat dose of NIVO infused over 30 minutes for previously treated NSCLC in Asian pts. Methods: Eligible pts had stage IIIB/IV NSCLC with 1-2 prior systemic tx and ECOG PS 0-1. Pts with HBV had to have a viral titer < 500 IU/mL. Pts received NIVO 240 mg over a 30-minute infusion, Q2W, until progression, unacceptable toxicity, or for ≤ 2 years. The primary endpoint was high-grade (G; G3-5) tx-related select adverse events (AEs) in non-HBV infected pts. Results: Of 400 treated pts, 394 were from China; 34 pts had EGFR mutations, and 383 were non-HBV infected. Median (range) age was 61 (27-80) y and 78% were male. Clinical data cutoff was May 30, 2019, median duration of tx was 3 mo. The most common categories for G3-4 tx-related select AEs in non-HBV infected pts were hepatic (2%), skin (2%), pulmonary and endocrine (1% each). There were no G5 tx-related select AEs reported in non-HBV infected pts. No G3-5 tx-related select AEs were reported in HBV-infected pts (n = 17). There were 2 tx-related deaths, due to myocarditis (non-HBV infected pt) and lung infection (HBV-infected pt). G3-4 treatment-related AEs (TRAEs) were reported in 13% of all treated pts, and 2% had G3-4 TRAEs leading to discontinuation. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) are shown in the Table. Conclusions: Flat-dosing of NIVO 240 mg over 30 minutes was well tolerated and active in a predominantly Chinese pt population with previously treated NSCLC, including pts with EGFR mutations or HBV infection. These results are similar to pivotal trials of NIVO for previously treated NSCLC. No new safety signals were reported. Table.OS, PFS, and ORR among subgroups in CheckMate 870OSMedian PFSa,mo (95% CI)ORRaMedian,mo (95% CI)6-mo rates (%)n (%)All treated (N = 400)NR (11.7–NR)753.7 (3.1–3.9)62 (16)HBV statusbNo HBV (n = 383)NR (11.6–NR)753.7 (3.1–3.9)59 (15)With HBV (n = 17)NR (10.0–NR)822.0 (1.6–NR)3 (18)EGFR mutation statuscPositive (n = 34)NR (9.6–NR)851.9 (1.7–3.6)5 (15)Not detected (n = 261)NR (11.4–NR)743.6 (2.7–3.9)37 (14)Tumor histologyNon-squamous (n = 264)NR (11.5–NR)763.4 (2.1–3.8)37 (14)Squamous (n = 136)NR (10.5–NR)724.7 (3.1–5.6)25 (18)Tumor PD-L1 expressiond≥ 1% (n = 169)NR (11.7–NR)745.4 (3.7–5.6)42 (25)< 1% (n = 174)13.2 (10.9–NR)773.1 (2.0–3.8)15 (9)Minimum follow up was 10 mo.aPer investigator;bHBV status is a protocol pre-specified enrollment cohort; the number of pts with HBV entering the study was capped at 60 (15% of the total population);cThe number of pts entering the study with EGFR mutations was capped at 40;dOf all treated patients, 343 (86%) were evaluable for tumor PD-L1 expression level. NR, not reached. Citation Format: Shun Lu, Ying Cheng, Jianying Zhou, Mengzhao Wang, Jun Zhao, Gongyan Chen, Baocheng Wang, Jifeng Feng, Zhiyong Ma, Lin Wu, Changli Wang, Shucai Zhang, Kewei Ma, Jun Liang, Yong Song, Jie Wang, Yi-Long Wu, Ang Li, Ting Ma, Jianhua Chang. Flat-dose nivolumab (NIVO) as second-line (2L) treatment (tx) for Asian patients (pts) with advanced non-small cell lung cancer (NSCLC): CheckMate 870 [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT218.