Newly Approved Gazyva May Become Standard in Older, Sicker Patients with Chronic Lymphocytic Leukemia

In previous studies of chronic lymphocytic leukemia (CLL), patients who were relatively healthy were often enrolled over older, sicker patients, despite the fact that the majority of patients with CLL are more than 65 years old and often have other health issues (comorbidities). The CLL11 trial was designed to test newer agents in an older population that better reflects reality.

The study included 781 participants with newly diagnosed CLL, a median age of 73 and comorbidities, such as cardiovascular problems, pulmonary disease and diabetes. These patients usually can’t tolerate aggressive chemotherapy, so the CLL11 study compared Leukeran (chlorambucil), an older chemotherapy, against Leukeran with Rituxan (rituximab), a current standard of care, or Leukeran with Gazyva (obinutuzumab), a recently approved therapy for newly diagnosed CLL. Results released this past summer found both combination regimens of Leukeran with the newer agents achieved better responses over Leukeran alone.

Updated results announced at the ASH conference found Gazyva significantly delayed progression-free survival over Rituxan (26.7 months versus 15.2 months). Adding Gazyva also tripled complete responses compared with Rituxan (21 percent versus 7 percent). The most common side effects included low white blood cell counts (neutropenia), infusion-related reactions and low blood platelet counts (thrombocytopenia).

“If we look to the head-to-head comparison, the overall survival data are still immature, however [the data] look quite promising,” says lead investigator Valentin Goede, a clinical scientist at the University Hospital of Cologne in Germany. As a result of these findings, it’s predicted Gazyva may become a standard first-line treatment for elderly patients with comorbidities.