The National Institute for Health and Care Excellence ( NICE) has recommended the combination of brentuximab vedotin (BV) with cyclophosphamide, doxorubicin, and prednisone (CHP) as a treatment option in treatment-naïve patients with systemic anaplastic large cell lymphoma (sALCL).
The recommendation, which reflects the European Commission marketing authorizationextension, is based on data from the phase III ECHELON-2trial ( NCT01777152 ). This randomized controlled trial, evaluated BV plus CHP vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as first-line treatment in patients with CD30+ peripheral T-cell lymphoma.
Data from the sALCL subgroup demonstrated:
- Better objective response rate, 88% vs71%, for patients in the BV plus CHP arm (95% confidence interval [CI], 81.6─92.3) vspatients in the CHOP arm (95% CI, 62.9─77.8; p = 0.0001), respectively
- Reduced risk of a progression event in the BV plus CHP arm vsCHOP arm (stratified hazard ratio 0.59, 95% CI, 0.42─0.84; p = 0.0031)
- Improved overall survival in the BV plus CHP arm vsCHOP arm (hazard ratio 0.54, 95% CI, 0.337─0.867; p = 0.0096)
The appraisal committee concluded that BV in combination with CHP would replace CHOP for patients with untreated sALCL in the National Health Service (NHS).