2L+ CLL: VENCLYXTO® + rituximab
MURANO evaluated VENCLYXTO® + rituximab vs bendamustine + rituximab
*MURANO was a multicenter, open‑label, phase 3 trial. Treatment complete after 5‑week dose‑titration period and twenty‑four 28‑day cycles.
†VENCLYXTO® 400 mg daily after initial dose‑titration period in the absence of disease progression or unacceptable toxicity.
‡Rituximab dosing: 375 mg/m2 IV Day 1, Cycle 1; 500 mg/m2 IV Cycles 2–6. Each cycle was 28 days.
§Bendamustine dosing: 70 mg/m2 IV Days 1 and 2, Cycles 1–6. Each cycle was 28 days.
||Starting Cycle 1, Day 1 of rituximab.
Click here for the full dosing information.
Select inclusion criteria3
- Previously treated with at least 1 prior therapy (including at least 1 chemotherapy-containing regimen)
- Patients treated with prior bendamustine, provided the duration of response was ≥2 years
Primary endpoint1,3
INV-assessed PFS¶
Select secondary endpoints1,3
IRC-assessed PFS
INV- and IRC-assessed ORR, CR, CRi, nPR, and PR (ORR=CR+CRi+nPR+PR)
Overall survival
MRD negativity rates at end of combination treatment#
¶Assessed using the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated National Cancer Institute–sponsored Working Group (NCI-WG) guidelines (2008).1
#MRD was evaluated in the peripheral blood and/or bone marrow using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry. The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes.1
CLL=chronic lymphocytic leukaemia; 1L=first line; 2L+=second line + later lines of therapy; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO® + rituximab; CIT=chemoimmunotherapy; IV=intravenous; INV=investigator; IRC=independent review committee; ORR=overall response rate; CR=complete remission; CRi=complete remission with incomplete marrow recovery; nPR=nodular partial remission; PR=partial response; MRD=minimal residual disease.
Patients completed VENCLYXTO® + rituximab in ~2 years in the MURANO trial1*
VENCLYXTO® + rituximab induced deep responses *, 1,4
VEN + R arm: Clinically meaningful rate of complete remission at 9 months†
*Deep response as indicated by CR or MRD negativity.
†Complete responses were confirmed by computed tomography and by bone marrow histologic analysis. Results are descriptive; statistical significance not tested.
‡MRD results are descriptive; statistical significance not tested. MRD was evaluated in the peripheral blood and/or bone marrow using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry. The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes (secondary endpoint)1
VEN+R=VENCLYXTO®+rituximab; BR=bendamustine + rituximab; CR=complete response; Cri=complete response with incomplete marrow recovery; INV=Investigator; nPR=nodular partial response; ORR-overall response rate; PR=partial response; MRD=minimal residual disease.
The PFS benefit of VENCLYXTO® + rituximab vs BR was sustained at 5‑year follow‑up2
Use VENCLYXTO in your patients with R/R CLL for multiple benefits1,2
*Results are descriptive; not tested for statistical significance
VEN+R = VENCLXTO®+rituximab; BR=bendamustine + rituximab; ITT=intent to treat; HR=hazard ratio; CI=confidence interval; R/R=relapsed/refractory; EoCT=end of combination treatment; EoT=end of treatment
VENCLYXTO® + rituximab PFS benefit was consistent across specific subgroup1*
Data cutoff: 8 May 2017.
*The INV-assessed PFS subgroup analysis was not powered to show statistical significance in subpopulations.
†Unstratified hazard ratio is displayed on the x-axis with logarithmic scale. The size of each square is proportional to the amount of data available.
‡Defined as number of prior lines of therapy.
TP53=tumour protein 53; IgVH=immunoglobulin heavy‑chain variable gene.
Overall survival (OS): VENCLYXTO® + rituximab reduced the risk of death compared with BR2
5 year median follow up
- Estimated OS rates* 82% VEN+R vs 62% BR (HR=0.40; 95% CI: 0.26-0.62)
- 81% (99/123) BR received a novel targeted anti-CLL agent† after disease progression
- 78% (52/67) VEN+R received a novel targeted anti-CLL agent‡ after disease progression
Continued PFS and OS benefit observed over time supports using VENCLYXTO®-based fixed treatment duration regimens 2
*Descriptive endpoint not tested for statistical significance
†Bruton's tyrosine kinase inhibitors [n=60], PI3K inhibitors [n=9], VENCLYXTO [n=10], or investigational medicinal products [n=2]
‡Bruton's tyrosine kinase inhibitors [n=12], PI3K inhibitors [n=1], BH3-only mimetrics [n=14], VENCLYXTO [n=14], or investigational medicinal products [n=1]
VEN+R=VENCLYXTO®+rituximab; BR=bendamustine + rituximab; ITT=intent to treat; PI3K=phosphoinositide 3-kinase; EoCT=end of combination treatment; EoT=end of treatment.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA. Website: www.hpra.ie.
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References: 1. VENCLYXTO® Summary of Product Characteristics, available at www.medicines.ie 2. Seymour JF et al, Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab. Blood. 2022 May 23. Online ahead of print 3. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120. 4. Kater AP, et al. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study. J Clin Oncol. 2019;37(4):269-277
IE-VNCCLL-220024 | Date of preparation: July 2022
