Dr. Al-Sawaf on Efforts Examining Venetoclax/Obinutuzumab in CLL

Othman Al-Sawaf, MD, a physician with the University Hospital of Cologne in Germany, discusses research efforts that are evaluating the use of venetoclax (Venclexta) and obinutuzumab (Gazyva) in patients with chronic lymphocytic leukemia (CLL).

The phase 3 CLL14 trial (NCT02242942) evaluated venetoclax plus obinutuzumab compared with chlorambucil and obinutuzumab in previously untreated patients with chronic lymphocytic leukemia (CLL). One of the pitfalls of the trial was that it mainly focused on patients who had coexisting conditions, and the regimen used in the comparator arm is not normally administered to patients who are young and fit, according to Al-Sawaf.

Although the combination was approved by the FDA in May 2019 for the frontline treatment of patients with CLL or small lymphocytic lymphoma, including those who are fit, the question of whether the doublet is comparable to, or superior to, regimens such as fludarabine, cyclophosphamide, and rituximab (FCR; Rituxan) or bortezomib (Velcade) and rituximab (BR), remains open.

It is expected that the combination will demonstrate superiority based on the minimal residual disease negativity rates reported in the CLL14 study, with even better remissions achieved in young and fit patients, Al-Sawaf says. However, randomized comparisons are needed to confirm this, according to Al-Sawaf. 

To this end, the CLL13 study (NCT02950051) will compare venetoclax/obinutuzumab with FCR and BR. The hope is that this trial will provide further data to support the feasibility of this combination in younger, fit patients with CLL, concludes Al-Sawaf.