Most Patients With Relapsed/Refractory CLL Respond to Obinutuzumab Combination Therapy

More than three-quarters of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) responded to treatment with obinutuzumab plus bendamustine, according to study results published in Leukemia & Lymphoma.

In the phase 2, single-arm study GABRIELL, 72 patients with active relapsed/refractory CLL received combination obinutuzumab plus bendamustine treatment for up to six cycles of 28 days each.

The overall response rate among patients was 78.6%, according to the study. The median progression-free survival was 26 months. Median overall survival was not reached at the end of the 36-month follow-up. Undetectable measurable residual disease was associated with significantly longer progression-free and overall survival.

“TP53 disruption was the only independent predictive factor for response (hazard ratio [HR]: 0.228),” wrote corresponding author José A. Garcia-Marco, MD, PhD, of the Hospital Universitario Puerta de Hierro in Madrid, Spain, and study coauthors. “Unmutated immunoglobulin heavy chain variable region (HR: 16.061) was a negative prognostic factor for progression-free survival.”

Neutropenia (58.3%), thrombocytopenia (26.4%) and febrile neutropenia (11.1%) were common grade 3 or higher adverse events, the study found.

“In conclusion, the combination of obinutuzumab plus bendamustine is an active and generally adequately-tolerated treatment for relapsed/refractory CLL,” the authors advised.

Reference:
Bravo J, Baltasar Tello P, et al. Obinutuzumab plus bendamustine for relapsed/refractory chronic lymphocytic leukemia and predictive and prognostic impact of genetic alterations: the phase II GABRIELL study. Leuk Lymphoma. Published online May 31, 2023. doi:10.1080/10428194.2023.2216327