Follicular Lymphoma: Triple-Agent Combination Therapy Phase II Results

PrECOG 0403 Phase II Trial Results

• January 5, 2022

On December 11-13, 2021, researchers from University of Virginia led by Craig A. Portell presented PrECOG 0403 Phase II trial results at the 63rd American Society of Hematology Annual Meeting, evaluating venetoclax plus obinutuzumab plus bendamustine as first-line therapy in high-tumor-burden follicular lymphoma.

Trial Design

Patient Population: High-tumor-burden follicular lymphoma (n=56)

Treatment (28-day cycles):

• Venetoclax 800 mg daily (Days 1-10)
• Obinutuzumab 1000 mg daily (Day 1: 100 mg, Day 2: 900 mg, Days 8,15: 1000 mg)
• Bendamustine 90 mg/m² (Days 1-2)

Primary Endpoint: Complete response rate

Patient Demographics

Median age: 62 years (range 33-79)

• Male: 63% (n=35)
• Female: 38% (n=21)
• Stage II: 4%, Stage III: 29%, Stage IV: 68%

Key Efficacy Results

Complete Response Rate: 73.2%

Two-Year Outcomes (median follow-up 20.9 months):

• Overall survival: 94.4%
• Progression-free survival: 85.8%

Safety Profile

Adverse Events (≥20% incidence):

• Nausea: 82.1%
• Fatigue: 60.7%
• Vomiting: 46.4%
• Diarrhea: 42.9%
• Thrombocytopenia: 41.1%
• Neutropenia: 37.5%
• Headache: 28.6%
• Anorexia: 26.8%
• Anemia: 21.4%

Grade 3-4 Toxicities: 83.9%

• Neutropenia: 16.1%
• Tumor lysis syndrome: 14.3%
• Thrombocytopenia: 14.3%

Clinical Conclusions

Venetoclax plus obinutuzumab plus bendamustine achieves high complete response rates in high-tumor-burden follicular lymphoma with improved progression-free survival, though Grade 3-4 toxicity rate (83.9%) requires continued safety monitoring.

Data Source

American Society of Hematology Annual Meeting 2021, Paper 145217

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