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Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies
Phase 1 trial testing Zanubrutinib in Lymphoma in 75 participants. Completed in 18 December 2020.
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 29 June 2016 |
| Primary completion | 18 December 2020 |
| Estimated completion | 18 December 2020 |
| Sites | 10 locations across China, Australia |
BeiGene — full company profile →
18 and older, any sex, with Lymphoma or Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The MTD of tislelizumab is considered the dose level below that at which at least 2 participants (or at least 33%) experience a dose-limiting toxicity (DLT).
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation Phase | NA |
The RP2D of tislelizumab in combination with zanubrutinib will be selected by taking into account the safety, tolerability, and pharmacokinetic (PK) profile.
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation Phase | 200 |
A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date during the treatment emergent period, defined as from the first dose date of zanubrutinib or tislelizumab (whichever is earlier) through 30 days after the last dose (permanent discontinuation of study drug) of zanubrutinib or 90 days after the last dose of tislelizumab, whichever is later, or prior to initiation of new anti-cancer therapy. Treatment-related serious adverse events (SAEs) and any worsening of a TEAE by PT post treatment-emergent period were also counted as TEAEs.
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 2.0 mg/kg Q3W | 15 | |
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 5.0 mg/kg Q3W | 9 | |
| Dose Escalation: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 7 | |
| Dose Expansion: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 40 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 2.0 mg/kg Q3W | 10 | |
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 5.0 mg/kg Q3W | 10 | |
| Dose Escalation: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 4 | |
| Dose Expansion: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 23 |
ORR, is defined as the percentage of participants who had complete response (CR) or partial response (PR) by standard disease-specific response criteria. for WM participants ORR includes minor response (MR) and very good partial response (VGPR).
| Group | Value | 95% CI |
|---|---|---|
| Other B-Cell Malignancies | 37.5 | 15.2 – 64.6 |
| GCB DLBCL | 25.0 | 5.5 – 57.2 |
| Non-GCB DLBCL | 40.0 | 16.3 – 67.7 |
| Richter's Transformation | 42.9 | 9.9 – 81.6 |
| Transformed Lymphoid Malignancy | 40 | 19.1 – 63.9 |
| PCNSL or SCNSL of Breast or Testicular Origin | 40 | 5.3 – 85.3 |
DOR is defined as the time from the date that a confirmed objective response is first documented to the date of progressive disease (PD) or death due to any cause for those participants with a confirmed PR or CR.
| Group | Value | 95% CI |
|---|---|---|
| Other B-Cell Malignancies | 22.36 | 7.72 – NA |
| GCB DLBCL | NA | NA – NA |
| Non-GCB DLBCL | 6.79 | 2.36 – NA |
| Richter's Transformation | 17.47 | 2.96 – NA |
| Transformed Lymphoid Malignancy | 8.89 | 2.83 – NA |
| PCNSL or SCNSL of Breast or Testicular Origin | 7.80 | 7.06 – 8.55 |
PFS, is defined as the time from the first dose of study medication to objective disease progression or death
| Group | Value | 95% CI |
|---|---|---|
| Other B-Cell Malignancies | 16.94 | 5.39 – NA |
| GCB DLBCL | 1.43 | 0.57 – NA |
| Non-GCB DLBCL | 2.80 | 1.43 – 6.99 |
| Richter's Transformation | 2.93 | 2.43 – 20.33 |
| Transformed Lymphoid Malignancy | 4.68 | 1.26 – 8.52 |
| PCNSL or SCNSL of Breast or Testicular Origin | 8.42 | 0.33 – 16.07 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 2.0 mg/kg Q3W | 0 | |
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 5.0 mg/kg Q3W | 0 | |
| Dose Escalation: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 0 | |
| Dose Expansion: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 2.0 mg/kg Q3W | 0 | |
| Dose Escalation: Zanubrutinib 320 mg QD + Tislelizumab 5.0 mg/kg Q3W | 0 | |
| Dose Escalation: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 0 | |
| Dose Expansion: Zanubrutinib 160 mg BID + Tislelizumab 200 mg Flat Q3W | 0 |
Time frame: From the Day of first dose of study drug until end of Study (up to 4 years and 6 months). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Escalation: Zanubruti… | Dose Escalation: Zanubruti… | Dose Escalation: Zanubruti… | Dose Expansion: Zanubrutin… |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Urosepsis | Infections and infestations | — | — | — | — |
| Haemolytic transfusion reaction | Injury, poisoning and procedural complications | — | — | — | — |
| Subdural haematoma | Injury, poisoning and procedural complications | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Atypical haemolytic uraemic syndrome | Blood and lymphatic system disorders | — | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Ulcerative keratitis | Eye disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Colitis microscopic | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Immune-mediated enterocolitis | Gastrointestinal disorders | — | — | — | — |
| Melaena | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Catheter site haemorrhage | General disorders | — | — | — | — |
| Immune-mediated hepatitis | Hepatobiliary disorders | — | — | — | — |
| Drug hypersensitivity | Immune system disorders | — | — | — | — |
| Reaction | System | Dose Escalation: Zanubruti… | Dose Escalation: Zanubruti… | Dose Escalation: Zanubruti… | Dose Expansion: Zanubrutin… |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Oral candidiasis | Infections and infestations | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness postural | Nervous system disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Urinary retention | Renal and urinary disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
Most-reported serious reactions: Haematuria, Febrile neutropenia, Multiple organ dysfunction syndrome, Pyrexia, Pneumonia, Urosepsis, Haemolytic transfusion reaction, Subdural haematoma.
Data from ClinicalTrials.gov NCT02795182 adverse events section.
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with BGB-A317 in participants with B-cell lymphoid malignancies.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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