Abstract
Introduction: Fixed-Duration venetoclax plus obinutuzumab (VenO) has shown efficacy and safety in patients with 1L CLL, establishing it as a recommended standard of care. Recently, phase 3 studies reported improved quality of life (QoL) and sustained benefits post-treatment in these patients. This report presents real-world QoL of 1L CLL patients treated with VenO, providing practical insights beyond controlled clinical trial environments.
Methods: VeRVe is a prospective, non-interventional study in Germany, Austria and Switzerland. Patient-reported outcomes were collected from enrolled patients treated with VenO as per local label via the EORTC QLQ-C30 and -CLL17 questionnaires at baseline, end of ramp-up and after 6, 12, 18 and 24 months (mos). Results are descriptive and were evaluated as per manual. Influence of age and risk factors were analyzed in a linear regression model and by Mann-Whitney-U-tests, respectively.
Results: Until 13-Feb-2025, 101 patients with 1L CLL were enrolled and received at least one dose of VenO. Median age was 62 years (range 37-85); 87% had comorbidities. 24.1% were documented TP53 mut and/or del17p; 64.2% were documented IGHV unmutated. Median follow-up was 24.5 mos (min 0, max 36.2). Available PRO data decreased over time (n=68 at BL, and 55, 45, 34, 30, 28 at end of ramp-up, after 6, 12, 18, 24 mos). From BL until end of ramp-up, the global health status (GHS)/QoL increased 7.8 points (mean 59.8 at BL vs 67.6 after ramp-up). After 12 mos, the GHS/QoL remained stable and improved by 10.3 points during time off treatment (70.1 after 24 mos (59.8. at BL, 70.1 after 24 mos, p=0.049). Age, comorbidities, TP53 aberrations and IGHV status did not influence QoL.
Symptom burden (25 at BL, 21.9 after ramp-up, 15.2 after 24 mos), physical condition/fatigue (36.8 at BL, 32.4 after ramp-up, 25.3 after 24 mos), worries/fear of health (41.1 at BL, 33.8 after ramp-up, 35.6 after 24 mos) and functioning decreased over time and remained stable after end of treatment.
Conclusions: Durable improvements in QoL and symptom burden were observed shortly after treatment initiation and continued to improve beyond end of treatment. Age, comorbidities and TP53 and IGHV status did not influence QoL. Together with previously reported clinical outcomes, these results support the value of fixed-duration VenO for patients with 1L CLL in the real-world and complement recent QoL reports from the phase 3 GAIA/CLL13 and CLL14 studies.
Additional Disclosures: AbbVie sponsored this study and contributed to the design, study conduct. AbbVie participated in the interpretation of data, review, and approval of the publication. All authors had access to all relevant data. Statistical support was provided by GermanOncology GmbH, which was funded by AbbVie.
