EAST HANOVER, N.J.,
Dec. 10, 2021 /PRNewswire/ --
Novartis today announced new Piqray® (alpelisib) data
indicating benefit across a broad range of patient and disease
characteristics as seen in analyses from all three cohorts of
BYLieve. BYLieve is an ongoing Phase II, open-label, 3-cohort
non-comparative study evaluating Piqray with endocrine therapy
including men and pre- and postmenopausal women with
hormone-receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) advanced or metastatic breast cancer (mBC) who
have progressed on or after prior therapies, including CDK4/6
inhibitor plus endocrine therapy1-5. These data will be
presented at the 2021 San Antonio Breast Cancer Symposium (SABCS)
from December 7-10.
"The data from all three cohorts of the BYLieve study have value
for the medical community and for the patients we care for with
mBC, because these cohorts show a benefit from alpelisib in the
post-CDK4/6i setting for patients with HR+/HER2- PIK3CA-mutated
cancer," said Dr. Hope S. Rugo,
Director, Breast Oncology and Clinical Trials Education,
University of California San Francisco
(UCSF) Helen Diller Family Comprehensive Cancer Center. "Beyond
illustrating the efficacy and safety of alpelisib, regardless of
the duration of prior CDK4/6i treatment, the data provide
meaningful insights into how alpelisib may benefit different
subgroups of patients."
Highlights from the BYLieve data presented at SABCS
- BYLieve Cohort A (P1-18-03): Updated safety and
efficacy data after 18 months of follow-up showed median overall
survival improvement of 26.4 months (95% CI: 21.0-30.5) for
patients treated with Piqray plus fulvestrant immediately following
CDK4/6i plus an AI1. The most common all-grade adverse
events (AEs) (n=127) were diarrhea (63.8%), hyperglycemia (59.8%),
nausea (46.5%) and rash (31.5%)1.
- BYLieve Cohort C (PD13-05): The third and final
BYLieve cohort included patients who received chemotherapy or
endocrine therapy as immediate prior treatment, who could have
received prior CDK4/6i as well2.
-
- The primary endpoint was met with 48.7% (95% CI: 39.3%-58.2%)
of patients alive and without disease progression at six
months2.
- Data confirm clinically relevant activity of Piqray as a
targeted therapy for PIK3CA as a driver oncogene2.
- No new safety signals were observed, with the most common
all-grade AEs (n=126) being hyperglycemia (65.1%), diarrhea
(52.4%), nausea (40.5%) and rash (38.9%)2.
- BYLieve Cohorts A & B (P1-18-08; P5-13-03;
PD15-01): Exploratory biomarker and post-hoc analyses
demonstrated efficacy with Piqray plus fulvestrant/letrozole in
CDK4/6i-resistant mBC, as seen in patients with early
discontinuation of the prior CDK4/6i (Cohort A: ≤6 months median
PFS of 12.0 months and >6 months median PFS of 6.2 months;
HR=0.51; 95% CI: 0.29-0.89; Cohort B: ≤6 months median PFS of 5.9
months and >6 months median PFS of 5.6 months; HR=0.72; 95% CI:
0.45-1.18), supporting the use of Piqray plus endocrine therapy as
an immediate next-line option in these patients3. Grade
≥3 AEs were experienced by 84.6% (n=22) and 66.0% (n=66) of
patients in the ≤6 months and >6 months subgroups, respectively,
in Cohort A and by 62.5% (n=20) and 72.5% (n=66) of patients in the
≤6 months and >6 months subgroups, respectively, in Cohort
B3.
Additionally, the exploratory ctDNA analysis from Cohorts A and
B (median PFS of 7.3 months and 5.7 months in Cohorts A and Cohort
B, respectively) found that Piqray was effective in the
post-CDK4/6i setting regardless of endocrine therapy partner and
tumor genomic profile and other mutations associated with CDK4/6i
resistance4. Across the three cohorts no new safety
signals were observed, even with longer exposure, as seen in Cohort
A, confirming no cumulative toxicities with
Piqray1-3.
An estimated 361,826 people are diagnosed with mBC worldwide
each year, and approximately 40% of those with HR+/HER2- subtype
have a PIK3CA mutation, which is associated with a poor
prognosis8-9.
Visit https://www.hcp.novartis.com/virtual-congress/sabcs-2021/
for the latest information from Novartis, including our commitment
to the Oncology community, and access to our SABCS Virtual
Scientific Program data presentations (for registered
participants).
About Piqray® (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 regimen7. Piqray
is approved in 64 countries, including the US and European member
states12.
Novartis is continuing to reimagine cancer with additional
trials of Piqray. EPIK-B5 will be a large Phase III clinical trial
of Piqray in combination with fulvestrant to complement the SOLAR-1
study13. Novartis is also studying the potential of
Piqray in triple negative breast cancer (TNBC) in the EPIK-B3 Phase
III clinical trial, in advanced HER2+ breast cancer in the EPIK-B2
Phase III clinical trial and in ovarian cancer in the EPIK-O Phase
III clinical trial14-16.
Indication
PIQRAY® (alpelisib) tablets is
a prescription medicine used in combination with the medicine
fulvestrant to treat women who have gone through menopause and men
who have hormone receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative advanced breast cancer or breast
cancer that has spread to other parts of the body (metastatic),
with an abnormal phosphatidylinositol-3-kinase catalytic subunit
alpha (PIK3CA) gene, and whose disease has progressed on or after
endocrine therapy. Your health care provider will test your cancer
for an abnormal "PIK3CA" gene to make sure that PIQRAY is right for
you. It is not known if PIQRAY is safe and effective in
children.
Important Safety 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 its complications 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 or
its complications, 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. 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 Prescribing Information for PIQRAY, available at
www.piqray.com.
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.
Disclaimer
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"could," "would," "expect," "anticipate," "look forward,"
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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 guarantee that the investigational or approved
products described in this press release will be submitted or
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About Novartis
Located in East Hanover, NJ
Novartis Pharmaceuticals Corporation – an affiliate of Novartis –
is reimagining medicine to improve and extend people's lives. As a
leading global medicines company, we use innovative science and
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References
- Ciruelos EM et al. Alpelisib + fulvestrant in patients with
hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-), PIK3CA-mutated advanced breast cancer
(ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i) + aromatase inhibitor (AI): 18-month follow-up of BYLieve
Cohort A. Presented at the San Antonio Breast Cancer Symposium,
December 8, 2021. Abstract
#P1-18-03.
- Rugo HS et al. Alpelisib + fulvestrant in patients with
PIK3CA-mutated, HR+, HER2- advanced breast cancer (ABC) who
received chemotherapy or endocrine therapy (ET) as immediate prior
treatment: BYLieve Cohort C primary results and exploratory
biomarker analyses. Presented at the San Antonio Breast Cancer
Symposium, December 10, 2021.
Abstract #PD13-05.
- Chia S et al. Effect of duration of prior cyclin-dependent
kinase 4/6 inhibitor (CDK4/6i) therapy (≤6 mo or >6 mo) on
alpelisib benefit in patients with hormone receptor-positive (HR+),
human epidermal growth factor receptor 2-negative (HER2-),
PIK3CA-mutated advanced breast cancer (ABC) from BYLieve. Presented
at the San Antonio Breast Cancer Symposium, December 8, 2021. Abstract # P1-18-08.
- Juric D et al. Alpelisib + endocrine therapy (ET) in patients
with hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-), PIK3CA-mutated advanced breast cancer
(ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i): Biomarker analyses from the Phase II BYLieve study.
Presented at the San Antonio Breast Cancer Symposium, December 8, 2021. Abstract #P5-13-03.
- Turner N et al. Impact of ESR1 mutations on endocrine therapy
(ET) plus alpelisib benefit in patients with hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-), PIK3CA-mutated, advanced breast cancer (ABC)
who progressed on or after prior cyclin-dependent kinase inhibitor
(CDK4/6i) therapy in the BYLieve trial. Presented at the San
Antonio Breast Cancer Symposium, December
10, 2021. Abstract #PD15-01.
- Burstein HJ, Somerfield MR, Barton
DL, et al: Endocrine treatment and targeted therapy for
HR-positive, HER2-negative metastatic breast Cancer: ASCO Guideline
update. J Clin Oncol. July 29,
2021.
- Piqray (alpelisib) Prescribing Information. East Hanover, New Jersey, USA: Novartis
Pharmaceuticals Corporation; July
2021.
- The Cancer Genome Atlas Network. Comprehensive molecular
portraits of human breast tumours. Nature.
2012;490(7418):61-70.
- Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular
landscape of patients with PIK3CA-mutated metastatic breast cancer.
Ann Oncol. 2020;31(3):377-386.
- Fribbens, C., et al. Tracking Evolution of Aromatase Inhibitor
Resistance with Circulating Tumour DNA Analysis in Metastatic
Breast Cancer. Ann Oncol. 2018;29(1):145-153.
https://doi.org/10.1093/annonc/mdx483.
- Dustin D, et al. ESR1 Mutations in Breast Cancer.
Cancer. 2019;125(21):3714-3728,
https://doi.org/10.1002/cncr.32345.
- Novartis Data on File. Novartis Pharmaceuticals Corp:
2021.
- Novartis Pharmaceuticals. Study to Assess the Efficacy and
Safety of Alpelisib Plus Fulvestrant in Participants With
HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After
Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor:
EPIK-B5 (October 27, 2021-
November 27, 2026). Identifier:
NCT05038735.
https://www.clinicaltrials.gov/ct2/show/NCT05038735.
- Novartis Pharmaceuticals. Study Assessing the Efficacy and
Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC
Who Carry Either a PIK3CA Mutation or Have PTEN Loss: EPIK-B3
(June 8, 2020-January 9, 2026). Identifier: NCT04251533.
https://www.clinicaltrials.gov/ct2/show/NCT04251533.
- Novartis Pharmaceuticals. EPIK-B2: A Two Part, Phase III,
Multicenter, Randomized (1:1), Double-blind, Placebo-controlled
Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in
Combination With Trastuzumab and Pertuzumab as Maintenance Therapy
in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA
Mutation. Identifier: NCT04208178.
https://www.clinicaltrials.gov/ct2/show/ NCT04208178.
- Novartis Pharmaceuticals. Alpelisib Plus Olaparib in
Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer,
With no Germline BRCA Mutation Detected: EPIK-O (July 2, 2021-January 31,
2025). Identifier: NCT04729387.
https://www.clinicaltrials.gov/ct2/show/NCT04729387.
###
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