VENCLYXTO® offers patients with CLL a chance to
BREAK FREE with longer progression-free survival1*†
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
In 2L+ CLL:
VENCLYXTO + rituximab
*Reduced risk of progression or death vs O+Clb (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median follow‑up of 28 months. Median PFS not reached in either arm.
†Reduced risk of progression or death vs BR (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median follow‑up of 23.8 months. Median PFS not reached with VEN+R vs 17 months (15.5–21.6) with BR.
Note to Affiliate:
1. This optional layout includes information based on data from a peer-reviewed publication containing real-world evidence (RWE). The content and timing of presentation of this information must be reviewed according to your local MLRO policy for use of RWE in promotion.
2. This RWE publication data must be presented in conjunction with the primary analysis efficacy and safety data from your approved local label.
The use of VENCLYXTO before BTKi in CLL patients is supported by real-world evidence1*
Multicenter, international, retrospective cohort study across 31 centers (n=326); 188 patients (58%) were treated with a subsequent line of therapy (including BTKi, n=74).
In the patient cohort treated with BTKi after VENCLYXTO†:
ORR: BTKi-naive patients (n=44)
PFS: BTKi-naive patients (n=44)
ORR and PFS: BTKi-exposed patients (n=30)
Discontinuation rate due to AEs was 14.3% for BTKi-naive patients and 8.3% for BTKi-exposed patients.
A retrospective cohort study investigated CLL patients who had discontinued VENCLYXTO (monotherapy, 73%); 4% of patients were treatment-naive and 96% were relapsed/refractory. Primary endpoints were ORR and PFS of treatment following VENCLYXTO discontinuation. ORR was defined by International Workshop on CLL criteria, and PFS as time from post-VENCLYXTO therapy to CLL progression of disease, death, or censored at last follow-up.
BTKi-exposed therapies: ibrutinib, acalabrutinib, noncovalent BTKi.
BTKi-naive therapies: ibrutinib, acalabrutinib.
*Data represent a subset of patients who received BTKi following VENCLYXTO (n=74).
†Patient cohorts were BTKi-exposure (naive/resistant/intolerant), PI3Ki, and cellular therapies.
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; BTKi=Bruton’s tyrosine kinase inhibitor; ORR=overall response rate; CR=complete response; PR=partial response; PR-L=partial response with lymphocytosis; mPFS=median progression-free survival; AE=adverse event; PI3Ki=phosphoinositide 3-kinase inhibitor.
Real-world evidence is collected outside of controlled clinical trials and has inherent limitations, including a lesser ability to control for confounding factors. Results are descriptive and not tested for statistical significance
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Reference: 1. Mato AR, Roeker LE, Jacobs R, et al. Assessment of the efficacy of therapies following venetoclax discontinuation in CLL reveals BTK inhibition as an effective strategy. Clin Cancer Res. 2020;26(14):3589-3596.
GR-VNCCLL-200048 -JAN2021