Trial Outcomes & Findings for Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT04318080)

Last Updated: 2025-09-24

Results Overview

ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Results posted on

2025-09-24

Participant Flow

This study was conducted at multiple centers across France, the United States, Belgium, and Australia from August 20, 2020, to August 29, 2024.

After enrollment, open-label tislelizumab treatment began. Screening was completed within 28 days before the first dose. Treatment started within 14 days of eligibility confirmation, within the screening window. Treatment continued until disease progression, unacceptable toxicity, or withdrawal. Participants who did not meet eligibility criteria during screening were excluded prior to assignment to treatment groups.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
Overall Study STARTED	15	31
Overall Study Treated	14	31
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	15	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
Overall Study Study closed by sponsor	10	22
Overall Study Death	3	9
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Deviation	1	0

Baseline Characteristics

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=14 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=31 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total n=45 Participants Total of all reporting groups
Age, Continuous	43.9 Years STANDARD_DEVIATION 15.78 • n=5 Participants	59.6 Years STANDARD_DEVIATION 21.95 • n=7 Participants	54.7 Years STANDARD_DEVIATION 21.37 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	11 Participants n=5 Participants	26 Participants n=7 Participants	37 Participants n=5 Participants
Patient Status at Time of Enrollment Refractory	0 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants
Patient Status at Time of Enrollment Relapse/Progression	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
The Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Normal activities)	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
The Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Ambulatory able to carry out work)	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Number of prior lines of therapy for cHL 1	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Number of prior lines of therapy for cHL 2	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Number of prior lines of therapy for cHL 3	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Number of prior lines of therapy for cHL 4	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Cohort 1 n=14 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=31 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total n=45 Participants Participants received tislelizumab 200 mg intravenously every 3 weeks.
Overall Response Rate (ORR)	64.3 Percentage of Participants Interval 35.1 to 87.2	64.5 Percentage of Participants Interval 45.4 to 80.8	64.4 Percentage of Participants Interval 48.8 to 78.1

SECONDARY outcome

Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Population: Safety Analysis Set

CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected.

Outcome measures

Outcome measures
Measure	Cohort 1 n=14 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=31 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total n=45 Participants Participants received tislelizumab 200 mg intravenously every 3 weeks.
Complete Response Rate (CRR)	42.9 Percentage of Participants Interval 17.7 to 71.1	25.8 Percentage of Participants Interval 11.9 to 44.6	31.1 Percentage of Participants Interval 18.2 to 46.6

SECONDARY outcome

Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Population: The responder analysis set only included participants with a confirmed response (CR) or partial response (PR).

DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=20 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total n=29 Participants Participants received tislelizumab 200 mg intravenously every 3 weeks.
Duration of Response (DOR)	12.25 months Interval 5.55 to 12.25	6.64 months Interval 2.79 to Not estimable due to insufficient number of participants with events	12.25 months Interval 3.02 to Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Population: Safety Analysis Set. Only participants who had achieved an overall response were included in the analysis of time to response.

TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR.

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=20 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total n=29 Participants Participants received tislelizumab 200 mg intravenously every 3 weeks.
Time to Response (TTR)	2.69 months Interval 2.1 to 5.5	2.69 months Interval 0.3 to 5.6	2.69 months Interval 0.3 to 5.6

SECONDARY outcome

Timeframe: From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks)

Population: Safety Analysis set

Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported: Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade. Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity. Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose.

Outcome measures

Outcome measures
Measure	Cohort 1 n=14 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=31 Participants Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.	Total Participants received tislelizumab 200 mg intravenously every 3 weeks.
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of participants with any TEAEs	12 Participants	30 Participants	—
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of participants with any TEAEs with grade >= 3	4 Participants	12 Participants	—
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of participants with any SAEs	4 Participants	9 Participants	—

Adverse Events

Cohort 1

Serious events: 4 serious events

Other events: 12 other events

Deaths: 3 deaths

Cohort 2

Serious events: 9 serious events

Other events: 30 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: 1 877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 n=14 participants at risk Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.	Cohort 2 n=31 participants at risk Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
Gastrointestinal disorders Coeliac disease	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
General disorders Chest pain	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
General disorders Pyrexia	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Infections and infestations Peritonitis	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Infections and infestations Sepsis	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Investigations Alanine aminotransferase increased	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Investigations Aspartate aminotransferase increased	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Investigations Blood creatine phosphokinase increased	7.1% 1/14 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	0.00% 0/31 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Investigations Lipase increased	7.1% 1/14 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	0.00% 0/31 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Investigations Troponin increased	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.1% 1/14 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	0.00% 0/31 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous t-cell lymphoma	7.1% 1/14 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	0.00% 0/31 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	0.00% 0/31 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/14 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).	3.2% 1/31 • Number of events 1 • All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).