Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02005471 MURANO | Leukemia, Lymphocytic, Chronic, B-Cell | Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months) | Bendamustine + Rituximab Main Study | 88.7 percentage of participants |
| Venetoclax + Rituximab Main Study | 70.1 percentage of participants | |||
| NCT02005471 MURANO | Leukemia, Lymphocytic, Chronic, B-Cell | Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months) | Bendamustine + Rituximab Main Study | 17.0 months |
| Venetoclax + Rituximab Main Study | 54.7 months | |||
| NCT02242942 | Leukemia, Lymphocytic, Chronic, B-Cell | Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria Baseline until disease progression or death up to approximately 3.75 years | Obinutuzumab + Chlorambucil | NA months |
| Obinutuzumab + Venetoclax | NA months | |||
| NCT02755597 Bellini | Multiple Myeloma | Progression-free Survival (PFS) Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group | Placebo + Bortezomib and Dexamethasone | 11.5 months |
| Venetoclax + Bortezomib and Dexamethasone | 23.2 months | |||
| NCT02756611 VENICE I | Leukemia, Lymphocytic, Chronic, B-Cell | Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. | Venetoclax | 35.1 percentage of participants |
| NCT02980731 VENICE II | Leukemia, Lymphocytic, Chronic, B-Cell | Mean Change From Baseline to Week 48 in Global Health Status/Quality of Life (GHS/QoL) Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Baseline, Week 48 | Venetoclax | 9.3 units on a scale (±20.11 Standard Deviation) |
| NCT02993523 Viale-a | Leukemia, Myeloid, Acute | Overall Survival (OS) From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021) | Group 2: Placebo + Azacitidine 75 mg/m^2 | 9.6 months |
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 14.7 months | |||
| NCT02993523 Viale-a | Leukemia, Myeloid, Acute | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021) | Group 2: Placebo + Azacitidine 75 mg/m^2 | 17.9 percentage of participants |
| Group 2: Placebo + Azacitidine 75 mg/m^2 | 11.0 percentage of participants | |||
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 28.0 percentage of participants | |||
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 38.8 percentage of participants | |||
| Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 20.0 percentage of participants | |||
| Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 60.0 percentage of participants | |||
| NCT03069352 | Leukemia, Myeloid, Acute | Overall Survival (OS) From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. | Placebo + Low Dose Cytarabine (LDAC) | 4.1 months |
| Venetoclax + Low Dose Cytarabine (LDAC) | 7.2 months | |||
| NCT03112174 SYMPATICO | Lymphoma, Non-Hodgkin | Complete Response (CR) Rate (Treatment-Naive Arm) For an overall median time on study of 40.51 months | Treatment-naive Open-label Arm | 69.2 percentage of participants |
| NCT03112174 SYMPATICO | Lymphoma, Non-Hodgkin | Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) After at least 3 months of treatment, with an overall median treatment duration of 20.0 months | Safety Run-in: Increased TLS Risk at Baseline | 1 Participants |
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| NCT03112174 SYMPATICO | Lymphoma, Non-Hodgkin | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in) From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 months | Safety Run-in: Increased TLS Risk at Baseline | 10 Participants |
| Safety Run-in: Increased TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 10 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 15 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 15 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 14 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 13 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 13 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 12 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 6 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 4 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 7 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 14 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 13 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 14 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 14 Participants | |||
| Safety Run-in: Increased TLS Risk at Baseline | 9 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 5 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 4 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 4 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 2 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 6 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 4 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 1 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 4 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 6 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 3 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 5 Participants | |||
| Safety Run-in: Low TLS Risk at Baseline | 3 Participants | |||
| NCT03112174 SYMPATICO | Lymphoma, Non-Hodgkin | Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) After at least 3 months of treatment, with an overall median treatment duration of 20.0 months | Safety Run-in: Increased TLS Risk at Baseline | 1 Participants |
| Safety Run-in: Low TLS Risk at Baseline | 0 Participants | |||
| NCT03112174 SYMPATICO | Lymphoma, Non-Hodgkin | Progression-free Survival (PFS) (Randomization Phase) For an overall median time on study of 61.34 months | Randomization Phase: Ibrutinb + Venetoclax | 31.9 months |
| Randomization Phase: Ibrutinib + Placebo | 22.1 months | |||
| NCT03336333 SEQUOIA | Leukemia, Lymphocytic, Chronic, B-Cell | Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 33.7 Months |
| Cohort 1: Zanubrutinib Without Del(17p) | NA Months | |||
| NCT03406156 | Leukemia, Lymphocytic, Chronic, B-Cell | Complete Remission Rate From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days | Obinutuzumab | 51.2 percentage of participants |
| Obinutuzumab/Bendamustine | 16.7 percentage of participants | |||
| NCT03406156 | Leukemia, Lymphocytic, Chronic, B-Cell | Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug | Obinutuzumab | 81.4 percentage of participants |
| Obinutuzumab | 95.0 percentage of participants | |||
| Obinutuzumab | 88.3 percentage of participants | |||
| Obinutuzumab/Bendamustine | 83.9 percentage of participants | |||
| Obinutuzumab/Bendamustine | 90.3 percentage of participants | |||
| Obinutuzumab/Bendamustine | 87.1 percentage of participants | |||
| NCT03462719 GLOW | Leukemia, Lymphocytic, Chronic, B-Cell | Progression Free Survival (PFS) Up to 2 years 10 months | Treatment Arm A (Ibrutinib + Venetoclax) | NA Months |
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 20.96 Months | |||
| NCT03737981 | Leukemia, Lymphocytic, Chronic, B-Cell | Progression-free Survival (PFS) 5 years | Arm I (Ibrutinib, Obinutuzumab) | 0.59 proportion of participants w/out event |
| Arm II (Ibrutinib, Obinutuzumab, Venetoclax) | 0.68 proportion of participants w/out event | |||
| NCT03801525 ULTRA-V | Leukemia, Lymphocytic, Chronic, B-Cell | Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria Up to 43.2 months | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 33.6 percentage of participants |
| NCT03801525 ULTRA-V | Leukemia, Lymphocytic, Chronic, B-Cell | Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria Up to 43.2 months | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 93.3 percentage of participants |
| NCT03801525 ULTRA-V | Leukemia, Lymphocytic, Chronic, B-Cell | Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria Up to 43.2 months | Phase 3: Ublituximab + Umbralisib (U2) | NA months |
| Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | NA months | |||
| NCT03941964 | Leukemia, Myeloid, Acute | Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. | Venetoclax 400 mg + Azacitidine 75 mg | 70.0 percentage of participants |
| Venetoclax 400 mg + Decitabine 20 mg | 63.3 percentage of participants | |||
| NCT04102020 VIALE-M | Leukemia, Myeloid, Acute | Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion) Up to 28 days (Cycle 1) | Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 0 Participants |
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 1 Participants | |||
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 0 Participants | |||
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 1 Participants | |||
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 1 Participants | |||
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 0 Participants | |||
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 1 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 1 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 2 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 1 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 1 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 1 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 0 Participants | |||
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 1 Participants | |||
| NCT04102020 VIALE-M | Leukemia, Myeloid, Acute | Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) Up to 28 days (Cycle 1) | Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | 1 Participants |
| Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | 1 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | 1 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | 3 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | 4 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | 0 Participants | |||
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | 4 Participants | |||
| NCT04285567 CRISTALLO | Leukemia, Lymphocytic, Chronic, B-Cell | Minimal Residual Disease (MRD) Response Rate Measured in Peripheral Blood (PB) Using Next Generation Sequencing (NGS) At Month 15 | Arm A: VEN+G | 81.3 percentage of participants |
| Arm B: FCR/BR | 54.7 percentage of participants | |||
| NCT04778397 ENHANCE-2 | Leukemia, Myeloid, Acute | Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy Up to 2.1 years | Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) | 6.6 months |
| Magrolimab + Azacitidine (Non-Intensive Therapy) | 4.4 months | |||
| NCT05079230 ENHANCE-3 | Leukemia, Myeloid, Acute | Overall Survival (OS) Up to 1.6 years | Magrolimab + Venetoclax + Azacitidine | 10.7 months |
| Magrolimab Matching Placebo + Venetoclax + Azacitidine | 14.1 months |