Clinical Trial Results | PIQRAY® (alpelisib) tablets

Considering PIQRAY?

Our patient brochure is a comprehensive resource to help you start a conversation with your doctor.

Picture of potential patient. Results with PIQRAY

What is PIQRAY used to treat?

PIK3CA mutations have been linked to cancer growth. But together, PIQRAY and fulvestrant is a treatment that can help slow the progression of HR+, HER2- metastatic breast cancer (mBC) with a PIK3CA mutation.

PIQRAY was studied in a clinical trial that included 572 postmenopausal women and men, with HR+, HER2- metastatic breast cancer (mBC) who had progressed on or after an aromatase inhibitor (a hormone therapy). Of the 341 people who tested positive for the PIK3CA mutation, 169 took PIQRAY + fulvestrant (hormone therapy), while 172 took fulvestrant alone.

How can PIQRAY help?

More time without disease progression.

People who tested positive for a PIK3CA mutation and took PIQRAY + fulvestrant lived progression-free for almost twice as long as those who took fulvestrant alone.

Median time people with PIK3CA mutation were progression-free from the start of treatment

Median time people with a PIK3CA mutation were progression free from the start of treatment

PIQRAY shrank tumors in more than twice as many people with a PIK3CA mutation in the clinical trial

Additional results of the trial showed that PIQRAY and fulvestrant worked together to shrink tumors in people with a PIK3CA mutation who had tumors large enough to measure. Of the 262 people with measurable disease, 126 took PIQRAY + fulvestrant and 136 took fulvestrant alone.

Twice as many people with a PIK3CA mutation who had tumors large enough to measure who took PIQRAY + fulvestrant had tumors that shrank or disappeared vs those who took fulvestrant alone.

*34.9% of people with a PIK3CA mutation who had tumors large enough to measure who took PIQRAY + fulvestrant saw their tumors shrink in size vs 14.7% of those who took fulvestrant without PIQRAY. And 0.8% of people with a PIK3CA mutation who had tumors large enough to measure who took PIQRAY + fulvestrant had their tumors completely disappear vs 1.5% of those who took fulvestrant without PIQRAY.

Next: Talking With Your Doctor About PIQRAY →

Tap to see IMPORTANT SAFETY INFORMATION AND APPROVED USE

Important Safety Information

Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.

PIQRAY may cause serious side effects, including:

Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY...

Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.

PIQRAY may cause serious side effects, including:

Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY
Severe skin reactions: Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever
High blood sugar levels (hyperglycemia): Hyperglycemia is common with PIQRAY and may be severe. Your health care provider will monitor your blood sugar levels before you start and during treatment with PIQRAY. Your health care provider may monitor your blood sugar levels more often if you have a history of type 2 diabetes. Tell your health care provider right away if you develop symptoms of hyperglycemia, including excessive thirst, dry mouth, urinating more often than usual or having a higher amount of urine than normal, increased appetite with weight loss, confusion, nausea, vomiting, fruity odor on breath, difficulty breathing, or dry or flushed skin
Lung problems (pneumonitis): Tell your health care provider right away if you develop new or worsening symptoms of lung problems, including shortness of breath or trouble breathing, cough, or chest pain
Diarrhea or colitis (inflammation of your intestines): Diarrhea is common with PIQRAY and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your health care provider right away, if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with PIQRAY. Your health care provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis

Your health care provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with PIQRAY if you get certain serious side effects.

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

have a history of diabetes
have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling
are pregnant or plan to become pregnant. PIQRAY can harm your unborn baby

Females who are able to become pregnant:

Your health care provider will check to see if you are pregnant before you start treatment with PIQRAY
You should use effective birth control during treatment with PIQRAY and for 1 week after the last dose. Talk to your health care provider about birth control methods that may be right for you during this time
If you become pregnant or think you are pregnant, tell your health care provider right away

Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with PIQRAY and for 1 week after the last dose. If your female partner becomes pregnant, tell your health care provider right away.

are breastfeeding or plan to breastfeed. It is not known if PIQRAY passes into your breast milk. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose

You should also read the full Prescribing Information of fulvestrant for important pregnancy, contraception, infertility, and lactation information.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

The most common side effects of PIQRAY when used with fulvestrant include:

rash
nausea
tiredness and weakness
decreased appetite
mouth sores
vomiting
weight loss
hair loss
changes in certain blood tests

PIQRAY may affect fertility in males and in females who are able to become pregnant. Talk to your health care provider if this is a concern for you.

These are not all the possible side effects of PIQRAY. Call your doctor 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 see full Prescribing Information, including Patient Information. ↗

6/23 274262