Dr Fürstenau on Safety Data From the GAIA/CLL13 Trial in Untreated CLL

Moritz Fürstenau, MD, Division of Haematology, Immunology, Infectiology, Intensive Care, and Oncology, University of Cologne, discusses the safety profile of venetoclax (Venclexta) plus obinutuzumab (Gazyva) with or without ibrutinib (Imbruvica) vs chemotherapy in fit patients with previously untreated chronic lymphocytic leukemia (CLL), according to data from the phase 3 GAIA/CLL13 trial (NCT02950051).

The toxicities observed with both the doublet and triplet regimens in this trial were consistent with previous data, Fürstenau begins. Among patients treated with the venetoclax plus obinutuzumab doublet, hematological toxicities including neutropenia and low platelet counts were observed, he reports. Infections, including upper respiratory tract infections and pneumonia, were also reported. These AEs were within the anticipated range for this combination and did not exceed what is typically expected, Fürstenau notes. However, the addition of ibrutinib to this regimen introduced more ibrutinib-associated toxicities. The triplet therapy group experienced a higher incidence of cardiac AEs, infectious complications including atypical and invasive fungal infections, and increased bruising, which aligns with the known class effects of BTK inhibitors, Fürstenau explains.

It is important to note that the GAIA trial included younger, fit patients with fewer comorbidities, which may not reflect the real-world CLL population, he emphasizes. In older or more frail patients, the safety profile might differ, necessitating greater attention to potential drug interactions and prior health conditions, Fürstenau adds.

When considering the application of these findings to a broader patient population, it is crucial to pay close attention to potential interactions between the treatment regimen and other medications the patient may be taking, he continues. Although results from the GAIA trial are reassuring for a fit patient population, they underscore the need for careful monitoring and management of toxicities in more vulnerable patients, he says. Clinicians must remain vigilant in managing these therapies, particularly in a real-world setting where patient profiles can be significantly more varied and complex than those seen in clinical trials, Fürstenau concludes.