Posted: Thursday, July 21, 2022
The monoclonal antibody obinutuzumab plus lenalidomide (often referred to as the GALEN combination) has demonstrated clinical activity and a manageable safety profile in multiple types of lymphoma. Emmanuel Bachy, MD, PhD, of Lyon 1 Claude Bernard University, France, and colleagues conducted the phase II GALEN trial to evaluate the efficacy and safety of this immunomodulatory regimen in previously untreated patients with advanced follicular lymphoma. Their findings were published in the journal Blood.
“Overall, these results showed promising clinical efficacy for the chemotherapy-free GALEN backbone in previously untreated patients with high–tumor burden follicular lymphoma,” the investigators remarked. “Except for neutropenia, the safety profile of the combination is remarkable.”
Between October 2015 and February 2017, a total of 100 patients received induction therapy with intravenous obinutuzumab plus lenalidomide for six cycles. Maintenance therapy consisted of obinutuzumab plus lenalidomide for up to 12 cycles followed by obinutuzumab for 6 cycles.
The complete response rate after induction therapy was 47%, and the overall response rate was 92%. Post hoc analyses per the 2014 Lugano classification, which included patients with missing bone marrow assessments, identified an additional 13 patients fulfilling the criteria for complete response; this resulted in a complete metabolic response rate of 80% and an overall response rate of 94%. The 3-year progression-free and overall survival rates were 82% and 94%, respectively, at a median follow-up of 3.7 years.
Neutropenia was the most frequently reported adverse event (any grade: 48%; grade ≥ 3: 47%). A total of 2% of patients presented with febrile neutropenia. According to the investigators, no other specific toxicity of grade 3 or higher was observed in more than 3% of the population.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.