For Patients and Caregivers

VENCLEXTA regimens were designed to stop after a fixed treatment duration1

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Complete treatment in 1 year
Baseline demographics & characteristics

Break free from chemotherapy and continuous oral treatment in CLL


VENCLEXTA (venetoclax tablets) offers the only chemo-free, oral-based regimen with a fixed duration of 1 year for previously untreated CLL: VEN+G.1

Designed for patients to complete treatment in 1 year1

The CLL14 trial evaluated PFS with VEN+G, a fixed-duration treatment regimen

First line treatment study design chart
  • CLL14 was a multicenter, open-label, actively controlled, phase 3 trial (randomized 1:1)1,2
  • In CLL14, the VEN+G regimen was designed to be completed after 12 months (twelve 28-day treatment cycles)1,2:
    • GAZYVA IV infusion was administered at 1000 mg on Day 1 (the first dose could be split as 100 mg and 900 mg on Days 1 and 2, respectively), and on Days 8 and 15 of Cycle 1. For all subsequent 28-day cycles, GAZYVA 1000 mg was administered on Day 1 for a total of 6 cycles
    • VENCLEXTA oral tablets were administered according to the 5-week dose ramp-up schedule: 20 mg daily during Cycle 1, Days 22-28; 50 mg daily during Cycle 2, Days 1-7; 100 mg daily during Cycle 2, Days 8-14; 200 mg daily during Cycle 2, Days 15-21; 400 mg daily during Cycle 2, Days 22-28; and on Days 1-28 of all subsequent cycles until the end of Cycle 12
    • In the GClb arm of CLL14, GAZYVA was administered in Cycles 1-6; chlorambucil was administered at 0.5 mg/kg orally on Days 1 and 15 of Cycles 1 to 12
       

Select inclusion criteria 

  • Previously untreated CLL with coexisting medical conditions (total CIRS >6 or CrCl <70 mL/min)1,5

Select clinical endpoints

  • Primary endpoint: PFS (IRC-assessed PFS was the basis for FDA approval of VEN+G)1
  • Select secondary endpoints: MRD in bone marrow, CR/CRi (INV-assessed), MRD in peripheral blood, MRD in CR/CRi in bone marrow, MRD in CR/CRi in peripheral blood, ORR (INV-assessed)2,5

After the first treatment cycle of GAZYVA and before the VENCLEXTA dose ramp-up, median ALC was reduced by 98%4

  • Per the trial protocol, tumor burden was assessed based on ALC and lymph node size.1 The effect of the first GAZYVA treatment cycle on lymph node size was not evaluated.4 The trial started with an initial cycle of GAZYVA followed by the 5-week VENCLEXTA dose ramp-up; median lymphocyte count was reduced in the safety evaluable population (N=212) from 55 x 109 cells/L at baseline to 1.27 x 109 cells/L at Day 15. Median lymphocyte counts are descriptive in nature and were not powered by any type of comparison. Changes in TLS risk status based on ALC reduction were at the discretion of the trial investigators

VEN+G was studied in patients whose age and disease characteristics were representative of the broad CLL patient population

Baseline demographics and disease characteristics4*

Characteristic VEN+G (N=216) GClb (N=216)
Age, years; median (range)
 72 (43-89) 71 (41-89)
Age ≥70, % 62 59
Male, %
 68 66
Binet stage, %
Binet stage A 21 20
Binet stage B 36 37
Binet stage C 43 43
Median CIRS score (range)
 9 (0-23) 8 (1-28)
CrCl <70 mL/min, %
 60 55
CLL subsets, %
17p deletion 9 7
TP53 mutation 9 6
11q deletion 18 20
lgVH unmutated 56 57
lgVH mutated 35 38
High TLS risk category, %†
 22 20
Lymph nodes ≥10 cm 5 5
Lymph nodes ≥5 cm to <10 cm and ALC ≥25 x 109/L 14 12
Medium TLS risk, %
 64 68
Low TLS risk, %
 13 12
ECOG performance status, %
0 41 48
1 46 40
2 13 12
Baseline ALC (x 109/L); median
 56 58

*Patients with missing results not included.
†TLS risk category was chosen based on lymph node size, ALC, and investigator discretion.1,5

No clinically meaningful differences in safety and effectiveness were observed between older and younger patients.1

Review a summary of safety data for patients treated with VEN+G from the CLL14 trial

View data

1L=first-line; ALC=absolute lymphocyte count; CIRS=Cumulative Illness Rating Scale; CLL=chronic lymphocytic leukemia; CrCl=creatinine clearance; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; ECOG=Eastern Cooperative Oncology Group; FDA=US Food and Drug Administration; GClb=GAZYVA + chlorambucil; IgVH=immunoglobulin heavy-chain variable gene; INV=investigator; IRC=Independent Review Committee; IV=intravenous; MRD=minimal residual disease; ORR=overall response rate; PFS=progression-free survival; TLS=tumor lysis syndrome; VEN+G=VENCLEXTA + GAZYVA.

NEXT: Progression-Free Survival

US-VENC-230082

Important Safety Information & Indication

Indication

  • VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Important Safety Information

Contraindication

  • Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated in patients with CLL/SLL due to the potential for increased risk of tumor lysis syndrome (TLS).

Tumor Lysis Syndrome

  • Tumor lysis syndrome, including fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA.
  • VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for TLS at initiation and during the ramp-up phase in all patients, and during reinitiation after dosage interruption in patients with CLL/SLL. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase. TLS, including fatal cases, has been reported after a single 20 mg dose.
  • In patients with CLL/SLL who followed the current (5 week) dose ramp-up and the TLS prophylaxis and monitoring measures, the rate of TLS was 2% in the VENCLEXTA CLL/SLL monotherapy trials. The rate of TLS remained consistent with VENCLEXTA in combination with obinutuzumab or rituximab. With a 2- to 3-week dose ramp-up and higher starting dose in patients with CLL/SLL, the TLS rate was 13% and included deaths and renal failure.
  • The risk of TLS is a continuum based on multiple factors, particularly reduced renal function, tumor burden, and type of malignancy. Splenomegaly may also increase the risk of TLS in patients with CLL/SLL.
  • Assess all patients for risk and provide appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Interrupt dosing if needed; when restarting VENCLEXTA follow dose modification guidance in the Prescribing Information.
  • Concomitant use of VENCLEXTA with P-gp inhibitors or strong or moderate CYP3A inhibitors increases venetoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase, and requires VENCLEXTA dose reduction.

Neutropenia

  • In patients with CLL, Grade 3 or 4 neutropenia developed in 63% to 64% of patients and Grade 4 neutropenia developed in 31% to 33% of patients when treated with VENCLEXTA in combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% of patients.
  • Monitor complete blood counts. Interrupt dosing for severe neutropenia and resume at same or reduced dose. Consider supportive measures including antimicrobials and growth factors (e.g., G-CSF).

Infections

  • Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with VENCLEXTA. Monitor patients for signs and symptoms of infection and treat promptly. Withhold VENCLEXTA for Grade 3 and 4 infection until resolution and resume at same or reduced dose.

Immunization

  • Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery occurs. Advise patients that vaccinations may be less effective.

Embryo-Fetal Toxicity

  • VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 30 days after the last dose.

Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone

  • In a randomized trial (BELLINI; NCT02755597) in patients with relapsed or refractory multiple myeloma, the addition of VENCLEXTA to bortezomib plus dexamethasone, a use for which VENCLEXTA is not indicated, resulted in increased mortality. Treatment of patients with multiple myeloma with VENCLEXTA in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

Adverse Reactions

  • In patients with CLL receiving combination therapy with obinutuzumab, serious adverse reactions were most often due to febrile neutropenia and pneumonia (5% each). The most common adverse reactions (≥20%) of any grade were neutropenia (60%), diarrhea (28%), and fatigue (21%). Fatal adverse reactions that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2% (4/212) of patients, most often from infection.
  • In patients with CLL receiving combination therapy with rituximab, the most frequent serious adverse reaction (≥5%) was pneumonia (9%). The most common adverse reactions (≥20%) of any grade were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), and nausea (21%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of the last VENCLEXTA treatment and/or 90 days of the last rituximab were reported in 2% (4/194) of patients.
  • In patients with CLL/SLL receiving monotherapy, the most frequent serious adverse reactions (≥5%) were pneumonia (9%), febrile neutropenia (5%), and sepsis (5%). The most common adverse reactions (≥20%) of any grade were neutropenia (50%), diarrhea (43%), nausea (42%), upper respiratory tract infection (36%), anemia (33%), fatigue (32%), thrombocytopenia (29%), musculoskeletal pain (29%), edema (22%), and cough (22%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of venetoclax treatment were reported in 2% of patients in the VENCLEXTA monotherapy studies, most often (2 patients) from septic shock.

Drug Interactions

  • Concomitant use with a P-gp inhibitor or a strong or moderate CYP3A inhibitor increases VENCLEXTA exposure, which may increase VENCLEXTA toxicities, including the risk of TLS. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions. Resume the VENCLEXTA dosage that was used prior to concomitant use of a P-gp inhibitor or a strong or moderate CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor.
  • Patients should avoid grapefruit products, Seville oranges, and starfruit during treatment as they contain inhibitors of CYP3A.
  • Avoid concomitant use of strong or moderate CYP3A inducers.
  • Monitor international normalized ratio (INR) more frequently in patients receiving warfarin.
  • Avoid concomitant use of VENCLEXTA with a P-gp substrate. If concomitant use is unavoidable, separate dosing of the P-gp substrate at least 6 hours before VENCLEXTA.

Lactation

  • Advise women not to breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

Females and Males of Reproductive Potential

  • Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.
  • Based on findings in animals, VENCLEXTA may impair male fertility.

Hepatic Impairment

  • Reduce the dose of VENCLEXTA for patients with severe hepatic impairment (Child-Pugh C); monitor these patients more frequently for adverse reactions. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information.

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VENCLEXTA® and its design are registered trademarks of AbbVie Inc.
GAZYVA® is a registered trademark of Genentech, Inc.

    • VENCLEXTA Prescribing Information.

      VENCLEXTA Prescribing Information.

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      Seymour JF, Kipps TJ, Eichhorst B, et al. Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab. Blood. 2022;140(8):839​-850.

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