Press Release: Novartis Piqray(R) receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

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-- Piqray (alpelisib) in combination with fulvestrant will become first and

only targeted treatment for advanced breast cancer patients whose tumors

harbor a PIK3CA mutation in Europe

-- Phase III trial showed Piqray plus fulvestrant nearly doubled median PFS

(11.0 vs. 5.7 months) in this patient population, compared to fulvestrant

alone

-- PIK3CA mutations affect approximately 40% of HR+/HER2- advanced breast

cancer patients and are linked to cancer growth and a poorer disease

prognosis in the metastatic setting

The digital press release with multimedia content can be accessed here:

https://novartis.gcs-web.com/Novartis-Piqray-receives-positive-CHMP-opinion-to-treat-HR-HER2-advanced-breast-cancer-with-a-PIK3CA-mutation

Basel, May 29, 2020 -- Novartis today announced the Committee for

Medicinal Products for Human Use (CHMP) of the European Medicines Agency

has adopted a positive opinion recommending approval of Piqray(R)

(alpelisib) in combination with fulvestrant for the treatment of

postmenopausal women, and men, with hormone receptor positive, human

epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced

or metastatic breast cancer with a PIK3CA mutation after disease

progression following endocrine therapy as monotherapy.

"PIK3CA is the most commonly mutated gene in HR+/HER2- advanced breast

cancer, affecting approximately 40% of patients. If approved, alpelisib

has the potential to transform the way we treat this cancer in Europe,

offering physicians a clear treatment for patients with a PIK3CA

mutation that nearly doubles the time to disease progression," said

Fabrice André, MD, PhD, research director and head of INSERM Unit

U981, professor in the Department of Medical Oncology at Institut

Gustave Roussy in Villejuif, France, and global SOLAR-1 principal

investigator.

The CHMP opinion is based on results of the Phase III SOLAR-1 trial that

showed Piqray plus fulvestrant nearly doubled median progression-free

survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced

breast cancer patients with tumors harboring a PIK3CA mutation (median

PFS 11.0 months vs. 5.7 months; HR=0.65, 95% CI: 0.50-0.85; p<0.001),

the study's primary endpoint. PFS subgroup analyses demonstrated

consistent efficacy in favor of Piqray, irrespective of presence or

absence of lung/liver metastases.

"We are excited about today's CHMP opinion, recommending the first and

only treatment option for European patients specifically developed to

target the PIK3CA mutation in their cancer," said Susanne Schaffert, PhD,

President, Novartis Oncology. "Piqray is another example of how we are

reimagining cancer care to bring new targeted therapies to patients with

high unmet needs that help them live longer without disease

progression."

In SOLAR-1, most adverse events were mild to moderate in severity and

generally manageable through dose modifications and medical management.

Of these, the most common grade 3/4 events (>=7%) were plasma glucose

increased (39.1%), rash (19.4%), gamma-glutamyltransferase increased

(12.0%), lymphocyte count decreased (9.2%), diarrhea (7.0%) and lipase

increased (7.0%). No patients developed diabetes as a result of

transient hyperglycemia.

The European Commission will review the CHMP recommendation and usually

delivers a final decision within approximately two months. The decision

will be applicable to all 27 European Union member states plus the

United Kingdom, Iceland, Norway and Liechtenstein. Additional regulatory

filings are underway with other health authorities worldwide.

Patients with HR+/HER2- advanced breast cancer should be selected for

treatment with Piqray based on the presence of a PIK3CA mutation in

tumor or plasma specimens, using a validated test. If a mutation is not

detected in a plasma specimen, tumor tissue should be tested if

available.

About Piqray(R) (alpelisib)

Piqray is a kinase inhibitor developed for use in combination with

fulvestrant for the treatment of postmenopausal women, and men, with

HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer, as

detected by a validated test following progression on or after

endocrine-based regimen. Piqray is approved in the U.S., and 12 other

countries around the world.

About SOLAR-1

SOLAR-1 is a global, Phase III randomized, double-blind,

placebo-controlled trial studying Piqray in combination with fulvestrant

for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2-

advanced or metastatic breast cancer that progressed on or following

aromatase inhibitor treatment with or without a CDK4/6 inhibitor(1,2,3)

.

The trial randomized 572 patients. Patients were allocated based on

central tumor tissue assessment to either a PIK3CA-mutated cohort

(n=341) or a PIK3CA non-mutated cohort (n=231). Within each cohort,

patients were randomized in a 1:1 ratio to receive continuous oral

treatment with Piqray (300 mg once daily) plus fulvestrant (500 mg every

28 days + Cycle 1 Day 15) or placebo plus fulvestrant. Stratification

was based on visceral metastases and prior CDK4/6 inhibitor

treatment(1,2,3). Patients and investigators are blinded to PIK3CA

mutation status and treatment.

The primary endpoint is local investigator assessed PFS using RECIST 1.1

for patients with a PIK3CA mutation. The key secondary endpoint is

overall survival, and additional secondary endpoints include, but are

not limited to, overall response rate, clinical benefit rate,

health-related quality of life, efficacy in PIK3CA non-mutated cohort,

safety and tolerability(1,2,3). SOLAR-1 is ongoing to assess overall

survival and other secondary endpoints.

Piqray(R) (alpelisib) Important Safety Information from the U.S.

Prescribing Information

Patients should not take PIQRAY if they have had a severe allergic

reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.

PIQRAY may cause serious side effects. PIQRAY can cause severe allergic

reactions. Patients should tell their health care provider or get

medical help right away if they have trouble breathing, flushing, rash,

fever, or fast heart rate during treatment with PIQRAY. PIQRAY can cause

severe skin reactions. Patients should tell their health care provider

or get medical help right away if they 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. PIQRAY can cause high blood sugar levels (hyperglycemia).

Hyperglycemia is common with PIQRAY and can be severe. Health care

providers will monitor patients' blood sugar levels before they start

and during treatment with PIQRAY. Health care providers may monitor

patients' blood sugar levels more often if they have a history of Type 2

diabetes. Patients should tell their health care provider right away if

they develop symptoms of hyperglycemia, including excessive thirst, dry

mouth, urinate more often than usual or have a higher amount of urine

than normal, or increased appetite with weight loss. PIQRAY can cause

lung problems (pneumonitis). Patients should tell their health care

provider right away if they develop new or worsening symptoms of lung

problems, including shortness of breath or trouble breathing, cough, or

chest pain. Diarrhea is common with PIQRAY and can be severe. Severe

diarrhea can lead to the loss of too much body water (dehydration) and

kidney problems. Patients who develop diarrhea during treatment with

PIQRAY should tell their health care provider right away.

Before taking PIQRAY, patients should tell their health care provider if

they have a history of diabetes, skin rash, redness of skin, blistering

of the lips, eyes or mouth, or skin peeling, are pregnant, or plan to

become pregnant as PIQRAY can harm their unborn baby. Females who are

able to become pregnant should use effective birth control during

treatment with PIQRAY and for 1 week after the last dose. Do not

breastfeed during treatment with PIQRAY and for 1 week after the last

dose. 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. Patients should also read the Full

Prescribing Information of fulvestrant for important pregnancy,

contraception, infertility, and lactation information.

Patients should tell their health care provider all of the medicines

they 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 are

rash, nausea, tiredness and weakness, decreased appetite, mouth sores,

vomiting, weight loss, hair loss, and changes in certain blood tests.

Please see full U.S. Prescribing Information for Piqray, available at

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/piqray.pdf.

Disclaimer

This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

such as "potential," "can," "will," "plan," "may," "could," "would,"

"expect," "anticipate," "seek," "look forward," "believe," "committed,"

"investigational," "pipeline," "launch," or similar terms, or by express

or implied discussions regarding potential marketing approvals, new

indications or labeling for the investigational or approved products

described in this press release, or regarding potential future revenues

from such products. You should not place undue reliance on these

statements. Such forward-looking statements are based on our current

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May 29, 2020 06:45 ET (10:45 GMT)