ALL-ORAL
What does treatment with VENCLEXTA + acalabrutinib offer?
With a VENCLEXTA-based regimen,
a treatment-free period is possible
Actor portrayals.
You and your doctor have the choice between two different VENCLEXTA-based regimens
VENCLEXTA + acalabrutinib is the first and only all-oral CLL treatment designed to be completed in 14 months (fourteen 28-day cycles) – so a progression-free, treatment-free period is possible
VENCLEXTA + acalabrutinib was studied in a clinical trial
In a clinical study of people who had not been treated for CLL, VENCLEXTA was studied in combination with a BTK inhibitor called acalabrutinib. This regimen is all-oral and is not a chemotherapy, and was studied against a commonly used chemotherapy-containing regimen. 291 patients received VENCLEXTA + acalabrutinib and 290 received a chemotherapy-containing regimen (fludarabine+cyclophosphamide+rituximab or bendamustine+rituximab). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.
A significantly lower chance of disease worsening or death
In a clinical trial with 41 months median follow-up, the chance of disease worsening or death was 35% lower with the VENCLEXTA regimen (291 people) compared to a chemotherapy-containing regimen (290 people). Doctors generally call this progression-free survival or PFS.
The median PFS was not reached for VENCLEXTA + acalabrutinib in the study but the median PFS for the chemotherapy containing regimen was 47.6 months. This was based on median follow-up of approximately 41 months for patients in the VENCLEXTA + acalabrutinib arm of the study. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.
More than half of patients were progression-free and treatment-free 2 years after finishing their treatment.
The trial was designed to assess efficacy over time rather than at a specific timepoint after completing treatment.
VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please click here for additional Important Safety Information.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.
Individual results may vary.
Actor portrayals.
Prepare to have a more open and informed conversation with your doctor.
Prepare to have a more open and informed conversation with your doctor.
ORAL + INFUSION
What does treatment with VENCLEXTA + GAZYVA offer?
VENCLEXTA + GAZYVA is a CLL treatment designed to be completed in 12 months, so a progression-free, treatment-free period is possible
VENCLEXTA + GAZYVA was studied in a clinical trial
In a clinical study of 432 people who had not been treated for CLL, VENCLEXTA was studied with an antibody treatment called GAZYVA. This regimen is not a chemotherapy and was studied against a commonly used chemotherapy-containing regimen. Half of the patients (216) received VENCLEXTA + GAZYVA and the other half received the chemotherapy-containing regimen (chlorambucil and GAZYVA). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.
A significantly lower chance of disease worsening or death
In a clinical trial with a 28-month median* follow-up, the chance of disease worsening or death was 67% lower with the VENCLEXTA regimen (216 people) than with the chemotherapy-containing regimen (216 people). Doctors generally call this progression-free survival or PFS.
35%
lower chance of disease progression or death compared to chemotherapy-containing regimen
In a clinical trial with 43 months median follow-up, the chance of disease worsening or death was 35% lower with the VENCLEXTA regimen (291 people) compared to a chemotherapy-containing regimen (290 people). Doctors generally call this progression-free survival or PFS.
A majority of patients were still progression-free and treatment-free 2 years after finishing their treatment.
In a clinical study of people who had not been treated for CLL, VENCLEXTA was studied in combination with a BTK inhibitor called acalabrutinib. This regimen is all oral and is not a chemotherapy and was studied against a commonly used chemotherapy-containing regimen. 291 patients received VENCLEXTA + acalabrutinib and the other half (290) received a chemotherapy-containing regimen (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.
Please take note that the median PFS was not reached for VENCLEXTA + acalabrutinib in the study. This was based on median follow-up of approximately 43 months. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.
VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please click here for additional Important Safety Information.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.
Individual results may vary.
At the primary analysis, the median PFS was not reached for either regimen in the study. This was based on median follow-up of 28 months. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.
In a later follow-up analysis, more than half of patients were progression-free and treatment-free 5 years after finishing their treatment.
The trial was designed to assess efficacy over time rather than at a specific timepoint after completing treatment.
VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please click here for additional Important Safety Information.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.
Individual results may vary.
Actor portrayals.
Remission defined
Remission means that the signs of cancer have lessened or are no longer detectable, although cancer may still be in the body.
Complete remission means that all signs and symptoms of cancer have disappeared for a period of time, but cancer may still be in the body.
Complete remission with incomplete marrow recovery means that most signs and symptoms of cancer disappeared for a period of time except that platelet, white blood cell, or red blood cell counts remained low.
Partial remission means that there are still signs of cancer, but your treatment regimen is working because the number of cancer cells in your body has greatly decreased.
Remission with the confidence to stop treatment with VENCLEXTA + GAZYVA
The remission rates people in the clinical trial experienced 3 months after completing treatment were:
- 85% of people achieved some level of remission (183 of 216 people) with VENCLEXTA + GAZYVA compared to 71% (154 of 216 people) of people with chlorambucil and GAZYVA
- 50% of people achieved complete remission or complete remission with incomplete marrow recovery (107 of 216 people) with VENCLEXTA + GAZYVA compared to 23% (50 of 216 people) with chlorambucil and GAZYVA
- 35% of people achieved a partial remission (76 of 216 people) with VENCLEXTA + GAZYVA compared to 48% (104 of 216 people) of people with chlorambucil and GAZYVA
Complete remission is possible
In the clinical study, 50% of people with previously untreated CLL achieved complete remission or complete remission with incomplete marrow recovery (107 of 216 people) with VENCLEXTA + GAZYVA compared to 23% (50 of 216 people) with the chemotherapy-containing regimen at 3 months after treatment completion.
35%
lower chance of disease progression or death compared to chemotherapy-containing regimen
In a clinical trial with 43 months median follow-up, the chance of disease worsening or death was 35% lower with the VENCLEXTA regimen (291 people) compared to a chemotherapy-containing regimen (290 people). Doctors generally call this progression-free survival or PFS.
A majority of patients were still progression-free and treatment-free 2 years after finishing their treatment.
In a clinical study of people who had not been treated for CLL, VENCLEXTA was studied in combination with a BTK inhibitor called acalabrutinib. This regimen is all oral and is not a chemotherapy and was studied against a commonly used chemotherapy-containing regimen. 291 patients received VENCLEXTA + acalabrutinib and the other half (290) received a chemotherapy-containing regimen (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.
Please take note that the median PFS was not reached for VENCLEXTA + acalabrutinib in the study. This was based on median follow-up of approximately 43 months. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.
VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please click here for additional Important Safety Information.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.
Individual results may vary.
You can be free from detectable disease in the blood
After completing treatment with VENCLEXTA + GAZYVA, 76% of people with previously untreated CLL had such a low level of CLL cells in their blood (fewer than 1 cancer cell per 10,000 white blood cells) that the cancer cells were not detectable using a sensitive clinical test compared to 35% of people treated with chlorambucil and GAZYVA. This is known as undetectable minimal residual disease (MRD) or MRD negativity.
Please take note that undetectable MRD or MRD negativity does not necessarily equal successful treatment due to limitations with MRD testing. For instance, it is possible for patients to have a partial response to treatment while still testing as MRD negative and patients can have a complete response and be MRD positive.
Individual results may vary.
Complete remission is possible
3 months after completing treatment
In the clinical study, 50% of people with previously untreated CLL achieved complete remission or complete remission with incomplete marrow recovery (107 of 216 people) with VENCLEXTA + GAZYVA compared to 23% (50 of 216 people) with the chemotherapy-containing regimen at 3 months after treatment completion.
35%
lower chance of disease progression or death compared to chemotherapy-containing regimen
In a clinical trial with 43 months median follow-up, the chance of disease worsening or death was 35% lower with the VENCLEXTA regimen (291 people) compared to a chemotherapy-containing regimen (290 people). Doctors generally call this progression-free survival or PFS.
A majority of patients were still progression-free and treatment-free 2 years after finishing their treatment.
In a clinical study of people who had not been treated for CLL, VENCLEXTA was studied in combination with a BTK inhibitor called acalabrutinib. This regimen is all oral and is not a chemotherapy and was studied against a commonly used chemotherapy-containing regimen. 291 patients received VENCLEXTA + acalabrutinib and the other half (290) received a chemotherapy-containing regimen (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.
Please take note that the median PFS was not reached for VENCLEXTA + acalabrutinib in the study. This was based on median follow-up of approximately 43 months. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.
VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please click here for additional Important Safety Information.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.
Individual results may vary.
You can be free from detectable disease in the blood
After completing treatment with VENCLEXTA + GAZYVA, 76% of people with previously untreated CLL had such a low level of CLL cells in their blood that the cancer cells were not detectable using a sensitive clinical test compared to 35% of people treated with chlorambucil and GAZYVA. This is known as undetectable minimal residual disease (MRD) or MRD negativity.
Please take note that undetectable MRD or MRD negativity does not necessarily equal successful treatment due to limitations with MRD testing. For instance, it is possible for patients to have a partial response to treatment while still testing as MRD negative and patients can have a complete response and be MRD positive.
Individual results may vary.
Complete remission is possible
2X higher complete remission rate compared to chemotherapy
3 months after completing treatment
In the clinical study, 50% of people with previously untreated CLL achieved complete remission or complete remission with incomplete marrow recovery (107 of 216 people) with VENCLEXTA + GAZYVA compared to 23% (50 of 216 people) with the chemotherapy-containing regimen at 3 months after treatment completion.
You can be free from detectable disease in the blood
After completing treatment with VENCLEXTA + GAZYVA, 76% of people with previously untreated CLL had such a low level of CLL cells in their blood that the cancer cells were not detectable using a sensitive clinical test compared to 35% of people treated with chlorambucil and GAZYVA. This is known as undetectable minimal residual disease (MRD) or MRD negativity.
Please take note that undetectable MRD or MRD negativity does not necessarily equal successful treatment due to limitations with MRD testing. For instance, it is possible for patients to have a partial response to treatment while still testing as MRD negative and patients can have a complete response and be MRD positive.
Individual results may vary.
Actor portrayals.
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