Trial Outcomes & Findings for Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (NCT NCT03829969)

NCT ID: NCT03829969

Last Updated: 2025-07-23

Results Overview

To evaluate the differences in PFS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 514 participants
• Primary outcome timeframe: PFS: up to 2years
• Results posted on: 2025-07-23

Participant Flow

Participant milestones

Measure	Toripalimab Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
Overall Study STARTED	257	257
Overall Study COMPLETED	257	257
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma

Baseline characteristics by cohort

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Total n=514 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	156 Participants n=5 Participants	163 Participants n=7 Participants	319 Participants n=5 Participants
Age, Categorical >=65 years	101 Participants n=5 Participants	94 Participants n=7 Participants	195 Participants n=5 Participants
Age, Continuous	61.30 years STANDARD_DEVIATION 8.04 • n=5 Participants	60.90 years STANDARD_DEVIATION 7.30 • n=7 Participants	61.1 years STANDARD_DEVIATION 7.67 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	217 Participants n=5 Participants	220 Participants n=7 Participants	437 Participants n=5 Participants
Race/Ethnicity, Customized Asian	257 Participants n=5 Participants	257 Participants n=7 Participants	514 Participants n=5 Participants
Region of Enrollment China	257 participants n=5 Participants	257 participants n=7 Participants	514 participants n=5 Participants

PRIMARY outcome

Timeframe: PFS: up to 2years

To evaluate the differences in PFS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review [BICR] per RECIST 1.1 criteria).

Outcome measures

Measure	Toripalimab n=132 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=164 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
PFS((Progression-Free Surviv)	5.7 months Interval 5.6 to 7.0	5.5 months Interval 5.2 to 5.6

PRIMARY outcome

Timeframe: up to 2 years

To evaluate the differences in OS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review [BICR] per RECIST 1.1 criteria)

Outcome measures

Measure	Toripalimab n=172 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=195 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
OS (Overall Survival)	17.7 months Interval 14.6 to 20.8	12.9 months Interval 11.6 to 14.1

SECONDARY outcome

Timeframe: Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed overall response rate (ORR), daccording to RECIST v1.1; ORR:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
ORR(Overall Response Rate:BICR)	178 Participants	134 Participants

SECONDARY outcome

Timeframe: Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed disease control rate (DCR) according to RECIST v1.1 DCR is defined as the proportion of patients with the best efficacy of CR or PR or SD.

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
DCR(Disease Control Rate:BICR )	229 Participants	211 Participants

SECONDARY outcome

Timeframe: Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed duration of response (DoR) according to RECIST v1.1 DOR is defined as the time from first documented response to first documented evidence of disease progression or to death, whichever comes first.

Outcome measures

Measure	Toripalimab n=178 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=134 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
DOR(Duration of Response: Recist 1.1,BICR )	5.6 months Interval 4.4 to 8.7	4.2 months Interval 4.2 to 4.4

SECONDARY outcome

Timeframe: Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed Time to initial Response (TTR) according to RECIST v1.1 TTR is defined as the time from randomization to the first recorded response (CR or PR).

Outcome measures

Measure	Toripalimab n=178 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=134 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
TTR(Time to Initial Response:BICR )	1.4 months Interval 1.4 to 1.5	1.4 months Interval 1.4 to 1.4

SECONDARY outcome

Timeframe: Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy，as measured by investigator-assessed progression free survival (PFS) according to RECIST v1.1

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
PFS	128 Participants	167 Participants

SECONDARY outcome

Timeframe: Up to 1 years

1 years PFS rate

Outcome measures

Measure	Toripalimab n=132 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=164 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
PFS Rate:BICR	27.8 Percentage of Participants Interval 20.4 to 35.8	6.1 Percentage of Participants Interval 2.2 to 12.6

SECONDARY outcome

Timeframe: up to 2 years

2 years OS rate

Outcome measures

Measure	Toripalimab n=172 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=195 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
OS Rate	39.1 Percentage of Participants Interval 33.1 to 45.0	27.1 Percentage of Participants Interval 21.7 to 32.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
PFS Assessed Per irRECIST	128 Participants	160 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
ORR Assessed Per irRECIST	180 Participants	136 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Toripalimab n=180 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=136 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
DoR Assessed Per irRECIST:BICR	5.6 months Interval 4.4 to 8.7	4.2 months Interval 4.2 to 4.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Toripalimab n=257 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
DCR Assessed Per irRECIST	232 Participants	218 Participants

SECONDARY outcome

Timeframe: 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 TTR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST

Outcome measures

Measure	Toripalimab n=180 Participants Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=136 Participants Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
TTR Assessed Per irRECIST:BICR	1.4 months Interval 1.4 to 1.5	1.4 months Interval 1.4 to 1.4

SECONDARY outcome

Timeframe: 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 quality of life (QoL) following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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 quality of life (QoL) following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized population.

Outcome measures

Outcome data not reported

Adverse Events

Toripalimab

Serious events: 93 serious events

Other events: 255 other events

Deaths: 174 deaths

Placebo

Serious events: 74 serious events

Other events: 255 other events

Deaths: 198 deaths

Serious adverse events

Measure	Toripalimab n=257 participants at risk Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 participants at risk Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
Gastrointestinal disorders Gastrointestinal disorder	10.1% 26/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	9.7% 25/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Blood and lymphatic system disorders Blood and lymphatic system disorders	7.4% 19/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	5.4% 14/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Infections and infestations Infectious and infectious	7.8% 20/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	3.5% 9/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
General disorders General disorders	6.6% 17/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	5.1% 13/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Respiratory, thoracic and mediastinal disorders Respiratory ,thoracic and mediastinal disorders	6.2% 16/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	4.7% 12/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Metabolism and nutrition disorders Metabolism and nutrition disorders	1.9% 5/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	3.9% 10/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Hepatobiliary disorders Hetapobiliary disorders	3.1% 8/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	1.9% 5/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Injury, poisoning and procedural complications Injury，poisoning and procedural complications	1.6% 4/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.78% 2/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Skin and subcutaneous tissue disorders Sikn and subcutaneous tissue disorders	1.6% 4/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.39% 1/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Cardiac disorders Cardica disorders	1.9% 5/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.39% 1/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Investigations Investigations	1.2% 3/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.39% 1/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Renal and urinary disorders Renal and urinary disorders	1.6% 4/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.39% 1/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Vascular disorders Vascular disorders	1.2% 3/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.78% 2/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Nervous system disorders Nervous system disorders	1.2% 3/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	1.9% 5/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Endocrine disorders Endorcrine disorders	1.6% 4/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.00% 0/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Immune system disorders Immune system disorders	0.39% 1/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.00% 0/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date

Other adverse events

Measure	Toripalimab n=257 participants at risk Toripalimab combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy	Placebo n=257 participants at risk Placebo combine with paclitaxel and cisplatin Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
Blood and lymphatic system disorders Blood and lymphatic system disorders	91.1% 234/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	88.7% 228/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Gastrointestinal disorders gastrointestinal disors	78.2% 201/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	78.6% 202/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Metabolism and nutrition disorders Metabolism and nutrition disorders	73.5% 189/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	75.5% 194/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Investigations Investigations	64.6% 166/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	59.1% 152/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
General disorders General disorders	64.6% 166/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	59.1% 152/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	53.3% 137/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	47.1% 121/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Nervous system disorders Nervous system disorders	45.9% 118/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	47.5% 122/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Respiratory, thoracic and mediastinal disorders Respiratory，thoracic and mediastinal disorders	40.5% 104/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	31.9% 82/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Musculoskeletal and connective tissue disorders Musculoskeletal and connective disorders	31.5% 81/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	30.0% 77/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Infections and infestations Infections and infestations	26.8% 69/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	20.6% 53/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Renal and urinary disorders Renal and urinary disorders	19.5% 50/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	20.2% 52/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Cardiac disorders Cardiac disorders	16.0% 41/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	8.2% 21/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Psychiatric disorders Psychiatric disorders	13.6% 35/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	11.7% 30/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Vascular disorders Vascular disorders	12.8% 33/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	13.6% 35/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Endocrine disorders Endocrine disorders	16.7% 43/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	8.6% 22/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Hepatobiliary disorders Hepatobiliary disorders	7.8% 20/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	5.8% 15/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Injury, poisoning and procedural complications Injury，poisoning and procedural complications	3.9% 10/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	2.3% 6/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Ear and labyrinth disorders Ear and labyrinth disorders	3.1% 8/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	2.3% 6/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Immune system disorders Immune system disorders	3.5% 9/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	3.1% 8/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Reproductive system and breast disorders Reproductive system and breast disorders	2.3% 6/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	0.78% 2/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Eye disorders Eye disorders	1.9% 5/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	1.2% 3/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign，malignant and unspecified（incl cysts and polys）	2.3% 6/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date	3.1% 8/257 • Up to approximately 49 months Safety data are based on the 23 February 2023 cut-off date

Additional Information

Huimei Xie

Shanghai Junshi Bioscience Co., Ltd.

Phone: 86-021-50796193

Email: huimei_xie@junshipharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place