phase 3b venice 1 (m15-550): study design and endpoints · 2021. 3. 12. · • cr rate in bcri...

Venetoclax is being codeveloped by AbbVie and Genentech, a member of the Roche Group. To learn more about these studies, please visit https://ClinicalTrials.gov or email [email protected] Key Inclusion Criteria • Relapsed/refractory CLL patients including those with the 17p deletion or TP53 mutation, or those who have received prior B-cell receptor therapy • Adequate bone marrow function: platelets ≥ 25,000/mm 3 (without transfusion support within 2 weeks of screening); hemoglobin ≥ 8.0 g/dL • Adequate renal function (calculated CrCl >50 mL/min) • No transformed disease i.e. Richter’s Transformation or Prolymphocytic leukemia (PLL), no prior allogeneic transplant, no active or uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura Phase 3b VENICE 1 (M15-550): Study Design and Endpoints 1 A study to evaluate the efficacy of venetoclax in relapsed/refractory participants with Chronic Lymphocytic Leukemia (CLL) Endpoints Primary Complete Remission Rate (CR + CRi) as assessed by the investigator Secondary • Overall Response Rate (ORR) • Duration of Overall Response (DoR) • Time to Progression (P) • Progression-Free Survival (PFS) • Overall Survival (OS) • CR Rate in BCRi treated subjects • Level of Minimal Residual Disease (MRD) Treatment and Follow-up Periods Treatment Period Venetoclax administered orally once daily with meal and water. Subjects will titrate to 400mg and may continue to receive venetoclax up to 2 years. Follow-up Period Aﬅer treatment discontinuation, subjects will be followed for disease progression and survival. Post-treatment calls will be performed every 6 months for 2 years. Venetoclax is being investigated for indications that have not been approved by Regulatory Agencies. Safety and Efficacy have not been established in unapproved indications. 1. https://clinicaltrials.gov/ct2/show/NCT02756611 (accessed May 2017) Venetoclax single agent Week 1 * Week 2 * Week 3 * Week 4 * Relapsed / Refractory CLL (N = 250) 20 mg QD 50 mg QD 100 mg QD 200 mg QD 400 mg QD venetoclax (400mg) daily for 2 years or until unacceptable toxicity or progression * Dose titration will occur in accordance with specific risk-based TLS prophylaxis and monitoring measures that may include dose delay and/or reduction. Week 5 onwards * ©2017 AbbVie Inc. North Chicago, IL 60064 A14543624 Aug 2017 Printed in U.S.A.

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Page 1: Phase 3b VENICE 1 (M15-550): Study Design and Endpoints · 2021. 3. 12. · • CR Rate in BCRi treated subjects • Level of Minimal Residual Disease (MRD) Treatment and Follow-up

Venetoclax is being codeveloped by AbbVie and Genentech, a member of the Roche Group.

To learn more about these studies, please visit https://ClinicalTrials.gov or email [email protected]

Key Inclusion Criteria• Relapsed/refractory CLL patients including those with the

17p deletion or TP53 mutation, or those who have received prior B-cell receptor therapy

• Adequate bone marrow function: platelets ≥ 25,000/mm3 (without transfusion support within 2 weeks of screening); hemoglobin ≥ 8.0 g/dL

• Adequate renal function (calculated CrCl >50 mL/min)

• No transformed disease i.e. Richter’s Transformation or Prolymphocytic leukemia (PLL), no prior allogeneic transplant, no active or uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura

Phase 3b VENICE 1 (M15-550): Study Design and Endpoints 1

A study to evaluate the efficacy of venetoclax in relapsed/refractory participants with Chronic Lymphocytic Leukemia (CLL)

Endpoints

PrimaryComplete Remission Rate (CR + CRi) as assessed by the investigator

Secondary• Overall Response Rate (ORR)• Duration of Overall Response (DoR)• Time to Progression (TTP)• Progression-Free Survival (PFS)• Overall Survival (OS)• CR Rate in BCRi treated subjects• Level of Minimal Residual Disease (MRD)

Treatment and Follow-up PeriodsTreatment PeriodVenetoclax administered orally once daily with meal and water.Subjects will titrate to 400mg and may continue to receive venetoclax up to 2 years.

Follow-up PeriodAfter treatment discontinuation, subjects will be followed for disease progression and survival. Post-treatment calls will be performed every 6 months for 2 years.

Venetoclax is being investigated for indications that have not been approved by Regulatory Agencies. Safety and Efficacy have not been established in unapproved indications. 1. https://clinicaltrials.gov/ct2/show/NCT02756611 (accessed May 2017)

Venetoclaxsingle agent

Week 1*Week 2*

Week 3*Week 4*

Relapsed / Refractory CLL

(N = 250)

20 mg QD

50 mg QD

100 mg QD

200 mg QD

400 mg QD

venetoclax (400mg)daily for 2 years or until unacceptable toxicity or progression

* Dose titration will occur in accordance with specific risk-based TLS prophylaxis and monitoring measures that may include dose delay and/or reduction.

Week 5onwards*

M15 HD and Audyssey

Travelling m15

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M15 Urinary System - Weebly

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CALIFORNIA STATE BOARD OF EQUALIZATION SUMMARY …reliance on BCRI Valuation Services (BCRI) percent-good factors. FINDINGS OF FACT AND RELATED CONTENTIONS Verizon California, Inc

MRD Protocol

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MRD Final Presentation

PXG-M15 Evaluation DataPXG-M15-24D15 P11 PXG-M15-48WD12 P27 Input Start-Up and Output Rise PXG-M15-48D05 P13 PXG-M15-48WD15 P29 Transient Response PXG-M15-48D12 P15 On/Off Voltage