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For adults with a type of kidney cancer called ccRCC that has spread (advanced) following PD-1 or PD-L1 and VEGF treatments

Clinical trial results for WELIREG

ccRCC = renal cell carcinoma with a clear cell component; PD-1 = programmed death-receptor-1; PD-L1 = programmed death-ligand 1; VEGF = vascular endothelial growth factor.

How WELIREG was studied

A study enrolled 746 adult patients with a type of kidney cancer called renal cell carcinoma with a clear cell component that has spread (advanced ccRCC) following treatment with a PD-1 or PD-L1 and VEGF cancer medicines. In the study, 374 patients took three 40⁠-⁠mg pills of WELIREG once a day compared to 372 patients who took everolimus once a day in order to measure how long patients lived without their cancer getting worse and the length of time a person lived. A closer look at this study is provided below.

Patients

A clinical study including 746 adult patients with advanced ccRCC was conducted.

These patients had received at least two different treatments prior to the study, either used together or one after the other: a PD-1 or PD-L1 and VEGF cancer medicines.

PD-1 = programmed death-receptor-1; PD-L1 = programmed death-ligand 1; VEGF = vascular endothelial growth factor.

Treatment

People in the study were given either three 40-mg pills (120 mg) of WELIREG, a HIF-2α inhibitor, once a day, or one 10-mg pill of an mTOR inhibitor called everolimus once a day.

This continued until the study provider determined it was appropriate to stop treatment due to disease worsening or if people had certain side effects.

HIF-2α = hypoxia-inducible factor 2 alpha; mTOR = mammalian target of rapamycin.

Outcomes

This study measured how long people lived without their cancer getting worse while taking WELIREG compared to everolimus, as well as the length of time a person lived after starting treatment.

It also looked at how many people saw a reduction in tumor size after starting treatment and the duration of response, which measured how long a person responded to treatment.

At the time of patient follow-up:

In this study, WELIREG was proven to reduce the risk of advanced ccRCC spreading, growing, or getting worse by 25% compared to everolimus

Cancer did not progress in 117 out of 374 patients receiving WELIREG compared to 110 out of 372 patients receiving everolimus.

The trial did not show a meaningful difference in how long people who received WELIREG lived compared to how long people who received everolimus lived

  • 32% (120 out of 374) of people treated with WELIREG were alive at the time of patient follow-up
  • 30% (113 out of 372) of people treated with everolimus were alive at the time of patient follow-up

Talk to your doctor to learn more about these clinical trial results.

At the time of patient follow-up:

In a clinical trial, more patients on WELIREG saw their clear cell renal cell tumors shrink than patients on everolimus

100%
0%
22%
4%

82 out of 373 patients

13 out of 364 patients

WELIREG

19% of patients had tumors get smaller (partial response)

3% of patients had tumors disappear (complete response)

everolimus

4% of patients had tumors get smaller (partial response)

0% of patients had tumors disappear (complete response)

Duration of responses

30% (25 out of 82) of patients who responded did not see their cancer get worse for 12 months or longer at the time of patient follow-up.

Learn more about side effects for WELIREG

View side effects

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WELIREG is a prescription medicine used to treat a type of kidney cancer called renal cell carcinoma with a clear cell component in adults that has spread (advanced ccRCC) following treatment with a programmed death-receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) cancer medicines.

It is not known if WELIREG is safe and effective in children with ccRCC.

WELIREG can cause serious side effects. WELIREG can cause harm to your unborn baby.

  • A pregnancy test will be done before you start treatment.
  • Birth control methods that contain hormones may not work as well during treatment.
  • Females and males with female partners who can become pregnant should use an effective form of non-hormonal birth control (contraception) during treatment and for 1 week after your last dose.

WELIREG can cause serious side effects, including:

Low red blood cell counts (anemia). Low red blood cell counts can be severe. You may need a blood transfusion if your red blood cell counts drop too low. Your health care provider will do blood tests to check your red blood cell counts before you start and during treatment with WELIREG. Tell your health care provider if you get any symptoms of low red blood cell counts, including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.

Low oxygen levels in your body. WELIREG can cause low oxygen levels in your body that can be severe and may require you to stop treatment with WELIREG, receive oxygen therapy, or be hospitalized. Your health care provider will monitor your oxygen levels before you start and during treatment with WELIREG. Tell your health care provider or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or increased heart rate.

Harm to your unborn baby. Treatment with WELIREG during pregnancy can cause harm to your unborn baby.

Females who are able to become pregnant:

  • Your health care provider will do a pregnancy test before you start treatment with WELIREG.
  • You should use an effective form of non-hormonal birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with WELIREG.
  • Talk to your health care provider about birth control methods that may be right for you during treatment with WELIREG.
  • Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with WELIREG.

Males with female partners who are able to become pregnant:

  • You should use effective birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Tell your health care provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking WELIREG.

Before taking WELIREG, tell your health care provider about all of your medical conditions, including if you:

  • have low red blood cell counts (anemia)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if WELIREG passes into your breast milk. Do not breastfeed during treatment with WELIREG and for 1 week after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WELIREG with certain other medicines can affect each other and cause serious side effects and may affect the way certain other medicines work.

The most common side effects of WELIREG in adults with VHL disease include:

  • low red blood cell counts
  • tiredness
  • increased blood creatinine (kidney function test)
  • headache
  • dizziness
  • increased blood sugar (glucose) levels
  • nausea

The most common side effects of WELIREG when taken alone in adults with advanced ccRCC include:

  • low red blood cell counts
  • tiredness
  • muscle and joint pain
  • increased blood creatinine (kidney function test)
  • decreased white blood cell counts
  • increased blood liver enzymes (liver function tests)
  • decreased blood salts (sodium) levels
  • increased blood potassium levels

Your health care provider may change your dose, temporarily stop, or permanently stop treatment with WELIREG if you get certain side effects.

WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your health care provider if this is a concern for you.

These are not all of the possible side effects of WELIREG. Call your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for WELIREG, including an important warning about harm to an unborn baby, and discuss it with your doctor. The physician Prescribing Information also is available.

Indication

WELIREG is a prescription medicine used to treat a type of kidney cancer called renal cell carcinoma with a clear cell component in adults that has spread (advanced ccRCC) following treatment with a programmed death-receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) cancer medicines.

It is not known if WELIREG is safe and effective in children with ccRCC.

Important Safety Information

WELIREG can cause serious side effects. WELIREG can cause harm to your unborn baby.

  • A pregnancy test will be done before you start treatment.
  • Birth control methods that contain hormones may not work as well during treatment.
  • Females and males with female partners who can become pregnant should use an effective form of non-hormonal birth control (contraception) during treatment and for 1 week after your last dose.

WELIREG can cause serious side effects, including:

Low red blood cell counts (anemia). Low red blood cell counts can be severe. You may need a blood transfusion if your red blood cell counts drop too low. Your health care provider will do blood tests to check your red blood cell counts before you start and during treatment with WELIREG. Tell your health care provider if you get any symptoms of low red blood cell counts, including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.

Low oxygen levels in your body. WELIREG can cause low oxygen levels in your body that can be severe and may require you to stop treatment with WELIREG, receive oxygen therapy, or be hospitalized. Your health care provider will monitor your oxygen levels before you start and during treatment with WELIREG. Tell your health care provider or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or increased heart rate.

Harm to your unborn baby. Treatment with WELIREG during pregnancy can cause harm to your unborn baby.

Females who are able to become pregnant:

  • Your health care provider will do a pregnancy test before you start treatment with WELIREG.
  • You should use an effective form of non-hormonal birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with WELIREG.
  • Talk to your health care provider about birth control methods that may be right for you during treatment with WELIREG.
  • Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with WELIREG.

Males with female partners who are able to become pregnant:

  • You should use effective birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Tell your health care provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking WELIREG.

Before taking WELIREG, tell your health care provider about all of your medical conditions, including if you:

  • have low red blood cell counts (anemia)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if WELIREG passes into your breast milk. Do not breastfeed during treatment with WELIREG and for 1 week after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WELIREG with certain other medicines can affect each other and cause serious side effects and may affect the way certain other medicines work.

The most common side effects of WELIREG in adults with VHL disease include:

  • low red blood cell counts
  • tiredness
  • increased blood creatinine (kidney function test)
  • headache
  • dizziness
  • increased blood sugar (glucose) levels
  • nausea

The most common side effects of WELIREG when taken alone in adults with advanced ccRCC include:

  • low red blood cell counts
  • tiredness
  • muscle and joint pain
  • increased blood creatinine (kidney function test)
  • decreased white blood cell counts
  • increased blood liver enzymes (liver function tests)
  • decreased blood salts (sodium) levels
  • increased blood potassium levels

Your health care provider may change your dose, temporarily stop, or permanently stop treatment with WELIREG if you get certain side effects.

WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your health care provider if this is a concern for you.

These are not all of the possible side effects of WELIREG. Call your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for WELIREG, including an important warning about harm to an unborn baby, and discuss it with your doctor. The physician Prescribing Information also is available.