Final overall survival analysis of JUPITER-02: A phase 3 study of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).

Authors

null

Hai-Qiang Mai

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China

Hai-Qiang Mai , Qiu-Yan Chen , Dong-Ping Chen , Chaosu Hu , Kunyu Yang , Jiyu Wen , Jin-Gao Li , Yingrui Shi , Feng Jin , Ruilian Xu , Jian-ji Pan , Shenhong Qu , Ping Li , Chunhong Hu , Yi-Chun Liu , Yi Jiang , Xia He , Hung-Ming Wang , Darren Wan-Teck Lim , Rui-Hua Xu

Organizations

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China, Sun Yat-sen University Cancer Center, Guangzhou, China, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China, Fudan University Cancer Center, Shanghai, China, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China, Jiangxi Cancer Hospital, Nanchang, China, Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China, The doctoral research start-up fund project of the affiliated hospital of Guizhou Medical University, Guiyang, Guizhou, China, Shenzhen People’s Hospital, The Secondary Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, China, Fujian Cancer Hospital, China, Fuzhou, China, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China, West China Hospital, Sichuan University, Chengdu, China, The Second Xiangya Hospital of Central South University, Changsha, China, Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan, Cancer Hospital of Shantou University Medical College, Shantou, China, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China, Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan, National Cancer Centre Singapore, Singapore, Singapore, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, China

Research Funding

Other
Shanghai Junshi Biosciences

Background: There are currently no FDA-approved IO therapies for NPC. Toripalimab in combination with Gemcitabine-Cisplatin (GP) chemotherapy had shown significant improvement over chemotherapy alone in progression-free survival (PFS) as first-line treatment for recurrent or metastatic (r/m) NPC at the interim PFS analysis of JUPITER-02 (NCT03581786) study. The final overall survival (OS) analysis results are summarized here. Methods: Patients with r/m NPC (n = 289) were randomized (1:1) to receive toripalimab 240 mg (n = 146) or placebo (n = 143) in combination with GP once every 3 weeks (Q3W) for up to 6 cycles, followed by monotherapy with toripalimab or placebo Q3W until disease progression, intolerable toxicity, or completion of 2 years of treatment. Stratification factors were ECOG performance score (0 vs. 1) and extent of disease (recurrent vs. primary metastatic) at enrollment. The primary endpoint was PFS by an independent review committee. Secondary endpoints included OS and safety. Results: By the cutoff date of Nov 18, 2022, when 133 events were reached for the final OS analysis, the median survival follow up was 30.1 months. A significant improvement in OS was observed for the toripalimab arm over the placebo arm: HR = 0.63 (95% CI: 0.45-0.89), two-sided p = 0.0083. The median OS was not reached in the toripalimab arm and was 33.7 months in the placebo arm. The 2-year and 3-year OS rates were 78.0% vs. 65.1%, and 64.5% vs. 49.2% respectively. A consistent effect on OS, favoring the toripalimab arm, was observed in nearly all subgroups, including PD-L1 high and PD-L1 low expression subgroups. No new safety signals were identified in the toripalimab arm since the interim report. The incidence of Grade ≥3 adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) were similar between two arms. However, AEs leading to discontinuation of toripalimab/placebo (11.6% vs 4.9%), immune-related (irAEs) (54.1% vs. 21.7%) and Grade ≥3 irAEs (9.6% vs. 1.4%) were more frequent in the toripalimab arm. Conclusions: The addition of toripalimab to GP chemotherapy as 1st-line treatment for r/m NPC provided clinically important and highly significant OS advantage over GP alone with a manageable safety profile. These results support the use of toripalimab with GP chemotherapy as the new standard care for this population. Clinical trial information: NCT03581786.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Advanced/Metastatic Disease

Clinical Trial Registration Number

NCT03581786

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 6009)

DOI

10.1200/JCO.2023.41.16_suppl.6009

Abstract #

6009

Poster Bd #

1

Abstract Disclosures