For Patients and Caregivers

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

PFS

VEN+R demonstrated durable PFS without long-term treatment1*

MURANO: In a randomized (1:1), multicenter, actively controlled, open-label, phase 3 trial (MURANO), VEN+R was studied against bendamustine in combination with rituximab (BR) in 389 patients with CLL who had received at least one line of prior therapy. The primary endpoint was progression-free survival. See full study design.1,6

IRC-assessed PFS (primary endpoint) in R/R CLL

reduction in risk of progression or death vs BR

(HR=0.19; 95% Cl: 0.13-0.28 [P<0.0001])

After a median follow-up of 23.4 months (range: 0-37.4+ months):

  • There were 35 events in the VEN+R arm (26 progressions and 9 deaths without disease progression) compared with 106 events in the BR arm (91 progressions and 15 deaths without disease progression)†
  • The median PFS was not reached with VEN+R vs 18.1 months (95% CI: 15.8-22.3) with BR

*VEN+R is designed to be completed in 24 months from Cycle 1, Day 1 of rituximab, in the absence of disease progression or unacceptable toxicity.1
†Number of events based on earliest event of disease progression or deaths without disease progression due to any cause.1

7-Year Follow-Up

7-year follow-up analyses28,29‡

INV-assessed PFS (median follow-up of 85.7 months)

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

With a median follow-up of 85.7 months (range: 0.0-99.2 months):

  • There were 136 events in the VEN+R arm (117 progressions and 19 deaths without disease progression)
  • There were 173 events in the BR arm (154 progressions and 19 deaths without disease progression)

‡Based on data as of clinical cutoff date of August 3, 2022; time of analysis was not prespecified.

TTNT

Time to next treatment28,29§

Actual rates at the time of the 7-year analysis||:

~4 out of 10 patients in the VEN+R arm had not received subsequent treatment
vs 18% (36/195) of patients in the BR arm
  • 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 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 August 3, 2022; time of analysis was not pre-specified.

Response Rates

VENCLEXTA efficacy results: impressive response rates1

IRC-assessed response rates for VEN+R (N=194) vs BR (N=195), respectively (secondary endpoint)1‎

  • CR+CRi: 8% (n=16) vs 4% (n=7)
  • PR: 82% (n=160) vs 68% (n=133)
  • nPR: 2% (n=3) vs 1% (n=1)
  • Response rates were assessed per 2008 iwCLL guidelines
  • INV-assessed ORR for VEN+R was 93% (n=181; 95% CI: 89-96) compared with 68% (n=132; 95% CI: 61-74) in the BR arm8
  • INV-assessed CR/CRi for VEN+R was 27% (n=52) compared with 8% (n=16) in the BR arm8
  • INV-assessed vs IRC-assessed CR/CRi discordance was primarily due to interpretation of residual adenopathy on CT scans; specifically, 33 out of 51 patients across both arms with discordance had lesions ≤3 cm despite bone marrow clearance6,7

Key secondary endpoints were ranked for hierarchical testing as: (1) IRC-assessed CR/CRi rate, and (2) IRC-assessed ORR, and (3) OS. Because the study did not reach significance at the first key secondary endpoint (IRC-assessed CR/CRi rate), the remaining key secondary endpoints could not be tested for statistical significance.7

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) rates

uMRD in peripheral blood in the ITT population (secondary endpoint)1

  • The MRD-negative CR+CRi rate was 3% (6/194) in the VEN+R arm and 2% (3/195) in the BR arm1
  • Not tested for statistical significance
  • MRD was evaluated using ASO-PCR 3 months after the last dose of rituximab. uMRD was defined as having achieved <1 CLL cell per 10,000 leukocytes7
  • 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 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 undetectable MRD# in peripheral blood in evaluable patients in the VEN+R arm33

  • Of evaluable BR patients, 25% achieved uMRD (23/91), and 75% were MRD positive (68/91)
  • The population with evaluable results (n=233) excludes results missing due to progressive disease, withdrawal (including withdrawal due to toxicity), deaths, MRD status unknown, and other missing samples or assessments
  • Not prespecified or tested for statistical significance

Patients who achieved a PR or better.
#Assessed 3 months after the last dose of rituximab.1
||The number of patients in the VEN+R arm with undetectable MRD is based on the EoCT MRD status at the clinical cutoff date of May 8, 2017, where 1 patient wasn’t categorized as negative due to missing EoCT response visit.

7-Year Follow-Up OS

VENCLEXTA efficacy results: 7-year overall survival**28,29,32,34

Follow-up analyses of overall survival**28,29

INV-assessed OS (median follow-up of 85.7 months)

With a median follow-up of 85.7 months (range 0.0-99.2)

  • Median OS was not reached for the VEN+R arm and was 87.8 months (95% CI: 70.1-NE) in the BR arm
  • The rates of death were 31% (n=60) in the VEN+R arm and 43% (n=84) in the BR arm
    • Stratified HR=0.53; 95% CI: 0.37-0.74
  • The OS follow-up analysis was not tested for statistical significance
  • OS estimates 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 August 3, 2022; time of analysis was not pre-specified.29

Subsequent Treatment

Treatment after VEN+R at the 7-year follow-up32,34

In a 7-year follow-up analysis of the VEN+R patient cohort, 95/194 (49%) of patients received subsequent therapy with modalities that included:

Subsequent therapies also included CIT (n=14) and Other (n=2).

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

1L=first-line; ASO-PCR=allele-specific oligonucleotide polymerase chain reaction; BCL2i=B-cell lymphoma 2 inhibitor; BR=bendamustine + rituximab; BTK=Bruton tyrosine kinase; BTKi=Bruton’s tyrosine kinase inhibitor; CI=confidence interval; CIT=chemoimmunotherapy; CLL=chronic lymphocytic leukemia; CR=complete remission; CRi=complete remission with incomplete count recovery; CT=computed tomography; EoCT=end of combination therapy; HR=hazard ratio; INV=investigator; IRC=Independent Review Committee; ITT=intent to treat; iwCLL=International Workshop on Chronic Lymphocytic Leukemia; MRD=minimal residual disease; NE=not evaluable; nPR=nodular partial remission; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response; R/R=relapsed/refractory; TTNT=time to next treatment; uMRD=undetectable minimal residual disease; VEN+G=VENCLEXTA + GAZYVA; VEN+R=VENCLEXTA + rituximab.

NEXT: 1L: VEN+G Safety Profile

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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      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)(suppl):839​-850.

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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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