Trial Outcomes & Findings for A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL) (NCT NCT03595657)

NCT ID: NCT03595657

Last Updated: 2024-06-18

Results Overview

ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: From enrollment to end of follow-up, a median of 29 months
• Results posted on: 2024-06-18

Participant Flow

Participant milestones

Measure	R/R ENKTL Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Overall Study STARTED	80
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Measure	R/R ENKTL Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Overall Study Adverse Event	14
Overall Study Death	1
Overall Study Lack of Efficacy	40
Overall Study Withdrawal by Subject	10
Overall Study Dosing delayed over 9 weeks	1
Overall Study Achieved CR and completed 2 years of treatment	1

Baseline Characteristics

A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

Baseline characteristics by cohort

Measure	R/R ENKTL n=80 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	48.1 Years STANDARD_DEVIATION 12.68 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	80 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	80 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0	21 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1	59 Participants n=5 Participants
Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening Stage I	9 Participants n=5 Participants
Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening Stage II	17 Participants n=5 Participants
Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening Stage IV	54 Participants n=5 Participants
Epstein-Barr Virus (EBV) DNA at Screening Positive	44 Participants n=5 Participants
Epstein-Barr Virus (EBV) DNA at Screening Negative	36 Participants n=5 Participants
Baseline Bone Marrow Assessment Result Positive	5 Participants n=5 Participants
Baseline Bone Marrow Assessment Result Negative	73 Participants n=5 Participants
Baseline Bone Marrow Assessment Result Missing	2 Participants n=5 Participants
Central Pathology Confirmed ENKTL Yes	79 Participants n=5 Participants
Central Pathology Confirmed ENKTL No	1 Participants n=5 Participants
Patient Status Relapsed	43 Participants n=5 Participants
Patient Status Refractory	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Objective Response Rate (ORR) Assessed by IRRC	46.2 percentage of Participants Interval 34.8 to 57.8

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Objective Response Rate (ORR) Assessed by Investigators	45.6 Percentage of participants Interval 34.3 to 57.2

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Complete Response Rate (CRR) by Investigators	30.4 Percentage of participants Interval 20.5 to 41.8

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Complete Response Rate (CRR) Assessed by IRRC	37.2 Percentage of participants Interval 26.5 to 48.9

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Partial Response Rate (PRR) Assessed by Investigators	15.2 Percentage of participants Interval 8.1 to 25.0

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Partial Response Rate (PRR) Assessed by IRRC	9.0 Percentage of participants Interval 3.7 to 17.6

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Duration of Response (DoR) Assessed by Investigators	39.9 months Interval 14.8 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Duration of Response (DoR) Assessed by IRRC	35.2 months Interval 25.3 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Time to Response (TTR) Assessed by Investigators	2.8 months Interval 1.4 to 8.0

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Time to Response (TTR) Assessed by IRRC	2.8 months Interval 1.4 to 11.1

SECONDARY outcome

Timeframe: From enrollment to end of follow-up, a median of 29 months

Outcome measures

Measure	R/R ENKTL n=80 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Number of Participants With Adverse Events Treatment-Emergent Adverse Event (TEAE)	77 Participants
Number of Participants With Adverse Events Treatment-Related Adverse Event (TRAE)	63 Participants
Number of Participants With Adverse Events Serious Adverse Event (SAE)	22 Participants
Number of Participants With Adverse Events Related SAE	8 Participants
Number of Participants With Adverse Events ≥G3 TEAE	37 Participants
Number of Participants With Adverse Events ≥G3 TRAE	15 Participants
Number of Participants With Adverse Events Infusion-related Reaction	4 Participants
Number of Participants With Adverse Events TEAE of special interest	24 Participants
Number of Participants With Adverse Events TEAE of special interest grade 3-5	2 Participants
Number of Participants With Adverse Events TEAE Leading to Death	5 Participants
Number of Participants With Adverse Events TEAE Leading to Drug Permanently Discontinued	14 Participants
Number of Participants With Adverse Events TEAE Leading to Infusion Interruption	4 Participants
Number of Participants With Adverse Events TEAE Leading to Treatment Cycle Delay	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: one patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
6-months Progression-free Survival (PFS) Rate Assessed by Investigators	39.1 Percentage of participants Interval 28.1 to 49.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Outcome measures

Measure	R/R ENKTL n=78 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
6-months PFS Rate Assessed by IRRC	49.7 percentage of participants Interval 38.0 to 60.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

Outcome measures

Measure	R/R ENKTL n=79 Participants Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
6-month Overall Survival (OS) Rate	79.2 Percentage of participants Interval 68.3 to 86.7

Adverse Events

R/R ENKTL

Serious events: 22 serious events

Other events: 76 other events

Deaths: 37 deaths

Serious adverse events

Measure	R/R ENKTL n=80 participants at risk Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Blood and lymphatic system disorders Febrile neutropenia	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Cardiac disorders Sinus node dysfunction	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Ear and labyrinth disorders Deafness bilateral	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Duodenal perforation	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Intestinal obstruction	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Stomatitis	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
General disorders Death	2.5% 2/80 • From enrollment to end of follow-up, a median of 29 months
General disorders Pyrexia	3.8% 3/80 • From enrollment to end of follow-up, a median of 29 months
Hepatobiliary disorders Hepatic function abnormal	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Immune system disorders Haemophagocytic lymphohistiocytosis	2.5% 2/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Fungaemia	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Lower respiratory tract infection	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Pneumonia	6.2% 5/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Septic shock	2.5% 2/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Soft tissue infection	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Injury, poisoning and procedural complications Ear injury	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Electrolyte imbalance	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Musculoskeletal and connective tissue disorders Myositis	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months
Psychiatric disorders Confusional state	1.2% 1/80 • From enrollment to end of follow-up, a median of 29 months

Other adverse events

Measure	R/R ENKTL n=80 participants at risk Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
Blood and lymphatic system disorders Anaemia	17.5% 14/80 • From enrollment to end of follow-up, a median of 29 months
Endocrine disorders Hyperthyroidism	6.2% 5/80 • From enrollment to end of follow-up, a median of 29 months
Endocrine disorders Hypothyroidism	22.5% 18/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Constipation	11.2% 9/80 • From enrollment to end of follow-up, a median of 29 months
Gastrointestinal disorders Diarrhoea	8.8% 7/80 • From enrollment to end of follow-up, a median of 29 months
General disorders Pyrexia	31.2% 25/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations COVID-19	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Pneumonia	7.5% 6/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Upper respiratory tract infection	12.5% 10/80 • From enrollment to end of follow-up, a median of 29 months
Infections and infestations Urinary tract infection	12.5% 10/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Alanine aminotransferase increased	20.0% 16/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Aspartate aminotransferase increased	26.2% 21/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Blood bilirubin increased	7.5% 6/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Blood creatinine increased	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Blood thyroid stimulating hormone decreased	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Blood thyroid stimulating hormone increased	12.5% 10/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Haemoglobin decreased	6.2% 5/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Lymphocyte count decreased	16.2% 13/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Neutrophil count decreased	26.2% 21/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Platelet count decreased	13.8% 11/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Protein urine present	10.0% 8/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Thyroxine free decreased	7.5% 6/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Urinary occult blood positive	7.5% 6/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Urobilinogen urine increased	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Investigations Weight decreased	8.8% 7/80 • From enrollment to end of follow-up, a median of 29 months
Investigations White blood cell count decreased	31.2% 25/80 • From enrollment to end of follow-up, a median of 29 months
Investigations White blood cells urine positive	6.2% 5/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hyperglycaemia	12.5% 10/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hypertriglyceridaemia	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hyperuricaemia	10.0% 8/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 5/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hypocalcaemia	8.8% 7/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hypochloraemia	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hypokalaemia	8.8% 7/80 • From enrollment to end of follow-up, a median of 29 months
Metabolism and nutrition disorders Hyponatraemia	10.0% 8/80 • From enrollment to end of follow-up, a median of 29 months
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Nervous system disorders Hypoaesthesia	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Psychiatric disorders Insomnia	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Renal and urinary disorders Proteinuria	8.8% 7/80 • From enrollment to end of follow-up, a median of 29 months
Respiratory, thoracic and mediastinal disorders Cough	7.5% 6/80 • From enrollment to end of follow-up, a median of 29 months
Skin and subcutaneous tissue disorders Pruritus	5.0% 4/80 • From enrollment to end of follow-up, a median of 29 months
Skin and subcutaneous tissue disorders Rash	13.8% 11/80 • From enrollment to end of follow-up, a median of 29 months

Additional Information

Zhang Wenyun

CStone Pharmaceuticals

Phone: +86 021-60333416

Email: CstoneRA@cstonepharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee If the sponsor has not published trial results within 18 months since trial completion, the PI is allowed to publish data collected at the corresponding site. The PI should provide draft publication to the sponsor to review prior to distribution to any external parties; the sponsor should provide review comments to the PI within 60 calendar days since receipt of draft publication; the sponsor also has rights to postpone publication for up to 6 months based on reasonable grounds.
• Publication restrictions are in place

Restriction type: OTHER