Study Results | ZYNLONTA® (loncastuximab tesirine-lpyl) Patient Site

As seen in the clinical trial, which included 145 people who tried 2 or more past diffuse large B-cell lymphoma (DLBCL) treatments,

Diffuse Large B-Cell Lymphoma (DLBCL) — A type of B-cell non-Hodgkin lymphoma (cancer of the immune system) that is usually aggressive (fast-growing). It is the most common type of non-Hodgkin lymphoma, and is marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs.

 

 

ZYNLONTA® Delivered Results for Some People with Relapsed/Refractory (R/R) DLBCL

As seen in the clinical trial, which included 145 people who tried 2 or more past diffuse large B-cell lymphoma (DLBCL) treatments,

Diffuse Large B-Cell Lymphoma (DLBCL) — A type of B-cell non-Hodgkin lymphoma (cancer of the immune system) that is usually aggressive (fast-growing). It is the most common type of non-Hodgkin lymphoma, and is marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs.

 

 

ZYNLONTA® Delivered Results for Some People with Relapsed/Refractory (R/R) DLBCL

Not an actual patient.

ZYNLONTA® was specifically studied in adults who needed their next DLBCL therapy option after trying 2 or more past therapies

ZYNLONTA® is for people living with…

Relapsed cancer:

The cancer came back after past therapies worked

OR

Refractory cancer:

Therapy/therapies have not worked or no longer work

Ask your doctor if ZYNLONTA® is right for you.

ZYNLONTA® was effective for many people who had past R/R DLBCL therapies

The ZYNLONTA® clinical trial included people who had already received a variety of DLBCL therapies, including:

  • Chemotherapy icon
    Chemotherapy

    Chemotherapy — Treatment to stop the growth of cancer cells by killing the cells or by stopping them from dividing. It may be given by mouth, injection, infusion, or on the skin, depending on the type and stage of the cancer being treated. It may be given alone or with other treatments.

     
  • RITUXAN® (rituximab) icon
    RITUXAN® (rituximab)

    RITUXAN® (rituximab) — A drug used alone or with other drugs to treat certain types of B-cell non-Hodgkin lymphoma, and some leukemias. Rituximab is also being studied in the treatment of other conditions and types of cancer. Rituximab binds to a protein called CD20, which is found on B-cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Rituximab is a type of monoclonal antibody (also called mAb).

     
  • CAR-T Therapy icon
    CAR-T therapy

    CAR-T therapy — A type of treatment in which a person’s T cells (a type of immune system cell) are changed in a laboratory so they will attack cancer cells. T cells are taken from a person’s blood. Then, the gene for a special receptor, called a chimeric antigen receptor (CAR), that binds to a certain protein on the person’s cancer cells is added to the T cells. Large numbers of the CAR T cells are grown in the laboratory and given to the person by infusion. CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.

     
  • Stem cell transplant icon
    Stem cell transplant

    Stem cell transplant — A procedure in which a person receives healthy stem cells (blood-forming cells) to replace their own stem cells that have been damaged by treatment with radiation or high doses of chemotherapy. The healthy stem cells may come from the blood or bone marrow of the patient or from a related or unrelated donor. A stem cell transplant may be autologous (using a patient’s own stem cells that were collected and saved before treatment), allogeneic (using stem cells from a related or unrelated donor), syngeneic (using stem cells donated by an identical twin), or cord blood (using umbilical cord blood donated after a baby is born).

     

The trial included 145 people with R/R DLBCL. It studied how well ZYNLONTA® worked for them. The people in the trial were chosen to be in it because the cancer either returned (relapsed cancer), or did not respond to past therapy (refractory) after 2 therapies.

Study results infographicStudy results infographic

About the people in the study for ZYNLONTA®

  • They had R/R large B-cell lymphoma. Most (88%) had a type of disease called DLBCL not otherwise specified (NOS)
    • Some had types of lymphoma that are difficult to treat. These included DLBCL arising from slow-growing lymphoma (20%), or fast-growing B-cell lymphoma (8%)
  • Age range was from 23 to 94 (median: 66). More than half (59%) were male. Most were Caucasian (90%)
  • Patients had at least 2, and as many as 7 treatments before ZYNLONTA®
    • Some had a previous stem cell transplant (17%), while some had received CAR T-cell therapy (9%)
    • More than half of patients (63%) did not respond to their previous treatment
  • 68 people who received ZYNLONTA® in the trial went on to other therapies after the trial. Some of these people did not respond to Zynlonta®. Out of those 68:
    • 9 people got SCT
    • 15 people got CAR-T after their cancer worsened
    • The safety and efficacy outcomes for the people who left the trial and went on to other therapies have not been confirmed with a randomized trial

      Randomized trial — A study in which people are randomly divided in to separate groups to see how well the therapies work.

       

       

Every person is unique. How your condition progresses and how you may respond to ZYNLONTA®
depends on your individual circumstances. Talk with your doctor to learn more about ZYNLONTA®

Learn how
ZYNLONTA® is given

ZYNLONTA® infusions icon
Learn about ZYNLONTA® infusions

ZYNLONTA® may cause
side effects

Side effects icon
Read up on possible side effects
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What is ZYNLONTA®?

ZYNLONTA® is a prescription medicine used to treat adults with certain types of large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer.

It is not known if ZYNLONTA® is safe and effective in children.

The approval of ZYNLONTA® is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of ZYNLONTA®.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of ZYNLONTA®?

ZYNLONTA® may cause serious side effects, including:

  • Fluid retention. Your body may hold too much fluid during treatment with ZYNLONTA®. This can be serious. Tell your healthcare provider if you develop new or worsening swelling or puffiness, weight gain, chest pain, shortness of breath, or trouble breathing
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with ZYNLONTA® but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with ZYNLONTA®. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding
  • Read full Important Safety Information
  • Infections. Serious infections, including infections that can cause death, have happened in people treated with ZYNLONTA®. Tell your healthcare provider right away if you have new or worsening signs or symptoms of infection
  • Skin reactions. Serious skin reactions have happened in people treated with ZYNLONTA®. Tell your healthcare provider if you get new or worsening skin reactions, including sensitivity to sunlight, skin rash, peeling, redness or irritation. You may burn more easily or get severe sunburns

The most common side effects of ZYNLONTA® include:

  • feeling tired or weak
  • skin rash
  • swelling
  • nausea
  • muscle or joint pain
  • increase in blood sugar (hyperglycemia)
  • changes in certain blood or laboratory tests

ZYNLONTA® may cause fertility problems in males which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ZYNLONTA®.

What should I avoid while receiving ZYNLONTA®?

Avoid or limit your exposure to sunlight, including sunlight through glass, such as buildings or vehicle windows and artificial sunlight such as sunlamps or tanning beds. Exposure to sunlight during treatment with ZYNLONTA® can cause skin reaction or rash. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight.

Before you receive ZYNLONTA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have an active infection or have had one recently
  • have liver problems
  • are pregnant or plan to become pregnant. ZYNLONTA® can harm your unborn baby

    Females who can become pregnant:

    • your healthcare provider may do a pregnancy test before starting treatment with ZYNLONTA®
    • you should use effective birth control (contraception) during treatment with ZYNLONTA® and for 10 months after the last dose of ZYNLONTA®. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZYNLONTA®

    Males with female partners who can become pregnant:

    • you should use effective birth control (contraception) during treatment with ZYNLONTA® and for 7 months after the last dose of ZYNLONTA®
  • are breastfeeding or plan to breastfeed. It is not known if ZYNLONTA® passes into breast milk. Do not breastfeed during treatment with ZYNLONTA® and for 3 months after the last dose of ZYNLONTA®

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get new medicine.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to ADC Therapeutics at 1-855-690-0340.

Please see the full Prescribing Information for ZYNLONTA®, including Patient Information, for additional Important Safety Information.

What is ZYNLONTA®?

ZYNLONTA® is a prescription medicine used to treat adults with certain types of large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer.

It is not known if ZYNLONTA® is safe and effective in children.

The approval of ZYNLONTA® is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of ZYNLONTA®.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of ZYNLONTA®?

ZYNLONTA® may cause serious side effects, including:

  • Fluid retention. Your body may hold too much fluid during treatment with ZYNLONTA®. This can be serious. Tell your healthcare provider if you develop new or worsening swelling or puffiness, weight gain, chest pain, shortness of breath, or trouble breathing
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with ZYNLONTA® but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with ZYNLONTA®. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding
  • Read full Important Safety Information
  • Infections. Serious infections, including infections that can cause death, have happened in people treated with ZYNLONTA®. Tell your healthcare provider right away if you have new or worsening signs or symptoms of infection
  • Skin reactions. Serious skin reactions have happened in people treated with ZYNLONTA®. Tell your healthcare provider if you get new or worsening skin reactions, including sensitivity to sunlight, skin rash, peeling, redness or irritation. You may burn more easily or get severe sunburns

The most common side effects of ZYNLONTA® include:

  • feeling tired or weak
  • skin rash
  • swelling
  • nausea
  • muscle or joint pain
  • increase in blood sugar (hyperglycemia)
  • changes in certain blood or laboratory tests

ZYNLONTA® may cause fertility problems in males which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ZYNLONTA®.

What should I avoid while receiving ZYNLONTA®?

Avoid or limit your exposure to sunlight, including sunlight through glass, such as buildings or vehicle windows and artificial sunlight such as sunlamps or tanning beds. Exposure to sunlight during treatment with ZYNLONTA® can cause skin reaction or rash. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight.

Before you receive ZYNLONTA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have an active infection or have had one recently
  • have liver problems
  • are pregnant or plan to become pregnant. ZYNLONTA® can harm your unborn baby

    Females who can become pregnant:

    • your healthcare provider may do a pregnancy test before starting treatment with ZYNLONTA®
    • you should use effective birth control (contraception) during treatment with ZYNLONTA® and for 10 months after the last dose of ZYNLONTA®. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZYNLONTA®

    Males with female partners who can become pregnant:

    • you should use effective birth control (contraception) during treatment with ZYNLONTA® and for 7 months after the last dose of ZYNLONTA®
  • are breastfeeding or plan to breastfeed. It is not known if ZYNLONTA® passes into breast milk. Do not breastfeed during treatment with ZYNLONTA® and for 3 months after the last dose of ZYNLONTA®

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get new medicine.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to ADC Therapeutics at 1-855-690-0340.

Please see the full Prescribing Information for ZYNLONTA®, including Patient Information, for additional Important Safety Information.