For Patients and Caregivers

VENCLEXTA efficacy results: durable progression-free survival without long-term treatment1‎

PFS

VEN+G demonstrated durable PFS without long-term treatment1‎

CLL14: In a randomized (1:1), multicenter, actively controlled, open-label, phase 3 trial (CLL14), VEN+G was studied against GClb in 432 patients with previously untreated CLL with comorbid medical conditions (total CIRS score >6 or CrCl <70 mL/min). The primary endpoint was progression-free survival (PFS). See full study design.1,2

IRC-assessed PFS (primary endpoint) in previously untreated CLL

reduction in risk of progression or death vs GClb

(HR=0.33; 95% Cl: 0.22-0.51 [P<0.0001])

After a median follow-up of 28 months (range: 0-36 months):

  • There were 29 events in the VEN+G arm (14 progressions and 15 deaths without disease progression) compared with 79 events in the GClb arm (71 progressions and 8 deaths without disease progression)*
  • Median PFS was not reached in either arm
6-Year Follow-Up

6-year follow-up analyses26,27†

INV-assessed PFS (median follow-up of 76.4 months; range 0-86.5)

  • PFS estimates may be unreliable at the tail end of the curve due to smaller number of patients at risk

The PFS follow-up analysis was not tested for statistical significance

  • Of the 101 events in the VEN+G arm, 67 were disease progression and 34 were deaths without disease progression. Of the 161 events in the GClb arm, 141 were disease progression and 20 were deaths without disease progression

*Number of events based on earliest event of disease progression or deaths without disease progression due to any cause.1
†Based on data as of clinical cutoff date of November 14, 2022; time of analysis was not pre-specified.

TTNT

Time to next treatment26,27‡

Actual rates at the time of the 6-year analysis§:

~6 out of 10 patients in the VEN+G arm had not received subsequent treatment
vs 35% of patients in the GClb arm (76/216)
  • The decision to initiate next therapy was made by the treating physician and patient, which can be a limitation to this analysis
  • Rates do not account for censoring
The TTNT follow-up analysis was not tested for statistical significance.

‡Time to next treatment (TTNT) was defined as the time from randomization to start of a new CLL therapy or death.
§Based on data as of clinical cutoff date of November 14, 2022; time of analysis was not pre-specified.

Response Rates

VENCLEXTA efficacy results: impressive response rates1

INV-assessed response rates for VEN+G (N=216) vs GClb (N=216), respectively (secondary endpoint)1¶#

  • ORR: 85% (n=183; 95% CI: 79-89) with VEN+G vs 71% (n=154; 95% CI: 65-77) with GClb; P=0.0007
  • CR: 46% (n=100) with VEN+G vs 22% (n=47) with GClb
  • PR: 35% (n=76) with VEN+G vs 48% (n=104) with GClb

Per the 2008 iwCLL guidelines.
#Assessed 3 months after treatment completion.

uMRD

VENCLEXTA efficacy results: undetectable minimal residual disease (uMRD)

Achieving uMRD in CLL means a patient has no detectable cancer cells, at a threshold of <1 detectable CLL cell per 10,000 leukocytes13

Tumor burden

Decreasing detectable CLL cells in peripheral blood and/or bone marrow

Undetectable MRD (uMRD) rates1

uMRD in peripheral blood in the ITT population (secondary endpoint)

  • The rate of uMRD in bone marrow was 57% (123/216) for VEN+G (95% CI: 50-64) and 17% (37/216) for GClb (95% CI: 12-23) in the ITT population; P<0.0001

91% concordance: Of the 134 patients in the VEN+G arm with uMRD in peripheral blood who had matching bone marrow specimens, 122 patients had uMRD in bone marrow.

  • In patients with a CR, the rate of uMRD in peripheral blood was 87% (87/100) for VEN+G (95% CI: 79-93) and 62% (29/47) for GClb (95% CI: 46-75); P=0.0005
  • MRD was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) 3 months after treatment ended. uMRD was defined as having achieved <1 CLL cell per 10,000 leukocytes1
  • While uMRD and response rates are both measures of disease, it is possible for a patient with a PR to be MRD negative, and for a patient with a CR to be MRD positive14
  • The FDA does not yet consider MRD an established surrogate endpoint for clinical outcomes in patients with CLL15

Rates of uMRD|| in peripheral blood in evaluable patients in the VEN+G arm4

  • Of evaluable GClb patients, 42% achieved uMRD (76/182)4
  • The population with evaluable results (n=369) excludes results missing due to progressive disease (PD), withdrawal (including withdrawal due to toxicity), deaths without disease progression, MRD status unknown, and other missing samples or assessments
  • Not prespecified or tested for statistical significance

||Assessed 3 months after treatment completion.2
**Evaluable patients.4

6-Year Follow-Up OS

VENCLEXTA efficacy results: 6-year overall survival26,27††

INV-assessed OS (median follow-up of 76.4 months)

With a median follow-up of 76.4 months (range 0.0-86.5):

  • Median OS was not reached in either arm
  • The rates of death were 22% (n=48) in the VEN+G arm and 32% (n=70) in the GCIb arm (HR=0.69; 95% CI: 0.48-1.01)
  • The OS follow-up analysis was not tested for statistical significance and OS benefit could not be concluded
  • OS estimate may be unreliable at the tail end of the curve due to smaller number of patients at risk

††Based on data as of clinical cutoff date of November 14, 2022; time of analysis was not pre-specified.

Real-World Persistence

Persistence‡‡ with VENCLEXTA + GAZYVA® (obinutuzumab) and BTKi-based therapy10

A real-world study of 1484 patients with previously untreated CLL/SLL given venetoclax + obinutuzumab or 1st- or 2nd-generation BTKis as monotherapy or in combination, specifically ibrutinib, acalabrutinib, and zanubrutinib

Limitations

  • Efficacy, safety, and reasons for discontinuation cannot be determined via administrative claims data
  • The presence of a claim for a filled prescription may not indicate actual use of the drug per its approved label
  • Lines of therapy and duration of therapy are derived (typical with administrative claims or EHR databases) and not based on chart review, and therefore, they may be subject to misclassification. During BTKi-based therapy, patients may have had a drug holiday or a treatment switch due to intolerance or disease progression
  • Results from real-world data studies may differ from findings from clinical trials

Study design

  • Real-world prescription refill persistence in 1484 adults from the Optum Clinformatics® Data Mart was evaluated (BTKi-based therapy=1212; VEN+G=272). BTKis included in this study were ibrutinib, acalabrutinib, and zanubrutinib. Data include patients’ medical and pharmacy utilization (eg, dates of service, drug description, quantity dispensed)
  • Median follow-up—VEN+G cohort: 29.0 months; BTKi-based therapy cohort: 28.0 months
  • Inclusion criteria: Adults with ≥2 medical claims for CLL with no prior therapy who initiated a combination regimen of venetoclax + obinutuzumab or BTKi-based therapy approved for previously untreated CLL/SLL between December 2019 and March 2024, and had continuous insurance enrollment for ≥3 years prior to and ≥1 year after initiation of CLL therapy (≥2 claims for treatment)
  • Exclusion criteria: Patients with AML, MZL, MCL, and WM
  • Cohorts were balanced using stabilized inverse probability of treatment weighting (IPTW). Kaplan-Meier method was used to calculate the adjusted duration of therapy for each venetoclax + obinutuzumab and BTKi-based therapy cohort

Outcome definition

  • Persistence captures patients’ duration of treatment, which is defined as the time from index date of 1L treatment initiation until a gap of >90 days, death, or start of subsequent treatment. Patients who do not experience any of these events will be censored at the end of continuous enrollment

‡‡Percentages shown represent the probabilities of staying on or stopping treatment.
§§11 months (VEN+G regimen is completed in 11.2 months or twelve 28-day cycles).
¶¶BTKis are prescribed to be taken until disease progression/intolerability (BTKi cohort that discontinued N=671: Acala=261; Acala+G=25; I=322; I+G=2; I+R=21; Z=40.

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

1L=first-line; A=acalabrutinib; AML=acute myeloid leukemia; BTKi=Bruton’s tyrosine kinase inhibitor; EHR=electronic health record; G=GAZYVA® (obinutuzumab); I=ibrutinib; MCL=mantle cell lymphoma; MZL=marginal zone lymphoma; R=rituximab; WM=Waldenström macroglobulinemia; VEN=VENCLEXTA; Z=zanubrutinib.

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VENCLEXTA +
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US-VENC-250248

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 the 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 monotherapy and in combination studies with obinutuzumab or rituximab; febrile neutropenia occurred in 4% to 6% of patients. Grade 3 or 4 neutropenia developed in 38% of patients and Grade 4 neutropenia developed in 15% of patients when treated with VENCLEXTA in combination with acalabrutinib; febrile neutropenia occurred in 2% 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.
  • In AMPLIFY, a randomized study in patients with previously untreated CLL/SLL, serious or Grade 3 or higher infections occurred in 14% of patients who received VENCLEXTA in combination with acalabrutinib (VEN+A), most commonly due to COVID-19; fatal infections occurred in 3.1% of patients.
  • In an additional cohort of patients receiving VENCLEXTA in combination with acalabrutinib and obinutuzumab (AVO) (an unapproved regimen for previously untreated CLL/SLL in AMPLIFY), serious or Grade 3 or higher infections occurred in 25%, most commonly due to COVID-19; fatal infections occurred in 6% of patients. The safety and effectiveness of AVO have not been established by the FDA in patients with previously untreated CLL/SLL.

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 acalabrutinib, serious adverse reactions were most often due to COVID-19 including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%). The most common adverse reactions (≥20%) of any grade were neutropenia (78%), headache (35%), diarrhea (33%), musculoskeletal pain (25%), and COVID-19 (21%). Fatal adverse reactions occurred in 3.4% of patients, most often from COVID-19 and COVID-19 pneumonia.
  • 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.

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. Concomitant use with a strong CYP3A inhibitor at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions in patients taking a steady daily dosage (after ramp-up phase). 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.

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

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