According to the latest clinical trial data of the CheckMate-078 (NCT02613507, CTR20150767) of Opdivo (nivolumab) conducted among the Chinese lung cancer patients published by BMS on April 13, Opdivo could significantly benefit the overall survival (HR 0.68, p=0.0006) of Chinese patients with previously treated non-small cell lung cancer (NSCLC) compared to docetaxel, and the results will be reported orally at AACR Annual Meeting 2018 on April 16. Currently, BMS’ nivolumab, MSD’s pembrolizumab, and Junshi Biosciences’ teruipuli monoclonal antibody are in the first echelon of anti-PD-(L)1 antibody marketing in China, and BMS’ Opdivo is very likely to become the first anti-PD-(L)1 antibody to enter China.
I. Update on review progress of the 3 anti-PD-(L)1 antibodies
BMS took the lead in applying for marketing of nivolumab in China on November 1, 2017, to formally start the marketing process in China, which is expected to be formally approved in the second half of 2018.
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S/N
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Acceptance No.
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Pharmaceutical product name
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Time of entering CDE
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Indication
|
Pharmacology and toxicology
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Clinical data
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Pharmacy
|
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11
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JXSS1700015
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Nivolumab注射液
Nivolumab injection
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2017-11-01
November 1, 2017
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經治NSCLC
Previously treated NSCLC
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完成
Completed
|
完成
Completed
|
待審評
To be reviewed
|
|
12
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JXSS1700016
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Nivolumab注射液
Nivolumab injection
|
2017-11-01
November 1, 2017
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經治NSCLC
Previously treated NSCLC
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完成
Completed
|
完成
Completed
|
待審評
To be reviewed
|
|
31
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JXSS1800002
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帕博利珠單抗注射液
Pembrolizumab injection
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2018-02-11
February 11, 2018
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黑色素瘤
Melanoma
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待審評
To be reviewed
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待審評
To be reviewed
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待審評
To be reviewed
|
|
37
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CXSS1800006
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特瑞普利單抗注射液
Teruipuli monoclonal antibody injection
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2018-03-20
March 20, 2018
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黑色素瘤
Melanoma
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待審評
To be reviewed
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待審評
To be reviewed
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待審評
To be reviewed
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According to the official information of CDE, nivolumab injection entered CDE on November 1, 2017, and has been completed pharmacology and toxicology and clinical data review, with the pharmacy to be reviewed. MSD’s pembrolizumab and Junshi Biosciences’ teruipuli monoclonal antibody have successively entered CDE, and are queuing for review.
II. Previously treated NSCLC: all data of CheckMate-078 clinical trial published
BMS published the analysis results of the independent Data Monitoring Committee (DMC) on CheckMate-078 on November 30, 2017: the clinical trial met the primary endpoint of overall survival, and the trial was completed in advance.
CheckMate -078 was a Phase 3, randomized, and multicenter clinical trial mainly conducted among the Chinese population, evaluating nivolumab versus docetaxel in previously treated advanced or metastatic NSCLC in terms of safety and effectiveness, with the corresponding clinical acceptance No. of JXSL1300032.
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NCT02613507
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Nivolumab
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Docetaxel
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Patient information
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Relapsed NSCLC (Stage IIIb/IV) after platinum-based doublet chemotherapy; 451 Chinese patients, 45 Russian patients, and 8 Singaporean patients, randomized 2:1;
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Medication regimen
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Injection; specification: 100mg (10mg/mL)/bottle, 3mg/kg, day 1 of each treatment cycle, I.V., Q2W, 60min for each infusion. Medication length: continuous infusion until documented disease progression or unacceptable toxicity.
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Injection; specification: 20mg (1.5mL/bottle), 75mg/m2, day 1 of each treatment cycle, I.V., Q3W, 60min for each infusion. Medication length: continuous infusion until documented disease progression or unacceptable toxicity.
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Primary endpoint
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Overall survival (OS); HR 0.68; 97.7% CI [0.52-0.90], p=0.0006
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ORR
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17%
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4%
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Duration of response (DOR)
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Not met
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5.3 months
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|
PFS
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Disease progression risk lowered by 23%, HR 0.77; 95% CI [0.62, 0.95], p=0.0147
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Severe adverse event (grade 3-4) rate
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10%
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47%
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According to CheckMate-078, compared to docetaxel, Opdivo could significantly benefit the overall survival (HR 0.68, p=0.0006) of Chinese patients with previously treated NSCLC, and lower disease progression risk, with statistically significant clinical benefits, being consistent with the overall survival data of CheckMate-017 and CheckMate-057.
Furthermore, in the analysis of different subgroups based on histological classification and PD-L1 level, Opdivo could extend the overall survival of patients in each subgroup. See the following table for the detailed data:
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Analysis of different subgroups-
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Opdivo group
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Docetaxel group
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Histology
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Squamous NSCLC
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HR 0.61, 95% CI [0.42, 0.89]
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Non-squamous NSCLC
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HR 0.76, 95% CI [0.56, 1.04]
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PD-L1 level
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PD-L1 negative
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HR 0.75, 95% CI [0.52, 1.09]
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PD-L1 positive
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HR 0.62, 95% CI [0.45, 0.87]
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Additional data:
1. Summary of information of some CheckMate trials:
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CheckMate
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Status
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Indication
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Drug
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Clinical stage
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NCT
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CheckMate 067
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Active, not recruiting
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•Unresectable or Metastatic Melanoma
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|
•Biological: Nivolumab
|
|
•Biological: Ipilimumab
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|
•Biological: Placebo for Nivolumab
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|
•Biological: Placebo for Ipilimumab
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|
Phase 3
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NCT01844505
|
|
CheckMate 037
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Active, not recruiting
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•Unresectable or Metastatic Melanoma
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•Biological: BMS-936558
•Drug: Dacarbazine
•Drug: Carboplatin
•Drug: Paclitaxel
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Phase 3
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NCT01721746
|
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CheckMate 066
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Active, not recruiting
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•Melanoma
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|
•Biological: BMS-936558 (Nivolumab)
|
|
•Biological: Placebo matching
BMS-936558 (Nivolumab)
|
|
•Drug: Dacarbazine
|
|
•Drug: Placebo matching Dacarbazine
|
|
Phase 3
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NCT01721772
|
|
Checkmate 017
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Active, not recruiting
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•Squamous Cell Non- small Cell Lung Cancer
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•Biological: Nivolumab
•Drug: Docetaxel
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Phase 3
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NCT01642004
|
|
CheckMate
057
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Active, not recruiting
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•Non-Squamous Cell Non- small Cell Lung Cancer
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•Biological: Nivolumab
•Drug: Docetaxel
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Phase 3
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NCT01673867
|
|
Checkmate 025
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Active, not recruiting
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•Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
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•Biological: Nivolumab
•Drug: Everolimus
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Phase 3
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NCT01668784
|
|
CheckMate 205
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Active, not recruiting
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•Hodgkin Disease
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•Drug: Nivolumab
•Drug: Doxorubicin
•Drug: Vinblastine
•Drug: Dacarbazine
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Phase 2
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NCT02181738
|
|
CheckMate 039
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Active, not recruiting
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•Non-Hodgkin's •Lymphoma
•Hodgkin Lymphoma
•Multiple Myeloma
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•Biological: Nivolumab
•Biological: Ipilimumab
•Biological: Lirilumab
•Biological: Daratumumab
•Drug: Pomalidomide
•Drug: Dexamethasone
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Phase 1
|
NCT01592370
|
|
CheckMate 141
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Active, not recruiting
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•Squamous Cell Carcinoma of the Head and Neck
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•Drug: Nivolumab
•Drug: Cetuximab
•Drug: Methotrexate
•Drug: Docetaxel
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Phase 3
|
NCT02105636
|
|
CheckMate 275
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Active, not recruiting
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Various Advanced Cancer
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Drug: Nivolumab
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Phase 2
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NCT02387996
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|
CheckMate
040
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Recruiting
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•Hepatocellular Carcinoma
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•Biological: Nivolumab •Drug: Sorafenib •Drug: Ipilimumab •Drug: Cabozantinib
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Phase 1
|
NCT01658878
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2. List of information orally reported on Checkmate-078 at AACR Annual Meeting 2018
CT114 - Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer (NSCLC): results of the phase 3 CheckMate 078 study
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April 16, 2018, 4:05 PM - 4:20 PM
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N Hall C - McCormick Place North (Level 1)
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