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A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Phase 2, PHASE3 trial testing Rituximab (RTX) in Diffuse Large B-cell Lymphoma in 453 participants. Completed in 21 June 2024.
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 453 |
| Start date | 28 November 2016 |
| Primary completion | 21 June 2024 |
| Estimated completion | 21 June 2024 |
| Sites | 158 locations across Italy, Finland, Taiwan, Poland, South Korea, Croatia, New Zealand, Portugal |
Incyte Corporation — full company profile →
18 and older, any sex, with Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 7.10 | 5.800 – 8.500 |
| Rituximab + Bendamustine | 8.30 | 5.600 – 11.500 |
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 5.60 | 4.400 – 8.600 |
| Rituximab + Bendamustine | 5.60 | 3.600 – 10.000 |
Best ORR was defined as the percentage of patients with complete response (CR) or partial response (PR) based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 65.5 | 58.90 – 71.67 |
| Rituximab + Bendamustine | 61.7 | 55.01 – 68.03 |
Best ORR was defined as the percentage of patients with CR or PR based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 64.8 | 53.86 – 74.66 |
| Rituximab + Bendamustine | 59.5 | 47.41 – 70.73 |
Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 7.40 | 5.800 – 12.100 |
| Rituximab + Bendamustine | 12.10 | 10.000 – 23.300 |
Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 6.70 | 3.700 – 12.700 |
| Rituximab + Bendamustine | 10.30 | 4.900 – 37.500 |
Overall survival was defined as the time (in months) from randomization until death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 14.60 | 11.600 – 23.400 |
| Rituximab + Bendamustine | 20.20 | 13.400 – 24.300 |
Overall survival was defined as the time (in months) from randomization until death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 10.60 | 8.300 – 19.700 |
| Rituximab + Bendamustine | 12.50 | 8.300 – 32.300 |
DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD) based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or progressive disease (PD; any new lesion or an increase by ≥50% of previously involved sites from nadir).
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 76.1 | 70.00 – 81.51 |
| Rituximab + Bendamustine | 71.8 | 65.47 – 77.56 |
DCR was defined as the percentage of participants with a CR, PR, or SD based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or PD (any new lesion or an increase by ≥50% of previously involved sites from nadir).
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 75.0 | 64.63 – 83.62 |
| Rituximab + Bendamustine | 70.3 | 58.52 – 80.34 |
Time to progression was defined as the time (in months) from randomization until documented diffuse large B-call lymphoma (DLBCL) progression or death as a result of lymphoma. Death from other causes than lymphoma was not considered in relation to the TTP evaluation.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 8.20 | 6.200 – 9.300 |
| Rituximab + Bendamustine | 11.10 | 8.100 – 18.300 |
Time to progression was defined as the time (in months) from randomization until documented diffuse large B-call lymphoma (DLBCL) progression or death as a result of lymphoma. Death from other causes than lymphoma was not considered in relation to the TTP evaluation.
| Group | Value | 95% CI |
|---|---|---|
| Tafasitamab + Bendamustine | 8.00 | 5.400 – 9.200 |
| Rituximab + Bendamustine | 10.00 | 3.800 – 39.400 |
Time frame: up to approximately 7.5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tafasitamab + Bendamustine | Rituximab + Bendamustine |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| COVID-19 | Infections and infestations | — | — |
| Pyrexia | General disorders | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Herpes zoster | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Asthenia | General disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Neutropenic sepsis | Infections and infestations | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Syncope | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Reaction | System | Tafasitamab + Bendamustine | Rituximab + Bendamustine |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Weight decreased | Investigations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
Most-reported serious reactions: Pneumonia, COVID-19, Pyrexia, COVID-19 pneumonia, Febrile neutropenia, Influenza, Neutropenia, Sepsis.
Data from ClinicalTrials.gov NCT02763319 adverse events section.
The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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