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Lenalidomide/Rituximab Data Published as FDA Weighs Non-Hodgkin Lymphoma Approval

Jason M. Broderick @jasoncology
Published: Tuesday, Apr 09, 2019

John P. Leonard, MD

John P. Leonard, MD

The R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) significantly reduced the risk of disease progression or death compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma, according to results from the pivotal phase III AUGMENT trial, now published in the Journal of Clinical Oncology.

The study findings showed that at a median follow-up of 28.3 months, the median progression-free survival (PFS) per independent review was 39.4 months (95% CI, 22.9–not evaluable) with R2 versus 14.1 months (95% CI, 11.4-16.7) with rituximab alone, translating to a 54% reduction in the risk of disease progression or death (HR, 0.46; 95% CI, 0.34-0.62; P <.001).

By investigator assessment, the median PFS was 25.3 months (95% CI, 21.2–not evaluable) versus 14.3 months (95% CI, 12.4-17.7), respectively (HR, 0.51; 95% CI, 0.38-0.69; P <.001). Overall response rate (ORR) was also significantly improved with the combination. The ORR per independent review was 78% with R2 versus 53% with rituximab alone (P <.001). The 78% ORR rate in the R2 arm comprised a 34% complete response rate and a 44% partial response rate.

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