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Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial

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机构： [1]Department of Nasopharyngeal Carcinoma, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou [2]Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China [3]Fudan University Cancer Center, Shanghai, China [4]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China [5]Affiliated Hospital of Guangdong Medical University, Zhanjiang, China [6]Jiangxi Cancer Hospital, Nanchang, China [7]Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China [8]The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China [9]Shenzhen People’s Hospital, Shenzhen, China [10]Fujian Provincial Cancer Hospital, Fuzhou, China [11]The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China [12]West China Hospital of Sichuan University, Chengdu [13]The Second Xiangya Hospital of Central South University, Changsha, China [14]Taichung Veterans General Hospital, Taichung, Taiwan [15]Cancer Hospital of Shantou University Medical College, Shantou, China [16]Jiangsu Cancer Hospital, Nanjing, China [17]Chang Gung Memorial Hospital, Taoyuan, Taiwan [18]National Cancer Centre, Singapore City, Singapore [19]Nanfang Hospital, Guangzhou, China [20]Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing [21]Zhejiang Cancer Hospital, Hangzhou, China [22]The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, China [23]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan, China [24]Shanghai General Hospital, Shanghai, China [25]Fujian Medical University Union Hospital, Fuzhou, China [26]The Fourth Hospital of Hebei Medical University Hebei Cancer Hospital, Shijiazhuang, China [27]Hainan General Hospital, Haikou, China [28]LiuzhouWorker’s Hospital, Liuzhou, China [29]China Medical University Hospital, Taichung, Taiwan [30]Taipei Veterans General Hospital, Taipei, Taiwan [31]National Cheng Kung University Hospital, Tainan, Taiwan [32]Tan Tock Seng Hospital, Singapore City, Singapore [33]Shanghai Junshi Biosciences, Shanghai, China [34]TopAlliance Biosciences, Rockville, Maryland [35]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou

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There are currently no therapies approved by the US Food and Drug Administration for nasopharyngeal carcinoma (NPC). Gemcitabine-cisplatin is the current standard of care for the first-line treatment of recurrent or metastatic NPC (RM-NPC).To determine whether toripalimab in combination with gemcitabine-cisplatin will significantly improve progression-free survival and overall survival as first-line treatment for RM-NPC, compared with gemcitabine-cisplatin alone.JUPITER-02 is an international, multicenter, randomized, double-blind phase 3 study conducted in NPC-endemic regions, including mainland China, Taiwan, and Singapore. From November 10, 2018, to October 20, 2019, 289 patients with RM-NPC with no prior systemic chemotherapy in the RM setting were enrolled from 35 participating centers.Patients were randomized (1:1) to receive toripalimab (240 mg [n = 146]) or placebo (n = 143) in combination with gemcitabine-cisplatin for up to 6 cycles, followed by maintenance with toripalimab or placebo until disease progression, intolerable toxicity, or completion of 2 years of treatment.Progression-free survival as assessed by a blinded independent central review. Secondary end points included objective response rate, overall survival, progression-free survival assessed by investigator, duration of response, and safety.Among the 289 patients enrolled (median age, 46 [IQR, 38-53 years; 17% female), at the final progression-free survival analysis, toripalimab treatment had a significantly longer progression-free survival than placebo (median, 21.4 vs 8.2 months; HR, 0.52 [95% CI, 0.37-0.73]). With a median survival follow-up of 36.0 months, a significant improvement in overall survival was identified with toripalimab over placebo (hazard ratio [HR], 0.63 [95% CI, 0.45-0.89]; 2-sided P = .008). The median overall survival was not reached in the toripalimab group, while it was 33.7 months in the placebo group. A consistent effect on overall survival, favoring toripalimab, was found in subgroups with high and low PD-L1 (programmed death-ligand 1) expression. The incidence of all adverse events, grade 3 or greater adverse events, and fatal adverse events were similar between the 2 groups. However, adverse events leading to discontinuation of toripalimab or placebo (11.6% vs 4.9%), immune-related adverse events (54.1% vs 21.7%), and grade 3 or greater immune-related adverse events (9.6% vs 1.4%) were more frequent in the toripalimab group.The addition of toripalimab to chemotherapy as first-line treatment for RM-NPC provided statistically significant and clinically meaningful progression-free survival and overall survival benefits compared with chemotherapy alone, with a manageable safety profile. These findings support the use of toripalimab plus gemcitabine-cisplatin as the new standard of care for this patient population.ClinicalTrials.gov Identifier: NCT03581786.

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大类 | 1 区

医学

小类 | 1 区医学：内科

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

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Q1 MEDICINE, GENERAL & INTERNAL

最新[2023]版：

Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 63.1 最新[2023版] 66.8 最新五年平均 63.1 出版当年[2023版] 66.8 出版当年五年平均 120.7 出版前一年[2022版]

第一作者：

第一作者机构： [1]Department of Nasopharyngeal Carcinoma, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou [*1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, 651 Dong Feng Rd E, Guangzhou 510060, Guangdong Province, China.

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通讯作者：

通讯机构： [1]Department of Nasopharyngeal Carcinoma, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou [35]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou [*1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, 651 Dong Feng Rd E, Guangzhou 510060, Guangdong Province, China.

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