Recurrent or Metastatic NPC
Conditions
Brief summary
This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.
Detailed description
Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).
Interventions
BIOLOGICALTORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
DRUGPlacebos
placebo combine with chemotherapy
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥ 18 years and ≤75 years. * 2\. Histological/cytological confirmation of NPC. * 3\. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment. * 4\. At least 1 measurable lesion according to RECIST version 1.1. * 5\. Life expectancy ≥ 3 months
Exclusion criteria
* 1\. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001. * 2\. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor. * 3\. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study * 4\. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients. * 5\. Female patients who are at pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 | up to 2 years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed ORR According to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. |
| Investigator-assessed DoR According to RECIST v1.1 | From date of response until progressive disease. Up to 2 approximately years | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1. |
| Investigator-assessed DCR According to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1. |
| Investigator-assessed PFS According to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1 |
| Investigator-assessed PFS Rate at 1 Year | up to approximately 1years | To evaluate the PFS rate at 1 year in each treatment arm by investigator |
| OS Rate at 1 Year | Up to approximately 1 years | To evaluate the OS rate at 1 year in each treatment arm |
| IRC-assessed ORR According to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35 |
| IRC-assessed DoR According to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1. |
| IRC-assessed DCR According to RECIST v1.1 | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1. |
| Number of Participants Experiencing an Adverse Event(AE) | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | Incidence of adverse events(AE) as assessed by CTCAE version 5.0 |
| OS | The time frame of OS collected is upto about 48months. | Overall survival was defined as the time from randomization to death from any cause. |
| PFS IRC-assessed Per irRECIST | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| ORR IRC-assessed Per irRECIST | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| DoR IRC-assessed Per irRECIST | From date of response until progressive disease. Up to 2 approximately years | To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| DCR IRC-assessed Per irRECIST | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Investigator-assessed PFS Rate at 2 Years | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the PFS rate at 2 years in each treatment arm by investigator |
| OS Rate at 2 Years | Up to approximately 2 years | To evaluate the OS rate at 2 years in each treatment arm |
| PFS Investigator-assessed Per irRECIST | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| ORR Investigator-assessed Per irRECIST | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| DoR Investigator-assessed Per irRECIST | From date of response until progressive disease. Up to 2 approximately years | To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| DCR Investigator-assessed Per irRECIST | Up to approximately 42 months | To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Anti-drug Antibody(ADA) | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | To evaluate the incidence of ADAs against JS001 |
Countries
China, Singapore, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Combine With Chemotherapy Placebos: placebo combine with chemotherapy | 143 |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy | 146 |
| Total | 289 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 67 | 47 |
| Overall Study | Lost to Follow-up | 7 | 4 |
| Overall Study | reason other than specified above | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Placebo Combine With Chemotherapy | TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 136 Participants | 139 Participants | 275 Participants |
| Age, Continuous | 49.68 years STANDARD_DEVIATION 10.355 | 45.84 years STANDARD_DEVIATION 11.26 | 47.74 years STANDARD_DEVIATION 10.973 |
| Race/Ethnicity, Customized Asian | 143 Participants | 146 Participants | 289 Participants |
| Region of Enrollment China | 134 participants | 136 participants | 270 participants |
| Region of Enrollment Singapore | 2 participants | 3 participants | 5 participants |
| Region of Enrollment Taiwan | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 49 Participants |
| Sex: Female, Male Male | 116 Participants | 124 Participants | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 67 / 143 | 47 / 146 |
| other Total, other adverse events | 143 / 143 | 146 / 146 |
| serious Total, serious adverse events | 62 / 143 | 64 / 146 |
Outcome results
Primary
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.
Time frame: up to 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 | 8.2 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 | 21.4 months |
Secondary
Anti-drug Antibody(ADA)
To evaluate the incidence of ADAs against JS001
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Population: ADA testing only was applicable for Toripalimab group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Combine With Chemotherapy | Anti-drug Antibody(ADA) | 0 Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Anti-drug Antibody(ADA) | 10 Participants |
Secondary
DCR Investigator-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: Up to approximately 42 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | DCR Investigator-assessed Per irRECIST | 90.9 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | DCR Investigator-assessed Per irRECIST | 91.1 Percentage of Participants |
Secondary
DCR IRC-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | DCR IRC-assessed Per irRECIST | 81.8 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | DCR IRC-assessed Per irRECIST | 88.4 Percentage of Participants |
Secondary
DoR Investigator-assessed Per irRECIST
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of response until progressive disease. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | DoR Investigator-assessed Per irRECIST | 5.9 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | DoR Investigator-assessed Per irRECIST | 16.0 months |
Secondary
DoR IRC-assessed Per irRECIST
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of response until progressive disease. Up to 2 approximately years
Population: NE below means not estimable
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | DoR IRC-assessed Per irRECIST | 5.9 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | DoR IRC-assessed Per irRECIST | 20.1 months |
Secondary
Investigator-assessed DCR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed DCR According to RECIST v1.1 | 90.9 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed DCR According to RECIST v1.1 | 91.1 Percentage of Participants |
Secondary
Investigator-assessed DoR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.
Time frame: From date of response until progressive disease. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed DoR According to RECIST v1.1 | 6.0 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed DoR According to RECIST v1.1 | 16.0 months |
Secondary
Investigator-assessed ORR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed ORR According to RECIST v1.1 | 75.5 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed ORR According to RECIST v1.1 | 82.2 Percentage of Participants |
Secondary
Investigator-assessed PFS According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed PFS According to RECIST v1.1 | 8.1 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed PFS According to RECIST v1.1 | 17.3 months |
Secondary
Investigator-assessed PFS Rate at 1 Year
To evaluate the PFS rate at 1 year in each treatment arm by investigator
Time frame: up to approximately 1years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed PFS Rate at 1 Year | 26.2 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed PFS Rate at 1 Year | 61.4 Percentage of Participants |
Secondary
Investigator-assessed PFS Rate at 2 Years
To evaluate the PFS rate at 2 years in each treatment arm by investigator
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | Investigator-assessed PFS Rate at 2 Years | 15.4 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Investigator-assessed PFS Rate at 2 Years | 37.0 Percentage of Participants |
Secondary
IRC-assessed DCR According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1.
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | IRC-assessed DCR According to RECIST v1.1 | 80.4 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | IRC-assessed DCR According to RECIST v1.1 | 88.4 Percentage of Participants |
Secondary
IRC-assessed DoR According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | IRC-assessed DoR According to RECIST v1.1 | 6.0 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | IRC-assessed DoR According to RECIST v1.1 | 18.0 months |
Secondary
IRC-assessed ORR According to RECIST v1.1
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | IRC-assessed ORR According to RECIST v1.1 | 67.1 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | IRC-assessed ORR According to RECIST v1.1 | 78.8 Percentage of Participants |
Secondary
Number of Participants Experiencing an Adverse Event(AE)
Incidence of adverse events(AE) as assessed by CTCAE version 5.0
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Combine With Chemotherapy | Number of Participants Experiencing an Adverse Event(AE) | 143 Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | Number of Participants Experiencing an Adverse Event(AE) | 146 Participants |
Secondary
ORR Investigator-assessed Per irRECIST
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | ORR Investigator-assessed Per irRECIST | 75.5 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | ORR Investigator-assessed Per irRECIST | 82.2 Percentage of Participants |
Secondary
ORR IRC-assessed Per irRECIST
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | ORR IRC-assessed Per irRECIST | 67.8 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | ORR IRC-assessed Per irRECIST | 78.8 Percentage of Participants |
Secondary
OS
Overall survival was defined as the time from randomization to death from any cause.
Time frame: The time frame of OS collected is upto about 48months.
Population: NE below means not estimable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | OS | 33.7 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | OS | NA months |
Secondary
OS Rate at 1 Year
To evaluate the OS rate at 1 year in each treatment arm
Time frame: Up to approximately 1 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | OS Rate at 1 Year | 87.1 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | OS Rate at 1 Year | 90.9 Percentage of Participants |
Secondary
OS Rate at 2 Years
To evaluate the OS rate at 2 years in each treatment arm
Time frame: Up to approximately 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Combine With Chemotherapy | OS Rate at 2 Years | 65.1 Percentage of Participants |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | OS Rate at 2 Years | 78.0 Percentage of Participants |
Secondary
PFS Investigator-assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | PFS Investigator-assessed Per irRECIST | 8.1 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | PFS Investigator-assessed Per irRECIST | 17.3 months |
Secondary
PFS IRC-assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Combine With Chemotherapy | PFS IRC-assessed Per irRECIST | 8.3 months |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | PFS IRC-assessed Per irRECIST | 21.6 months |