Roche announces positive Phase III results for inavolisib
combination in people with advanced hormone receptor-positive,
HER2-negative breast cancer with a PIK3CA mutation
- Phase III (INAVO120)
results show that inavolisib in combination with palbociclib and
fulvestrant significantly improved progression-free survival in the
first-line setting
- PIK3CA
mutations, found in approximately 40% of HR-positive breast
cancers, are linked to tumour growth, disease progression, and
treatment resistance1,2
- Data will be shared with
health authorities and presented at an upcoming medical
meeting
Basel, 5 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today positive results from the Phase III INAVO120 study
of the investigational therapy, inavolisib, in combination with
palbociclib (Ibrance®) and fulvestrant as a potential first-line
treatment option for people with PIK3CA-mutated, hormone receptor
(HR)-positive, HER2-negative, endocrine-resistant, locally advanced
or metastatic breast cancer. The study met its primary endpoint of
progression-free survival (PFS), demonstrating a statistically
significant and clinically meaningful improvement compared to
palbociclib and fulvestrant alone. Overall survival data were
immature at this time, but a clear positive trend has been
observed. Follow-up will continue to the next analysis.
"These pivotal study results for this inavolisib combination
could represent a transformative medical advance for people with
PIK3CA-mutated HR-positive breast cancer," said Levi Garraway,
M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global
Product Development. "We look forward to expanding our portfolio of
breast cancer medicines into the HR-positive space and bringing
this potentially best-in-class new treatment option to patients as
quickly as possible."
The inavolisib combination was well tolerated and adverse events
were consistent with the known safety profiles of the individual
study treatments, with no new safety signals observed.
Inavolisib is an oral therapy with high in vitro potency and
selectivity for PI3Kα inhibition and the ability to specifically
trigger the breakdown of mutant PI3Kα protein. With this unique
dual mechanism of action, inavolisib may provide well-tolerated,
durable disease control and potentially improved outcomes for
people with HR-positive/HER2-negative, PIK3CA-mutated advanced
breast cancer. PIK3CA mutations can lead to mutated PI3Kα protein
which contributes to uncontrolled tumour growth, disease
progression and resistance to endocrine-based treatment.3,4
Inavolisib is currently being investigated in three Phase III
clinical studies in people with PIK3CA-mutated metastatic breast
cancer (INAVO120, INAVO121, INAVO122) in various combinations.
About the INAVO120 study5The
INAVO120 study [NCT04191499] is a Phase III, randomised,
double-blind, placebo-controlled study evaluating the efficacy and
safety of inavolisib in combination with palbociclib and
fulvestrant versus placebo plus palbociclib and fulvestrant in
people with PIK3CA-mutated, hormone receptor (HR)-positive,
HER2-negative, locally advanced or metastatic breast cancer whose
disease progressed during treatment or within 12 months of
completing adjuvant endocrine therapy and who have not received
prior systemic therapy for metastatic disease.
The study included 325 patients, who were randomly assigned to
either the investigational or control treatment arm. The primary
endpoint is progression-free survival, as assessed by
investigators, defined as the time from randomisation in the
clinical trial to the time when the disease progresses, or a
patient dies from any cause. Secondary endpoints include overall
survival, objective response rate, and clinical benefit rate.
About inavolisibInavolisib is an
investigational, oral targeted treatment with best-in-class
potential that could provide well-tolerated, durable disease
control and potentially improved outcomes for people with hormone
receptor (HR)-positive, PIK3CA-mutated breast cancer, a common yet
often overlooked mutation found in approximately 40% of this
population.1 Inavolisib has been designed to help minimise the
overall toxicity of treatment and is differentiated from other PI3K
inhibitors due to its high in vitro potency and specificity for the
PI3K alpha (PI3Kα) isoform inhibition, together with its unique
mechanism of action, that leads to specific degradation of mutant
PI3K alpha.3,4
Inavolisib is currently being investigated in three
Roche-sponsored Phase III clinical studies in PIK3CA-mutated
locally advanced or metastatic breast cancer:
- in combination with palbociclib and
fulvestrant vs. palbociclib and fulvestrant in first-line
HR-positive HER2-negative breast cancer (INAVO120),5
- in combination with fulvestrant vs. alpelisib plus fulvestrant
in HR-positive HER2-negative breast cancer post-CDK4/6 inhibitor
and endocrine combination therapy (INAVO121),6 and
- in combination with pertuzumab plus
trastuzumab for subcutaneous injection (Phesgo®) vs. Phesgo as
maintenance therapy in 1L HER2-positive breast cancer
(INAVO122)7
About hormone receptor-positive breast
cancerHormone receptor (HR)-positive breast cancer is the
most prevalent type of all breast cancers.8 A defining feature of
HR-positive breast cancer is that its tumour cells have receptors
that attach to one or both hormones – estrogen or progesterone –
which can contribute to tumour growth.9 People diagnosed with
HR-positive metastatic breast cancer often face the risk of disease
progression and treatment side effects, creating a need for
additional treatment options.10-12 The PI3K signalling pathway is
commonly dysregulated in HR-positive breast cancer, often due to
activating PIK3CA mutations, which have been identified as a
potential mechanism for resistance to endocrine therapy and CDK4/6
inhibitors.13
About Roche in breast cancerRoche has been
advancing breast cancer research for more than 30 years with the
goal of helping as many people with the disease as possible. Our
medicines, along with companion diagnostic tests, have contributed
to bringing breakthrough outcomes in HER2-positive and
triple-negative breast cancers. As our understanding of breast
cancer biology rapidly improves, we are working to identify new
biomarkers and approaches to treatment for other subtypes of the
disease, including estrogen receptor-positive breast cancer, which
is a form of hormone receptor-positive breast cancer, the most
prevalent type of all breast cancers.
About RocheFounded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] André F, et al. Alpelisib for
PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N
Engl J Med. 2019;380(20):1929-40[2] He Y, et al. Targeting PI3K/Akt
signal transduction for cancer therapy. Signals Transduction and
Targeted Therapy. 2021; 6: 425[3] Juric et al. A phase I/Ib study
of inavolisib (GDC-0077) in combination with fulvestrant in
patients (pts) with PIK3CA-mutated hormone
receptor-positive/HER2-negative (HR+/HER2–) metastatic breast
cancer. Presented at San Antonio Breast Cancer Symposium, 2020
December 7-10; San Antonio, USA. Abstract #P5-17-05[4] Hong R., et
al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates
robust efficacy in PIK3CA mutant breast cancer models as a single
agent and in combination with standard of care therapies. Cancer
Res. 2018;78(4):4-14.
https://doi.org/10.1158/1538-7445.SABCS17-PD4-14[5]
ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of
Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib +
Fulvestrant in Patients With PIK3CA-Mutant, Hormone
Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic
Breast Cancer (INAVO120) [Internet; cited 2023 December] Available
from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499[6]
ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of
Inavolisib Plus Fulvestrant Compared With Alpelisib Plus
Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA
Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i
and Endocrine Combination Therapy (INAVO121) [Internet; cited 2023
December] Available from:
https://classic.clinicaltrials.gov/ct2/show/NCT05646862[7]
ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of
Inavolisib in Combination With Phesgo Versus Placebo in Combination
With Phesgo in Participants With PIK3CA-Mutated HER2-Positive
Locally Advanced or Metastatic Breast Cancer [Internet; cited 2023
December] Available from:
https://clinicaltrials.gov/study/NCT05894239?term=WO44263&rank=1[8]
National Cancer Institute: Surveillance, Epidemiology and Ends
Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes.
[Internet; cited 2023 December] Available from:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html[9] Lim
E., et al. The natural history of hormone receptor-positive breast
cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[10]
Galipeau N., et al. Understanding key symptoms, side effects, and
impacts of HR+/HER- advanced breast cancer: qualitative study
findings. J Patient-Rep Outcomes. 2019;3(1):10. doi:
10.1186/s41687-019-0098-1[11] Buonomoa B. and Peccatori FA.
Fertility preservation in endocrine responsive breast cancer: data
and prejudices. ecancer. 2020;14:1157. doi:
10.3332/ecancer.2020.1157[12] Tomas R. and Barrios CH. Optimal
management of hormone receptor positive metastatic breast cancer in
2016. Ther Adv Med Oncol. 2015;7(6):304-20. doi:
10.1177/1758834015608993[13] Schwartzberg LS. and Vidal GA.
Targeting PIK3CA Alterations in Hormone Receptor-Positive, Human
Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer:
New Therapeutic Approaches and Practical Considerations. Clin
Breast Cancer. 2020;20(4):e439-e449. doi:
10.1016/j.clbc.2020.02.002
Roche Global Media RelationsPhone: +41 61 688
8888 / e-mail: media.relations@roche.com
Hans Trees, PhDPhone: +41 79 407
72 58 |
Nathalie
AltermattPhone: +41 79 771 05 25 |
Simon
GoldsboroughPhone: +44 797 32 72 915 |
Karsten
KleinePhone: +41 79 461 86 83 |
Nina
MählitzPhone: +41 79 327 54 74 |
Kirti
PandeyPhone: +49 172 6367262 |
Dr.
Rebekka SchnellPhone: +41 79 205 27 03 |
Sileia
UrechPhone: +41 79 935 81 48 |
Roche Investor Relations
Dr. Bruno
Eschli Phone: +41 61 68-75284 e-mail:
bruno.eschli@roche.com |
Dr.
Sabine BorngräberPhone: +41 61 68-88027 e-mail:
sabine.borngraeber@roche.com |
Dr.
Birgit MasjostPhone: +41 61 68-84814e-mail:
birgit.masjost@roche.com |
Dr.
Gerard Tobin Phone: +41 61 68-72942 e-mail:
gerard.tobin@roche.com |
Investor Relations North America
Loren
KalmPhone: +1 650 225 3217 e-mail:
kalm.loren@gene.com |
- 05122023_MR_Phase III results for inavolisib_en
Roche (LSE:0QQ6)
Historical Stock Chart
From May 2024 to Jun 2024
Roche (LSE:0QQ6)
Historical Stock Chart
From Jun 2023 to Jun 2024