VENCLEXTA + Obinutuzumab + Bendamustine Effective for Follicular Lymphoma?
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Between December 11 and 13, 2021, Craig A. Portell and colleagues from the University of Virginia presented the effectiveness and safety results of the PrECOG 0403 Phase II clinical trial at the 63rd American Society of Hematology Annual Meeting. The trial evaluated the BCL-2 inhibitor VENCLEXTA + anti-CD20 antibody Obinutuzumab + bendamustine as a first-line treatment for patients with high-tumor-burden follicular lymphoma.
In the PrECOG 0403 Phase II trial, patients with high-tumor-burden follicular lymphoma (N=56) received VENCLEXTA (800mg once daily on days 1–10) + Obinutuzumab (1000mg; for the first cycle: 100mg on day 1, 900mg on day 2, and 1000mg on days 8 and 15) + bendamustine (90mg/m² on days 1 and 2) in 28-day treatment cycles as first-line therapy. The primary endpoint was the complete response rate (CRR).
The median age of patients in the trial was 62 years (range 33–79); 63% were male (N=35) and 38% were female (N=21). Disease stages were: Phase II (4%), Phase III (29%), and Phase IV (68%).
The results were as follows: The primary endpoint, the complete response rate, was 73.2%. With a median follow-up of 20.9 months, the secondary endpoints showed a 2-year overall survival rate of 94.4% and a 2-year progression-free survival rate of 85.8%.
Regarding safety, more than 20% of patients experienced side effects, including: nausea (82.1%), fatigue (60.7%), vomiting (46.4%), diarrhea (42.9%), thrombocytopenia (41.1%), neutropenia (37.5%), headache (28.6%), anorexia (26.8%), and anemia (21.4%). The incidence of Grade 3 or higher side effects was 83.9%, primarily neutropenia (16.1%), tumor lysis syndrome (14.3%), and thrombocytopenia (14.3%).
Based on the results of the PrECOG 0403 trial, Craig A. Portell and colleagues stated that the first-line treatment of high-tumor-burden follicular lymphoma with VENCLEXTA + Obinutuzumab + bendamustine met the benchmark for the primary endpoint of complete response rate. While there is a possibility for improvement in progression-free survival, the incidence of Grade 3 or higher side effects was 83.9%, which requires continued follow-up monitoring.
Source: https://ash.confex.com/ash/2021/webprogram/Paper145217.html
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