Venetoclax and obinutuzumab in first-line treatment of unfit patients with CLL – real-life data analysis of the Polish Adult leukemia group

This is a retrospective analysis of 220 patients with chronic lymphocytic leukemia (CLL) and comorbid conditions defined as a presence of cumulative illness rating scale (CIRS) >6 and/or creatinine clearance <70 ml/min/m2, treated with first-line venetoclax combined with obinutuzumab (Ven-Obi) in the real-world setting. The overall response rate of evaluable patients was 97.4% including 32.7% of complete remissions. The 24-month progression-free survival was 88.4% (95% CI: 83.9-93.2), and 24-month overall survival was 92.7% (95% CI: 89.2-96.4). None of the analyzed factors, including TP53 aberrations or CIRS index >6 impacted the probability of response or patients' survival. The most common adverse events were hematologic toxicity and infections, which frequently led to Ven-Obi dose reduction or withdrawal. Importantly, patients who prematurely discontinued Ven-Obi had poorer outcomes. The combination of Ven-Obi in CLL has proven to be an effective and generally well-tolerated first-line therapy for patients with significant comorbidities in real-world conditions.