Table 3.

BTKis combined with venetoclax with or without anti-CD20 monoclonal antibodies in patients with R/R CLL

Trial phaseTreatmentNo. of patientsTP53 aberrationsScheduleStrategyuMRD* rateDiscontinuation rateMedian follow-up
Phase II48  IBRU-VEN 80 30% del(17p) and TP53 mutation IBR for 3c, IBRU+ VEN 4-27c MRD+ in BM could continue ibrutinib 67% uMRD in BM at 24 c 19% 22 mo 
Phase II45  IBRU-VEN 53 22% del(17p) IBRU 1-2c, IBRU+VEN after cycle 2 PB/BM uMRD at cycle 8: cease therapy after cycle 14; PB/BM uMRD between cycles 14 and 26: cease therapy after cycle 26; MRD-positive at cycle 26: continue IBR monotherapy uMRD 53% in PB at 12 mo; uMRD 36% in BM at 12 mo Not reported 21 mo 
Phase II49  IBRU-VEN 51 18% del(17p) and TP53 mutation IBRU 1-2 c, IBR + VEN 3-15 c > PR and BM uMRD after cycle 15 randomized to observation or IBR monotherapy*; MRD recrudescence retreated with combination uMRD 55% in PB; uMRD 39% in BM 16% 15 mo 
Phase II50  IBRU-VEN 24 50% del(17p)/50% TP53 mutation IBR+VEN for up to 2 y uMRD CR on 2 assessments: discontinue all therapy or continue IBR monotherapy*; patients MRD-positive or less than CR: continue IBR monotherapy 67% uMRD in BM at 12 mo (in 15 evaluable patients) 12% NA 
Phase Ib51  IBRU-VEN-OBINU 12 8% del(17p) OBINU 1-8 c + IBRU 2-14 c + VEN 3-14 c After cycle 14, can continue IBR monotherapy 100% uMRD in PB/50% uMRD in BM at 14 c Not reported 24 mo 
Phase II52  IBRU-VEN-OBINU 25 Not reported OBINU 1-8 c + IBRU 2-14 c + VEN 3-14 c After cycle 14, can continue IBR monotherapy 100% uMRD in PB/50% uMRD in BM at 14 c Not reported 18 mo 
Trial phaseTreatmentNo. of patientsTP53 aberrationsScheduleStrategyuMRD* rateDiscontinuation rateMedian follow-up
Phase II48  IBRU-VEN 80 30% del(17p) and TP53 mutation IBR for 3c, IBRU+ VEN 4-27c MRD+ in BM could continue ibrutinib 67% uMRD in BM at 24 c 19% 22 mo 
Phase II45  IBRU-VEN 53 22% del(17p) IBRU 1-2c, IBRU+VEN after cycle 2 PB/BM uMRD at cycle 8: cease therapy after cycle 14; PB/BM uMRD between cycles 14 and 26: cease therapy after cycle 26; MRD-positive at cycle 26: continue IBR monotherapy uMRD 53% in PB at 12 mo; uMRD 36% in BM at 12 mo Not reported 21 mo 
Phase II49  IBRU-VEN 51 18% del(17p) and TP53 mutation IBRU 1-2 c, IBR + VEN 3-15 c > PR and BM uMRD after cycle 15 randomized to observation or IBR monotherapy*; MRD recrudescence retreated with combination uMRD 55% in PB; uMRD 39% in BM 16% 15 mo 
Phase II50  IBRU-VEN 24 50% del(17p)/50% TP53 mutation IBR+VEN for up to 2 y uMRD CR on 2 assessments: discontinue all therapy or continue IBR monotherapy*; patients MRD-positive or less than CR: continue IBR monotherapy 67% uMRD in BM at 12 mo (in 15 evaluable patients) 12% NA 
Phase Ib51  IBRU-VEN-OBINU 12 8% del(17p) OBINU 1-8 c + IBRU 2-14 c + VEN 3-14 c After cycle 14, can continue IBR monotherapy 100% uMRD in PB/50% uMRD in BM at 14 c Not reported 24 mo 
Phase II52  IBRU-VEN-OBINU 25 Not reported OBINU 1-8 c + IBRU 2-14 c + VEN 3-14 c After cycle 14, can continue IBR monotherapy 100% uMRD in PB/50% uMRD in BM at 14 c Not reported 18 mo 

BM, bone marrow; c, cycles; IBR, ibrutinib; IBRU, ibrutinib; NA, not available; OBINU, obinutuzumab; PB, peripheral blood; PR, partial response; VEN, venetoclax.

*

uMRD defined as < 1 CLL cell per 10000 leukocytes.

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