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Press Release: Novartis Piqray(R) data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation

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*DJ Novartis Piqray(R) data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation

(MORE TO FOLLOW) Dow Jones Newswires

September 19, 2020 10:25 ET ( 14:25 GMT)



In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant
demonstrated 8 months clinically relevant improvement in overall survival
(OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA
mutation compared to fulvestrant alone1

14+ months OS improvement was achieved in patients with lung or liver
metastases, which are observed in 41% of postmenopausal women with HR+
aBC, and considered more aggressive and challenging to treat1-3

Data add to growing body of evidence for Piqray, the first and only
treatment specifically approved for aBC with a PIK3CA mutation


Basel, September 19, 2020 Novartis today announced results of the
final overall survival (OS) analysis from the SOLAR-1 trial, which
evaluated Piqray(R) (alpelisib) in combination with fulvestrant,
compared to fulvestrant alone, in hormone receptor positive, human
epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast
cancer patients with tumors harboring a PIK3CA mutation. Piqray is the
only treatment approved in Europe, the United States and 15 other
countries specifically for people with HR+/HER2- advanced breast cancer
with a PIK3CA mutation. These data will be presented as a late-breaking
oral presentation during the ESMO Virtual Congress 2020.

In the study, there was a clinically relevant improvement in OS of eight
months for patients with a PIK3CA mutation taking Piqray plus
fulvestrant compared to fulvestrant alone (median OS 39.3 months vs.
31.4 months; one-sided p<=0.0161; HR=0.86; 95% CI: 0.64-1.15; p=0.15)(1)
. This difference did not reach the prespecified threshold of
statistical significance set for the secondary objective of OS in
patients with PIK3CA-mutated breast cancer. A more than 14 month OS
improvement was observed in patients with lung or liver metastases,
which signify more aggressive disease (median OS 37.2 months vs. 22.8
months; HR=0.68; 95% CI: 0.46-1.00)(1-3) .

"These results build on previous data showing that alpelisib nearly
doubled median progression-free survival in this patient population,"
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. "Patients whose tumors have a PIK3CA mutation,
particularly those with lung or liver metastases, have a more aggressive,
harder to treat cancer, so these results showing alpelisib offers longer
life, are promising."

In addition, data showed the need for chemotherapy was delayed in
patients taking Piqray plus fulvestrant by nine months compared to those
taking fulvestrant alone (23.3 months vs. 14.8 months; HR=0.72; 95% CI:
0.54-0.95)(1) . Quality of life (QOL) was maintained for people taking
Piqray plus fulvestrant.

"These data demonstrating survival benefit give the 40% of HR+/HER2-
advanced breast cancer patients with PIK3CA mutations in their tumors
more time to spend with loved ones and do what they value most," said
Susanne Schaffert, PhD, President, Novartis Oncology. "We are committed
to reimagining a world where advanced breast cancer becomes a curable
disease, and these data reinforce our confidence as we continue to
explore the potential use of Piqray in other types of breast cancer with
PIK3CA mutations."

No new safety signals were observed; adverse events were consistent with
previously reported SOLAR-1 results.

Visit https://www.virtualcongress.novartis.com/ESMO20 for the latest
information from Novartis including our bold approach to reimagining
cancer care, and access to our ESMO Virtual Congress 2020 symposia and
data presentations (for registered participants).

In July 2020, the European Commission (EC) approved Piqray in
combination with fulvestrant for the treatment of postmenopausal women,
and men, with HR+/HER2- locally advanced or metastatic breast cancer
with a PIK3CA mutation after disease progression following endocrine
therapy as monotherapy.

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
following progression on or after endocrine-based regimen. Piqray is
approved in 48 countries, including the US and European member states.

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(7-9) .

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(7-9) . 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(7-9) .

About Novartis in Advanced Breast Cancer

Novartis tackles breast cancer with superior science, collaboration and
a passion for transforming patient care. We've taken a bold approach to
our research by including patient populations often neglected in
clinical trials, identifying new pathways or mutations that may play a
role in disease progression and developing therapies that not only
maintain, but also improve, quality of life for patients. Our priority
over the past 30 years and today is to deliver treatments proven to
improve and extend lives for those diagnosed with advanced breast
cancer.

Important Safety Information from the PIQRAY EU SmPC

The most common ADRs and the most common grade 3 / 4 ADRs (reported at a
frequency >20% and >=2%, respectively) were plasma glucose increased,
creatinine increased, gamma-glutamyltransferase increased, rash,
lymphocyte count decreased, nausea, alanine aminotransferase increased,
anaemia, fatigue, lipase increased, decreased appetite*, stomatitis,
vomiting*, weight decreased, hypocalcaemia, plasma glucose decreased*,
activated partial thromboplastin time prolonged*, alopecia**, diarrhoea,
hypokalaemia, hypertension, nausea, creatinine increased, and mucosal
inflammation (*<2% grade 3/4 ADRs reported, ** no grade 3/4 ADRs
reported).

Piqray can cause serious side effects such as severe hypersensitivity,
severe cutaneous reactions, hyperglycaemia, pneumonitis, diarrhoea and
osteonecrosis of the jaw.

The following should be taken into consideration prior to or during
treatment with Piqray:

Piqray should be permanently discontinued in patients with serious
hypersensitivity reactions.

Piqray should not be initiated in patients with a history of severe
cutaneous reactions, should be interrupted if signs or symptoms of
severe cutaneous reactions are present, and permanently discontinued if
a severe cutaneous reaction is confirmed.

Fasting glucose and HbA1c levels should be monitored frequently in the
first 4 weeks of treatment, and patients should be advised of the signs
and symptoms of hyperglycaemia.

In case of new or worsening respiratory symptoms, the patient should be
evaluated for pneumonitis.

Patients should be advised to notify their physician if diarrhoea
occurs.

Caution should be exercised when Piqray and bisphosphonates or denosumab
are used together or sequentially. Piqray should not be initiated in
patients with ongoing osteonecrosis of the jaw.

The efficacy and safety of Piqray has not been studied in patients with
symptomatic visceral disease.

Animal studies suggest that Piqray may cause fetal harm in pregnant
women. Therefore, as a precaution, women of childbearing potential
should use effective contraception while receiving Piqray during
treatment and at least 1 week after stopping treatment. Women should not
breast feed for at least 1 week after the last dose of Piqray. Piqray
may affect fertility in males and females.

Please see full Prescribing Information for Piqray, available at
www.Piqray.com.

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
beliefs and expectations regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those set forth in the forward-looking statements. There can be no

(MORE TO FOLLOW) Dow Jones Newswires

September 19, 2020 10:25 ET ( 14:25 GMT)
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