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CCTG LY.16 study findings presented at ASCO

The abstract for the RELEVANCE/LY.16 study was presented at ASCO on June 3rd, 2018. This study compared the effects of lenalidomide plus rituximab (R2) to chemotherapy plus rituximab (R-chemo) followed by rituximab maintenance in patients with previously untreated follicular lymphoma. The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response (CR/CRu) at 120 weeks and progression-free survival (PFS) during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS).

There was a difference in the safety findings between arms. R-chemo had higher grade 3/4 labs (50% vs 34%) and febrile neutropenia (6% vs 2%).  R2 had higher grade 3/4 cutaneous events (7% vs 1%). Secondary primary malignancies occurred in 7% of the R2 patients and in 9% of R-chemo patients. There was no difference between arms in the frequency of grade 5 AEs (1%). The number of patients that completed treatment in the R2 arm was 69% and 71% R-chemo.

This study had different toxicity profiles and showed no difference in efficacy between the two arms. The president of the Lymphoma Study Association (LYSA), Prof. Gilles Salles, said of the study, “This is the first Phase III trial to evaluate a chemotherapy-free regimen to the established standard of care in patients with previously untreated follicular lymphoma and represents a landmark study in this disease setting.”

Nathan Fowler | ASCO 18 | Key findings of the phase III RELEVANCE trial