Chemotherapy-free regimen in first line treatment of FL
For patients with advanced-stage, previously untreated follicular lymphoma (FL) the current standard of care is rituximab plus chemotherapy (R-chemo) followed by rituximab (R) maintenance. Three-year PFS is approximately 75%, but repeated relapses frequently occur. Combination of the immunomodulatory agent lenalidomide and rituximab (R2) showed promising efficacy in phase II clinical studies. The randomized phase III study RELEVANCE compared R2 to R-chemo, both followed by R maintenance, in previously untreated, advanced FL patients (n=1030). During the Presidential symposium Dr Frank Morschhauser (Centre Hospitalier Universitaire Régional de Lille, France) presented the first results of this study.
The study did not establish superiority of R2 over R-chemo for either of the co-primary endpoints. The rates of complete response (CR)/CR unconfirmed (CRu) at 120 weeks were similar in the R2 vs R-chemo arms (48% vs 53%, p=0.13 per central review), as were the 3-year PFS rates (77% vs 78% per central review). The OS data are still immature, but so far the investigators did not observe any difference (3-year OS 94% in both arms).
Treatment-emergent adverse events were as expected. “What stands out is the higher incidence of neutropenia and febrile neutropenia in the R-chemo arm, and of skin toxicities, especially rash, in the R2 arm”, said Morschhauser. The incidence of second malignancies was similar for both arms.
“These results show that R2, a novel immunomodulatory approach, is a potential first-line option for patients with FL requiring treatment”, he concluded.