党员整改清单A pha II umbrella study of camrelizumab in different PD-L1 expression cohorts in pre-treated advanced/metastatic NSCLC
Yi-Long Wu, MD
On behalf of Cheng Huang, Yun Fan, JiFeng Feng, Hong-ming Pan, Liyan Jiang, Jin-Ji Yang, Xing-Ya Li, Xiao-Qing Liu, Jiang-Ping Xiong, Yan-Qiu Zhao, Ying Cheng, Rui Ma, Jie Wang,Yi-Na Wang, Yan-Hui Liu, Dong-Mei Lin, Wei Shi, Xiang Lin Fujian Provincial Cancer Hospital;Zhejiang Cancer Hospital;Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Rearch&The Affiliated Cancer Hospital of Nanjing Medical University;Sir Run Run Shaw Hospital(SRRSH),affiliated with the Zhejiang University School of Medicine;Shanghai Chest Hospital,Shanghai Jiao Tong University;The First Affiliated Hospital of Zhengzhou University;The Fifth Medical Centre,Chine PLA General Hospital;The First Affiliated Hospital of Nanchang University;Henan Cancer hospital/Affiliated Cancer Hospital of Zhengzhou University;Jilin Cancer Hospital;Liaoning Cancer Hospital;National Cancer Center/Cancer Hospital,Chine Academy of Medical Sciences and Peking Union Medical College;The
First Affiliated Hospital,ZheJiang University;Peking University Cancer Hospital&Institute;Jiangsu Hengrui Medicine Co.Ltd.
头发染色Disclosures
Commercial Interest Relationship(s)
AstraZeneca Advisory Board, Honorarium,Consultant
Roche Advisory Board, Honorarium, Contracted/Support Rearch Grant, Consultant
BMS Advisory Board, Honorarium,Consultant
Eli Lilly Honorarium
Pfizer Honorarium
Boehringer Ingelheim Honorarium, Contracted/Support Rearch Grant
Backgrounds (1/3)
2nd line and beyond 1st line
NSCLC without oncogenic drivers; ECOG PS 0 or 1
PD-L1 <1% or unknown
•Platinum-doublet chemotherapy
•Bevacizumab + platinum-doublet chemotherapy •Gemcitabine + docetaxel/vinorelbine
•Pembrolizumab + platinum-doublet chemotherapy *
•Atezolizumab + carboplatin + paclitaxel + bevacizumab #
PD-L1 ≥1%
•Pembrolizumab
For patients with PD-L1 ≥1% who has not received
恋爱约会
platinum-doublet chemotherapy, refer to 1st line therapies
•Docetaxel •Pemetrexed #•Gemcitabine
•Ramucirumab + docetaxel
•Nivolumab
•Pembrolizumab •Atezolizumab
*for adenocarcinoma or large cell carcinoma: carboplatin/cisplatin + pemetrexed; for squamous cell carcinoma: carboplatin/cisplatin + paclitaxel/albumin-bound paclitaxel. #only for adenocarcinoma or large cell carcinoma.
Backgrounds (2/3)
The role of PD-L1 expression in 2nd line and beyond NSCLC remains controversial Trial Regimens Population PD-L1Median PFS (months)Median OS (months)
CheckMate-017[1]Nivolumab vs.
docetaxel
Squamous-cell NSCLC
<1% 3.1 vs. 3.08.7 vs. 5.9
≥1% 3.3 vs. 2.89.3 vs. 7.2
≥5% 4.8 vs. 3.110.0 vs. 6.4
≥10% 3.7 vs. 3.311.0 vs. 7.1
CheckMate-057 [2]Nivolumab vs.
docetaxel
Non-squamous NSCLC
<1% 2.1 vs. 3.610.5 vs. 10.1
≥1% 4.2 vs. 4.5 17.7 vs. 9.0
≥5% 5.0 vs. 3.819.4 vs. 8.1
脱欧公投
≥10% 5.0 vs. 3.719.9 vs. 8.0
CheckMate-078 [3]Nivolumab vs.
docetaxel
EGFR/ALK negative
NSCLC
˂1%..11.4 vs. 10.2
≥1%..12.3 vs. 7.9
KEYNOTE-010[4]Pembrolizumab vs.
docetaxel
NSCLC
≥1% 3.9 vs. 4.010.4 vs. 8.5
≥50% 5.0 vs. 4.114.9 vs. 8.2
POPLAR[5]Atezolizumab vs.
docetaxel
NSCLC
˂1% 1.7 vs. 4.19.7 vs. 9.7
≥1% 2.8 vs. 3.015.5 vs. 9.2
OAK[6]Atezolizumab vs.
docetaxel
宅男女神排行榜NSCLC
<1% 2.6 vs. 4.012.6 vs. 8.9
≥1% 2.8 vs. 4.115.7 vs. 10.3
Backgrounds (3/3)
Camrelizumab(SHR-1210)
•A lective,humanized anti–PD-1monoclonal antibody
•Promising anti-tumor activity and manageable safety profile in pretreated,advanced solid tumors(data on file).
▪18NSCLC patients
▪ORR was11.1%,and DCR was33.3%绿的近义词
百雀羚化妆品
•The relationship between PD-L1expression and efficacy not clear
<1%
≥1–<25%
≥25–<50%≥50%
Camrelizumab 200 mg,I.V., Q2W
Previously treated
advanced/metastatic NSCLC
孔颖达简介Study Design
☐Primary objective:
Efficacy of camrelizumab in different PD-L1 expression cohorts in Chine patients with previously treated advanced or metastatic NSCLC.☐Key eligibility criteria:
•Patients progresd during or following platinum-bad doublet chemotherapy.
•EGFR-or ALK-altered patients progresd on TKI and with ≥50%PD-L1expression in tumor.☐Primary endpoint:
Confirmed ORR
☐Secondary endpoints:
DoR, PFS, 12-month OS rate, and safety
TPS:PD-L1tumor proportion score;
ORR: objective respon rate; DoR: duration of respon; PFS: progression-free survival; OS, overall survival
DAKO 22C3
TPS
