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A Phase II Study of Nivolumab Plus Gemcitabine in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (KCSG HN17-11)

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Author(s)
Hyun Ae JungKeon-Uk ParkSanghee ChoJinyeong LimKeun-Wook LeeMin Hee HongTak YunHo Jung AnWoong-Yang ParkSergio PereiraChan-Young OckBhumsuk Keam
Keimyung Author(s)
Park, Keon Uk
Department
Dept. of Internal Medicine (내과학)
Journal Title
Clin Cancer Res
Issued Date
2022
Volume
28
Issue
19
Abstract
Purpose:
Although programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors are promising agents for recurrent or metastatic nasopharyngeal carcinoma (NPC), PD-1/PD-L1 inhibitor monotherapy has shown modest efficacy. This study evaluated the efficacy and safety of nivolumab plus gemcitabine in patients with NPC who failed prior platinum-based chemotherapy.

Patients and Methods:
This is a phase II, multicenter, open-label, single-arm study. Patients with recurrent or metastatic NPC received nivolumab 3 mg/kg and gemcitabine 1,250 mg/m2 every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), overall survival (OS), and safety. To identify potential biomarkers, whole-exome sequencing, whole-transcriptome sequencing, and immune phenotype analysis based on Lunit SCOPE IO, an artificial intelligence–powered spatial tumor-infiltrating lymphocyte analyzer, were performed.

Results:
Thirty-six patients were enrolled between June 2018 and June 2019. The ORR was 36.1% and disease control rate was 97.2%. With median follow-up of 22.0 months, median PFS was 13.8 months [95% confidence interval (CI), 8.6–16.8 months]. Median OS was not reached, and OS rate at 6 months was 97.0% (95% CI, 80.4%–99.6%). The grade ≥3 treatment-related adverse events were hypertension (2.8%) and anemia (2.8%). In multivariate analysis of mutation of chromatin modifier gene, tumor mutational burden (≥ 2.1 mut/Mb), and somatic copy-number alteration (SCNA) level, the group with high SCNA (> 3 points; HR, 7.0; 95% CI, 1.3–37.9; P = 0.02) had independently associated with poor PFS. Immune phenotype analysis showed that tumors with high proportion of immune-excluded immune phenotype was significantly correlated with poor PFS (HR, 4.4; 95% CI, 1.2–16.2; P = 0.018).

Conclusions:
Nivolumab plus gemcitabine showed promising efficacy with favorable toxicity profiles in patients with advanced NPC in whom platinum-based combination chemotherapy failed.
Keimyung Author(s)(Kor)
박건욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1557-3265
Source
https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-1238/707906/A-Phase-II-Study-of-Nivolumab-plus-Gemcitabine-in
DOI
10.1158/1078-0432.CCR-22-1238
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44443
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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