Venetoclax

Posted results on ClinicalTrials.gov for VIALE-M

Serious adverse events (All-cause mortality and adverse event tables include events reported from the time of informed consent to the interim cutoff date of 05OCT2022. The median time on follow-up was 446, 687, 389 days for Part 1 VEN400_AZA20, VEN400_AZA36, VEN400_AZA50 and 67.5, 275 days for Part 3 Dose Level 1 (VEN400_CC200), Dose Level 2 (VEN400_CC300), respectively.): Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 5 of 23; Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 7 of 23; Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 5 of 20; Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg 5 of 30; Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg 3 of 16

Source: ClinicalTrials.gov results for NCT04102020 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for VIALE-T

• Overall Survival (OS) (Part 2) (months)
  • Part 2: Best Supportive Care vs Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD: Stratified Hazard Ratio 1.2 (95% CI 0.81 to 1.77), superiority

Serious adverse events (All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 53.2, 60.2, 27.4, and 27.9 months for arms Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD, Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD, Part 2: Best Supportive Care, and Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD, respectively.): Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD 9 of 30; Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD 2 of 5; Part 2: Best Supportive Care 66 of 216; Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD 97 of 214

Source: ClinicalTrials.gov results for NCT04161885 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for NCT03941964

Serious adverse events (All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.): Venetoclax 400 mg + Azacitidine 75 mg 19 of 30; Venetoclax 400 mg + Decitabine 20 mg 22 of 30; Venetoclax 400 mg + Azacitidine 75 mg or Decitabine 20 mg 41 of 60

Source: ClinicalTrials.gov results for NCT03941964 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for NCT03406156

Serious adverse events (All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time patients were followed was: 1183.0 days (Obinutuzumab Debulking); 1185.5 days (Obinutuzumab + Bendamustine Debulking); 1114.0 days (Obinutuzumab + Venetoclax Post-debulking); and 992.5 days (Venetoclax Monotherapy Post-debulking).): Obinutuzumab Debulking 7 of 84; Obinutuzumab + Bendamustine Debulking 3 of 36; Obinutuzumab + Venetoclax Post-debulking 15 of 117; Venetoclax Monotherapy Post-debulking 13 of 114

Source: ClinicalTrials.gov results for NCT03406156 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for NCT03069352

• Overall Survival (OS) (months)
  • Venetoclax + Low Dose Cytarabine (LDAC) vs Placebo + Low Dose Cytarabine (LDAC): Hazard Ratio (HR) 0.749 (95% CI 0.524 to 1.071), p-value 0.114, Log Rank, superiority
  • Venetoclax + Low Dose Cytarabine (LDAC) vs Placebo + Low Dose Cytarabine (LDAC): Hazard Ratio (HR) 0.743 (95% CI 0.521 to 1.061), p-value 0.103, Log Rank, superiority

Serious adverse events (All protocol-related serious adverse events and nonserious adverse events were collected from informed consent until study drug start, up to 21 days. All adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 90.0 months for VEN + LDAC and 33.3 months for PBO + LDAC. Median time on follow-up: VEN + LDAC (8.4 months); PBO + LDAC (4.1 months)): Venetoclax + Low Dose Cytarabine (LDAC) 103 of 143; Placebo + Low Dose Cytarabine (LDAC) 43 of 68

Source: ClinicalTrials.gov results for NCT03069352 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for Viale-a

• Overall Survival (OS) (months)
  • Group 2: Placebo + Azacitidine 75 mg/m^2 vs Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2: Hazard Ratio (HR) 0.580 (95% CI 0.465 to 0.723), p-value <0.001, Log Rank, superiority
• Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) (percentage of participants)
  • Group 2: Placebo + Azacitidine 75 mg/m^2 vs Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2: Estimate not given, p-value <0.001, Cochran-Mantel-Haenszel, superiority

Serious adverse events (From the study start until data cut-off date: 01 December 2021 (up to approximately 4.8 years)): Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 111 of 144; Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 242 of 283; Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 7 of 10

Source: ClinicalTrials.gov results for NCT02993523 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for VENICE II

• 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) (units on a scale)
  • Venetoclax: Estimate not given, p-value =0.004, t-test, 2 sided, superiority

Serious adverse events (All-cause mortality is reported from enrollment to end of study; median time on follow-up was 184 weeks. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 123 weeks.): Venetoclax 106 of 210

Source: ClinicalTrials.gov results for NCT02980731 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for Bellini

• Progression-free Survival (PFS) (months)
  • Venetoclax + Bortezomib and Dexamethasone vs Placebo + Bortezomib and Dexamethasone: Hazard Ratio (HR) 0.656 (95% CI 0.471 to 0.913), p-value =0.012, Log Rank, superiority

Serious adverse events (All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.): Venetoclax + Bortezomib and Dexamethasone 115 of 193; Placebo + Bortezomib and Dexamethasone 53 of 96

Source: ClinicalTrials.gov results for NCT02755597 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Posted results on ClinicalTrials.gov for VENICE I

• Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis (percentage of participants)
  • Venetoclax: Estimate not given, p-value <0.001, Binomial test, superiority

Serious adverse events (All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.): Venetoclax 136 of 258

Source: ClinicalTrials.gov results for NCT02756611 (opens in a new tab)· imported 26 Oct 2026

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.