Roche’s inavolisib combination reduces the risk of disease
progression by 57% in people with advanced hormone
receptor-positive, HER2-negative breast cancer with a PIK3CA
mutation
- Inavolisib in combination
with palbociclib and fulvestrant more than doubled progression-free
survival compared to palbociclib and fulvestrant
alone1
- The inavolisib combination
has the potential to address resistance to treatment and poor
prognosis associated with PIK3CA
mutations2-5
- These new data are being
presented today in an oral presentation at the 2023 San Antonio
Breast Cancer Symposium and shared with health
authorities
Basel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
presented today positive results from the Phase III INAVO120 study
evaluating inavolisib in combination with palbociclib (Ibrance®)
and fulvestrant as a first-line treatment for people with
PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative,
endocrine-resistant, locally advanced or metastatic breast
cancer.1
The inavolisib combination reduced the risk of disease worsening
or death (progression-free survival; PFS) by 57% compared to
palbociclib and fulvestrant alone (15.0 months vs 7.3 months;
hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). The
benefit was consistent across subgroups. Overall survival (OS) data
were immature at this time, but a clear positive trend has been
observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary
of 0.0098)). Follow-up for OS will continue to the next analysis.
Data available for other secondary endpoints at this analysis
showed clinically meaningful increases in objective response rate,
duration of response and clinical benefit rate.1
“The importance of the PI3K pathway has long been recognised
across many cancers, and inavolisib could transform the way breast
cancer is treated in patients whose tumours harbour PIK3CA
mutations,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “The clinically
meaningful benefit observed with the inavolisib combination speaks
to its potential to become a new standard of care in this patient
population and builds on our commitment to improve outcomes across
all types of breast cancer. We look forward to bringing inavolisib
to patients as soon 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.1 The most
common Grade 3-4 adverse effects (≥ 5 percent) with the inavolisib
combination compared to palbociclib and fulvestrant alone were
neutropenia (80.2% vs 78.4%), thrombocytopenia (14.2% vs 4.3%),
anaemia (6.2% vs 1.9%), stomatitis (5.6% vs 0) and hyperglycaemia
(5.6% vs 0).1 The discontinuation rate in the inavolisib treatment
group was 6.8% compared to 0.6% for palbociclib and fulvestrant
alone.1
Inavolisib, an investigational oral therapy, is currently being
investigated in three Phase III clinical studies in people with
PIK3CA-mutated locally advanced or metastatic breast cancer
(INAVO120, INAVO121, INAVO122).6-8 PIK3CA mutations are found in
approximately 40% of HR-positive breast cancers and can lead to
mutated PI3Kα protein, which contributes to uncontrolled tumour
growth, disease progression and resistance to endocrine-based
treatment. 2,3
Data from the INAVO120 study will be submitted to health
authorities with the view of bringing this potential treatment
option to patients as soon as possible.
About the INAVO120 study6The
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.2 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.4,5
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 versus
palbociclib and fulvestrant in first-line HR-positive,
HER2-negative breast cancer (INAVO120; NCT04191499),6
- in combination with fulvestrant versus alpelisib plus
fulvestrant in HR-positive/HER2-negative breast cancer post-CDK4/6
inhibitor and endocrine combination therapy (INAVO121;
NCT05646862), and7
- in combination with pertuzumab plus trastuzumab for
subcutaneous injection (SC) versus pertuzumab plus trastuzumab for
SC as maintenance therapy in first-line HER2-positive breast cancer
(INAVO122; NCT05894239).8
About hormone receptor-positive breast
cancerHormone receptor (HR)-positive breast cancer is the
most prevalent type of all breast cancers, accounting for
approximately 70% of all cases.9 A defining feature of HR-positive
breast cancer is that its tumour cells have receptors that attach
to one or both hormones – oestrogen or progesterone – which can
contribute to tumour growth.10 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.11-13 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.14
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 oestrogen receptor-positive breast cancer, which
is a form of hormone receptor-positive breast cancer, the most
prevalent type of all breast cancers.
About Roche Founded 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] Jhaveri K et al. Phase III
study of inavolisib or placebo in combination with palbociclib and
fulvestrant in patients with PIK3CA-mutant, hormone
receptor-positive, HER2-negative locally advanced or metastatic
breast cancer: INAVO120 primary analysis. Presented at San Antonio
Breast Cancer Symposium, 2023 December 5-9; San Antonio, USA.
Abstract #GS03-13 [2] André F, et al. Alpelisib for PIK3CA-Mutated,
Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med.
2019;380(20):1929-40[3] He Y, et al. Targeting PI3K/Akt signal
transduction for cancer therapy. Signals Transduction and Targeted
Therapy. 2021; 6: 425[4] 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[5] 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[6]
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[7]
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[8]
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[9]
National Cancer Institute: Surveillance, Epidemiologyand 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[10] Lim
E., et al. The natural history of hormone receptor-positive breast
cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[11]
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[12] 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[13] 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[14] 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
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