Note to affiliates: This update to the venetoclax CLL AbbVie Pro site includes a homepage headline, updated CLL14 6-year and MURANO 7-year data sets, and other streamlined content updates. The CLL14 6-year and MURANO 7-year data have been updated based on the EHA 2023 abstracts. For countries that cannot use these data sets, please follow local regulations and MRLO guidance, and revert to CLL14 5-year and MURANO 5-year published data from the product label.
Primary analysis in ITT population for VEN+O vs O+Clb1:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]).
| • | Median follow-up of 28 months |
Additional analyses:
6-year PFS estimate (INV-assessed)2‡: 53% vs 22% (HR=0.40; 95% CI: 0.31–0.52) after 5 years off treatment.
| • | Median PFS of 76.2 months with VEN+O vs 36.4 months with O+Clb |
INV-assessed complete remission (CR/CRi)1: 50% vs 23% (P<0.0001).
| • | ORR: 85% (95% CI: 79.2–89.2) vs 71% (95% CI: 64.8–77.2 [P=0.0007]) |
Primary analysis in ITT population for VEN+R vs BR:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]).
| • | Median follow-up of 23.8 months |
Additional analyses:
7-year PFS estimate (INV-assessed)3‡: 23% (95% CI: 16.1–29.9) vs NE after ~5 years off treatment.
| • | Median PFS of 54.7 months with VEN+R (95% CI: 52.3–59.9) vs 17.0 months with BR (95% CI: 15.5–21.7) |
INV-assessed complete remission (CR/CRi)1‡: 27% vs 8%.
| • | ORR: 93% (95% CI: 88.8–96.4) vs 68% (95% CI: 60.6–74.2) |
*See full dosing information for VEN+O and for VEN+R in the dosing and administration section.
†Primary endpoint.
‡Results are descriptive only.
1L=first line; CLL=chronic lymphocytic leukaemia; VEN+O=VENCLYXTO + obinutuzumab; ITT=intent to treat; O+Clb=obinutuzumab + chlorambucil; INV=investigator; PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; ORR=overall response rate; 2L+=second line + later lines of therapy; VEN+R=VENCLYXTO + rituximab; BR=bendamustine + rituximab; NE=not evaluable.
FIXED-DURATION DOSING REGIMENS IN 1L AND 2L+ CLL1
1L CLL: VENCLYXTO + obinutuzumab is designed to be completed in 1 year
*Oral tablet.
†Administer intravenously. Dose may be split as 100 mg and 900 mg on Days 1 and 2 of Cycle 1, respectively. Graphic not to scale. Each cycle is 28 days.
*Oral tablet.
†Administer intravenously.
Each cycle is 28 days.
*Oral tablet.
†Administer intravenously.
Each cycle is 28 days.
The 5-week VENCLYXTO dose-titration schedule starting on Day 22 of Cycle 1 was designed to gradually reduce tumour burden (debulk) and decrease the risk of TLS.
2L+ CLL: VENCLYXTO + rituximab is designed to be completed in 2 years
‡Oral tablet.
§Administer intravenously.
Each cycle is 28 days.
The initial 5-week dose-titration schedule was designed to gradually reduce tumour burden and decrease the risk of TLS.
Concomitant use of VENCLYXTO with strong or moderate CYP3A inhibitors increases VENCLYXTO exposure and may increase the risk for TLS at initiation and during the dose-titration phase. Inhibitors of P-gp or BCRP may also increase VENCLYXTO exposure.
TLS=tumour lysis syndrome; CYP3A=cytochrome P450 3A; P-gp=P-glycoprotein; BCRP=breast cancer resistance protein.
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 2. AI-Sawaf O, Robrecht S, Zhang C, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. HemaSphere. 2023;7(S3):1-3. 3. Kater A, Harrup R, Kipps TJ, et al. Final 7-year follow up and retreatment substudy analysis of MURANO: venetoclax-rituximab (VENR)-treated patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Abstract presented at the European Hematology Association Congress 2023; June 8-11, 2023; Frankfurt, Germany.
ALL-VNCCLL-220060 May 2024