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CLL14 trial was designed to allow patients to complete treatment in 1 year1*
CLL14 evaluated VENCLYXTO + obinutuzumab vs a standard CIT regimen (obinutuzumab + chlorambucil)
*CLL14 was a multicenter, open-label, phase 3 trial. Treatment complete after twelve 28-day cycles.
†VENCLYXTO 400 mg daily after initial dose-titration period.
‡Obinutuzumab dosing: 100 mg Cycle 1, Day 1, followed by 900 mg on Days 1 or 2; 1000 mg on Days 8 and 15 and Day 1 of subsequent cycles.
§Chlorambucil dosing: 0.5 mg/kg on Days 1 and 15 of each 28-day cycle.
Click here for more information about titration protocols and full dosing.
Select inclusion criteria
- Previously untreated CLL, coexisting medical conditions (total CIRS >6 or CrCl <70 mL/min), age ≥18 years
Select clinical endpoints
- Primary endpoint: INV-assessed PFS||
- Select secondary endpoints: IRC-assessed PFS,|| ORR,¶ CR+CRi,|| PR,|| and MRD negativity# rate at end of treatment
The median follow-up time at the time of the primary analysis was 28 months (range: 0–36 months).
||Assessed using the International Workshop for Chronic Lymphocytic Leukemia (iwCLL) updated National Cancer Institute–sponsored Working Group (NCI-WG) guidelines (2008).
¶ORR=CR+CRi+PR.
#MRD negativity was assessed at the end of treatment. MRD was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR). The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes.
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; CIT=chemoimmunotherapy; IV=intravenous; CIRS=Cumulative Illness Rating Scale; CrCl=creatinine clearance; INV=investigator; IRC=independent review committee; ORR=overall response rate; CR=complete remission; CRi=complete remission with incomplete marrow recovery; PR=partial response; MRD=minimal residual disease.
VENCLYXTO + obinutuzumab induced deep responses* in the majority of patients1
The median follow-up time at the time of the primary analysis was 28 months (range: 0–36 months).
High rate of complete remission1,2†
More than twice as many patients in the VEN+O arm (50%) had complete remission (CR+CRi) vs the O+Clb arm (23%) (P<0.0001).
- ORR‡ was 85% (95% CI: 79.2–89.2) in the VEN+O arm vs 71% (95% CI: 64.8–77.2) in the O+Clb arm (P=0.0007)
*Deep response as indicated by CR or MRD negativity.
†Assessed 3 months after treatment completion.2
‡ORR=CR+CRi+PR (secondary endpoint).1
High rates of MRD negativity§ in the VEN+O arm1
- Rates of MRD negativity in peripheral blood at the end of combination treatment were 2 times higher in the VEN+O arm (76% [95% CI: 69.2–81.1]) than in the O+Clb arm (35% [95% CI: 28.8–42.0]) (ITT population) (P<0.0001)1,2
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- Rates of MRD negativity in bone marrow at the end of combination treatment were 3 times higher in the VEN+O arm (57% [95% CI: 50.1–63.6]) than in the O+Clb arm (17% [95% CI: 12.4–22.8]) (ITT population) (P<0.0001)1,2||
§The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes (secondary endpoint).1
||Per protocol, MRD in bone marrow was to be assessed only in responding patients (CR/CRi and PR).1
VEN+O=VENCLYXTO + obinutuzumab; ITT=intent to treat.
The PFS benefit of VENCLYXTO + obinutuzumab vs O+Clb was sustained at 3-year follow-up1
INV-assessed progression-free survival (primary analysis)
- 1-year PFS estimate: 95% (95% CI: 91.5–97.7) with VEN+O vs 92% (95% CI: 88.4–95.8) with O+Clb
- 2-year PFS estimate: 88% (95% CI: 83.7–95.1) with VEN+O vs 64% (95% CI: 57.4–70.8) with O+Clb
Median follow-up of 28 months (range: 0–36 months; VEN+O: n=216, O+Clb: n=216) (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median PFS was not reached in either arm.
Use VENCLYXTO + obinutuzumab at the earliest indicated opportunity in your patients with previously untreated CLL1
The information on this page is based on “Fischer K, Al-Sawaf O, Bahlo J, et al; N Engl J Med 2019” supplementary information and is not included in the SmPC. Use of this subset analysis should be evaluated by affiliate Med/Reg review based on local regulations and policy.
VENCLYXTO + obinutuzumab PFS benefit was consistent across subgroups of interest3*
Data cutoff: 17 August 2018.1
*The INV-assessed PFS subgroup analyses were exploratory only, with no reporting of any P values from statistical testing procedures.
TP53=tumor protein 53; IgVH=immunoglobulin heavy-chain variable gene.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.> 2. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. 3. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236(suppl appendix).