Roche’s Columvi passes Phase 3 lymphoma test as competition with AbbVie, Genmab continues

Roche’s Columvi is on the path to a full ap­proval and po­ten­tial­ly a la­bel ex­pan­sion in an ear­li­er lym­phoma set­ting af­ter hit­ting the pri­ma­ry end­point of a late-stage tri­al.

The CD20xCD3 bis­pe­cif­ic an­ti­body al­ready won FDA ac­cel­er­at­ed ap­proval for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) af­ter two or more lines of ther­a­py in June 2023.

The con­fir­ma­to­ry Phase 3 STAR­G­LO study com­pared Columvi plus gem­c­itabine and ox­ali­platin (GemOx) ver­sus rit­ux­imab plus GemOx in DL­B­CL pa­tients who have had at least one pri­or line of ther­a­py and are not el­i­gi­ble for au­tol­o­gous stem cell trans­plant. Columvi met the tri­al’s pri­ma­ry end­point, achiev­ing a “sta­tis­ti­cal­ly sig­nif­i­cant” im­prove­ment in over­all sur­vival ver­sus con­trol, per a Mon­day re­lease, al­though de­tails were lim­it­ed.

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