Venetoclax has once again demonstrated its clinical potential as a powerful monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), based on new results from the global phase 3b VENICE-1 trial (NCT02756611).
The study evaluated Venetoclax in 258 patients with R/R CLL, both with and without prior exposure to B-cell receptor-associated kinase inhibitors (BCRis). Notably, Venetoclaxmonotherapy achieved deep and durable responses across both patient subgroups, confirming its role as a strong treatment option regardless of BCRi treatment history.
In BCRi-naive patients, 35% achieved a complete remission (CR) or CR with incomplete marrow recovery, while 27% of BCRi-pretreated patients achieved similar remission rates after a median follow-up of over 49 months. At week 48, the overall CR or CRi rate stood at 33%, and the overall response rate (ORR) reached 64% in the BCRi-pretreated group — underscoring the robust efficacy of Venetoclax as a single agent.
Safety outcomes were consistent with the known profile of Venetoclax. Grade 3 or higher treatment-emergent adverse events occurred in 79% of patients, with neutropenia (37%) as the most common. Serious adverse events were reported in 53% of patients, most commonly pneumonia (8%). Thirteen treatment-related deaths were recorded, including one linked to autoimmune hemolytic anemia potentially associated with Venetoclax.
Patient demographics reflected typical CLL profiles, with a median age of 68 and a predominance of male (70%) and White (98%) participants. The majority had received a median of two prior therapies, and among the BCRi-pretreated group, most had been treated with Ibrutinib, Idelalisib, or both.
Since its initial FDA approval in 2016 for CLL with 17p deletion, Venetoclaxhas seen expanded approvals in combination regimens with Rituximab and Obinutuzumab. Yet, these new findings reinforce the efficacy of Venetoclax as a standalone option, offering a valuable treatment path for patients with limited alternatives.
Earlier real-world data from Spain further support these results, showing an ORR of 79.2% with Venetoclaxmonotherapy at 9 months, and up to 92.3% when used in combination with Rituximab.
With its strong performance in both controlled trials and real-world settings, Venetoclaxcontinues to shape the evolving landscape of CLL management — offering hope for deeper remissions and improved quality of life in patients with relapsed or refractory disease.
Reference: https://www.targetedonc.com/view/venetoclax-monotherapy-shows-deep-durable-responses-in-r-r-cll
