How ZYNYZ was studied

ZYNYZ is an FDA-approved treatment studied in combination with chemotherapy for people with squamous cell carcinoma of the anal canal (SCAC)

In the POD1UM-303 trial, ZYNYZ was studied in 308 people with SCAC. ZYNYZ was given in combination with the chemotherapy medicines carboplatin and paclitaxel to people whose cancer had returned and could not be removed by surgery or had spread.

  • People could not take part in the trial if their immune system function was changed by medicines they were receiving (called immunosuppressants) or by an active autoimmune disease
  • People who were HIV-positive could take part in the trial if they had an undetectable viral load, an appropriate CD4+ count, and were receiving appropriate treatment

About the POD1UM-303 clinical trial

There were 2 groups of people included in the trial. Group 1 received ZYNYZ, while Group 2 received a treatment with no active ingredient, called a placebo. Both groups received the chemotherapy medicines carboplatin and paclitaxel.

Group 1
154 PEOPLE RECEIVED ZYNYZ + CHEMOTHERAPY
People icon showing how many patients were in the clinical trial
People icon showing how many patients were in the clinical trial
Group 2
154 PEOPLE RECEIVED PLACEBO + CHEMOTHERAPY
People icon showing how many patients were in the clinical trial
People icon showing how many patients were in the clinical trial

People in Group 2 could switch to Group 1 if their SCAC got worse.

Small calendar icon showing people stayed on ZYNYZ up to 12 months or progression

People in the trial stayed on chemotherapy for up to 6 months. Patients stayed on ZYNYZ for up to
12 months, or until it stopped working or they experienced serious side effects

ZYNYZ + chemotherapy gave people with SCAC a chance for more time

MEDIAN PROGRESSION-FREE SURVIVAL

Median progression-free survival is the length of time that half of the people in a treatment group went without their disease getting worse (disease progression) or death.

ZYNYZ + chemotherapy reduced the risk of disease progression or death by 37%, giving patients a longer period of time during which their tumor did not grow or spread compared to those who received placebo + chemotherapy.

Calendar icons showing progression-free survival data
Calendar icons showing progression-free survival data
MEDIAN OVERALL SURVIVAL

Median overall survival is the time from when people started the trial to the time at which half of the people in a treatment group were still alive.

Median overall survival in the ZYNYZ + chemotherapy group was 6 months longer compared to the placebo + chemotherapy group.

Calendar icons showing overall survival data
Calendar icons showing overall survival data

This is an interim analysis, meaning that the trial is still ongoing and these results are not conclusive.

More people responded to ZYNYZ and had responses lasting twice as long than with chemotherapy alone

OVERALL RESPONSE RATE

Overall response rate is the percentage of people who had their tumors disappear* (complete response) or shrink in size by a certain amount (partial response) during treatment.

ZYNYZ + chemotherapy was effective in more than half of the people in the trial.

Iconography showing ZYNYZ was effective in more than half of people in study, and complete and partial response rates
ZYNYZ + CHEMOTHERAPY graphic
PLACEBO + CHEMOTHERAPY graphic

These results were based on a clinical trial, and the effects of treatment may be different for everyone.

*Disappearance of all signs of cancer in response to treatment does not always mean the cancer has been cured.

MEDIAN DURATION OF RESPONSE

Median duration of response (DOR) is the length of time that half of the people continued to be in response. This means they were living without their cancer growing or spreading.

People who received ZYNYZ + chemotherapy had responses that lasted approximately 2 times as long as those for people who received placebo + chemotherapy: 14 months vs 7.2 months (median).

Shape icons highlight 14 months v 7.2 month DOR
Shape icons highlight 14 months v 7.2 month DOR

In the POD1UM-202 trial, ZYNYZ was studied in 94 people diagnosed with SCAC. These people had anal cancer that had returned or spread and received platinum-based chemotherapy and it did not work, was no longer working, or they could not tolerate it. All the people in the trial received treatment with ZYNYZ.

IV bag icon

People were able to enroll in the trial if they had received chemotherapy that contained platinum, and it did not work, was no longer working, or they could not tolerate it.

Shield with a plus sign on it

People could not take part in the trial if their immune system function was changed by medicines they were receiving (called immunosuppressants) or by an active autoimmune disease.

Checkmark icon

People who were HIV-positive could take part in the trial if they had an undetectable viral load, an appropriate CD4+ count, and were receiving appropriate treatment.

ZYNYZ helped some people achieve lasting results
OVERALL RESPONSE RATE

Overall response rate is the percentage of people who had their tumors disappear* (complete response) or shrink in size by a certain amount (partial response) during treatment with ZYNYZ.

ZYNYZ was effective in 14% of people in the trial.

Iconography showing overall response rate, complete response rate, and partial response rate of ZYNYZ as a monotherapy
Iconography showing overall response rate, complete response rate, and partial response rate of ZYNYZ as a monotherapy

These results were based on a clinical trial, and the effects of treatment may be different for everyone.

*Disappearance of all signs of cancer in response to treatment does not always mean the cancer has been cured.

DURATION OF RESPONSE

Duration of response is how long people’s response to treatment with ZYNYZ lasted. The median duration of response (the length of time that half of the people continued to be in response) to ZYNYZ was 9.5 months, and people’s responses ranged from:

Calendar icon showing duration of response
What to expect during treatment with ZYNYZ

Dosing and Administration

What is ZYNYZ?

ZYNYZ is a prescription medicine used to treat adults with:

  • a type of anal cancer called squamous cell carcinoma of the anal canal (SCAC).
    • ZYNYZ may be used in combination with the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your anal cancer:
      • has returned and cannot be removed by surgery, or
      • has spread.
    • ZYNYZ may be used alone when your anal cancer:
      • has returned or has spread and
      • you have received chemotherapy that contains platinum, and it did not work, is no longer working, or you could not tolerate it.

It is not known if ZYNYZ is safe and effective in children.

Important Safety Information

What is the most important information I should know about ZYNYZ?

ZYNYZ is a medicine that may treat certain types of cancers by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment with ZYNYZ. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment with ZYNYZ if you have severe side effects.

Before you receive ZYNYZ, tell your doctor about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ or tissue transplant, including corneal transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby.

Females who are able to become pregnant:

  • Your doctor should do a pregnancy test before you start treatment with ZYNYZ.
  • You should use an effective method of birth control during your treatment and for 4 months after your last dose of ZYNYZ. Talk to your doctor about birth control methods that you can use during this time.
  • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ZYNYZ.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ZYNYZ.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZYNYZ when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness; numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of ZYNYZ when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

These are not all the possible side effects of ZYNYZ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ZYNYZ

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your doctor. You can ask your doctor for information about ZYNYZ that is written for health professionals.

Please see the Full Prescribing Information, including the Medication Guide, for ZYNYZ.

 
 

What is ZYNYZ?

ZYNYZ is a prescription medicine used to treat adults with:

  • a type of anal cancer called squamous cell carcinoma of the anal canal (SCAC).
    • ZYNYZ may be used in combination with the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your anal cancer:
      • has returned and cannot be removed by surgery, or
      • has spread.
    • ZYNYZ may be used alone when your anal cancer:
      • has returned or has spread and
      • you have received chemotherapy that contains platinum, and it did not work, is no longer working, or you could not tolerate it.

It is not known if ZYNYZ is safe and effective in children.

Important Safety Information

What is the most important information I should know about ZYNYZ?

ZYNYZ is a medicine that may treat certain types of cancers by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment with ZYNYZ. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment with ZYNYZ if you have severe side effects.

Before you receive ZYNYZ, tell your doctor about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ or tissue transplant, including corneal transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby.

Females who are able to become pregnant:

  • Your doctor should do a pregnancy test before you start treatment with ZYNYZ.
  • You should use an effective method of birth control during your treatment and for 4 months after your last dose of ZYNYZ. Talk to your doctor about birth control methods that you can use during this time.
  • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ZYNYZ.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ZYNYZ.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZYNYZ when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness; numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of ZYNYZ when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

These are not all the possible side effects of ZYNYZ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ZYNYZ

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your doctor. You can ask your doctor for information about ZYNYZ that is written for health professionals.

Please see the Full Prescribing Information, including the Medication Guide, for ZYNYZ.