*Undetectable disease is defined by uMRD at the threshold of <1 tumour cell per 104 white cells1-3
†CLL-14 was a Phase III, randomised, multicentre, open-label trial which evaluated VEN+O (n=216) vs Clb+O (n=216) in adult patients with previously untreated CLL (age ≥18 years) and coexisting medical conditions (total CIRS>6 or CrCl<70mL/min). MURANO (N=398) was a phase III, randomised, multicentre, open-label trial of VEN+R vs BR in patients with R/R CLL. The primary endpoint of investigator-assessed PFS was met in both these trials. uMRD was a secondary endpoint in both trials in the ITT population. CLL-14: 75.5% VEN+O (n=163/216) peripheral blood uMRD, 3 months after treatment completion vs 35% Clb+O (n=76/216) p<0.001.2 MURANO: 62% VEN+R (n=121/194) peripheral blood uMRD at 9 months vs BR 13% (n=26/195) ITT population, not tested for significance.3
1L=first line; BR=bendamustine + rituximab; CIRS=cumulative illness rating scale; Clb+O=chlorambucil + obinutuzumab; CLL=chronic lymphocytic leukaemia; CrCL=creatinine clearance; ITT=intent-to-treat; PFS=progression-free survival; R/R=relapsed/refractory; TLS=tumour lysis syndrome; VEN+O=VENCLYXTO + obinutuzumab; VEN+R=VENCLYXTO + rituximab; uMRD=undetectable minimal residual disease.