FDA grants Priority Review to Roche’s inavolisib for advanced
hormone receptor-positive, HER2-negative breast cancer with a
PIK3CA mutation
- Priority Review recognises
the best-in-class potential of the inavolisib-based regimen for
patients in urgent need of new treatment
options1,2
- Additional analyses of
INAVO120 will be presented in an oral abstract session at the 2024
American Society of Clinical Oncology Annual Meeting
- The target action date for
the FDA decision is 27 November, 2024
Basel, 29 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the U.S. Food and Drug Administration (FDA)
has accepted the company’s New Drug Application and granted
Priority Review to inavolisib, an investigational, oral therapy, in
combination with palbociclib (Ibrance®) and fulvestrant. The
inavolisib-based regimen was evaluated in adult patients with
PIK3CA-mutated, hormone receptor (HR)-positive, human
epidermal growth factor receptor 2-negative, locally advanced or
metastatic breast cancer, following recurrence on or within 12
months of completing adjuvant endocrine treatment.
The Priority Review is based on the positive Phase III INAVO120
results, which showed the inavolisib-based regimen more than
doubled progression-free survival, reducing the risk of disease
worsening or death 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) in the first-line setting.3
Overall survival (OS) data were immature at the time of primary
analysis, but a clear positive trend was observed (stratified
HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary of
0.0098)).3 Follow-up for OS is continuing to the next
analysis.
“The addition of inavolisib to standard of care treatment
significantly delayed disease progression in the first-line setting
and has the potential to extend survival for people with metastatic
breast cancers that harbour PIK3CA mutations,” said Levi
Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of
Global Product Development. “We welcome the FDA’s Priority Review
designation for inavolisib, which underscores the urgency to bring
this potential best-in-class treatment option to patients as
quickly as possible.”
The PIK3CA mutation is found in approximately 40% of
HR-positive metastatic breast cancers.2 Early testing
for mutations like PIK3CA prior to initiating first-line
treatment can help identify people who may benefit from targeted
therapy.4,5
Based on the Priority Review designation, the FDA has set a
Prescription Drug User Fee Act date of 27 November, 2024. Data from
INAVO120 are also being used for filing submissions to other global
health authorities, including the European Medicines Agency.
Priority Review designation is granted to medicines that the FDA
has determined to have the potential to provide significant
improvements in the treatment, prevention or diagnosis of a
disease.6
Roche recently announced the inavolisib-based regimen has been
granted FDA Breakthrough Therapy Designation based on INAVO120, the
29th for Roche’s oncology portfolio.7 Additional
analyses from INAVO120 will be presented in an oral abstract
session at the 2024 American Society of Clinical Oncology Annual
Meeting, taking place 31 May - 04 June.
Inavolisib is currently being investigated in three
company-sponsored Phase III clinical studies (INAVO120, INAVO121,
INAVO122) in PIK3CA-mutated locally advanced or metastatic
breast cancer in various combinations.8-10 We continue
to evaluate potential clinical development programme expansion
opportunities to address patient unmet needs in various tumour
types across oncology.
About inavolisib
Inavolisib 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
PIK3CA-mutated, hormone receptor-positive, human epidermal
growth factor receptor 2-negative, locally advanced or metastatic
breast cancer, who often have a poor prognosis and are in urgent
need of new treatment options.1-3 Inavolisib has been
designed to help minimise the overall burden and toxicity of
treatment and is differentiated from other PI3K inhibitors due to
its high potency and specificity for the PI3K alpha isoform versus
other isoforms, and unique mechanism of action that facilitates the
degradation of mutated PI3K alpha.11,12
About the INAVO120 study
The 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, human epidermal growth factor receptor 2
(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.8
The study included 325 patients, who were randomly assigned to
either the investigational or control treatment arm.8
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.8 Secondary endpoints
include overall survival, objective response rate, and clinical
benefit rate.8
Beyond INAVO120, inavolisib is currently being investigated in
two additional company-sponsored Phase III clinical studies in
PIK3CA-mutated locally advanced or metastatic breast
cancer in various combinations:
- in combination with fulvestrant versus alpelisib plus
fulvestrant in HR-positive/HER2-negative breast cancer post
cyclin-dependent kinase 4/6 inhibitor and endocrine combination
therapy (INAVO121; NCT05646862), and
- in combination with pertuzumab plus trastuzumab for
subcutaneous injection (SC) versus pertuzumab plus trastuzumab for
SC and optional physician's choice of endocrine therapy as a
maintenance treatment in HER2-positive disease (INAVO122;
NCT05894239).9,10
About hormone receptor (HR)-positive breast
cancer
HR-positive breast cancer is the most prevalent type of all
breast cancers, accounting for approximately 70% of
cases.13,14 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. 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.14-16 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
of intrinsic resistance to standard of care endocrine therapy
in combination with cyclin-dependent kinase 4/6
inhibitors.2
About Roche in breast cancer
Roche 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.13
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 fifteenth 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] Fillbrunn M, et al. PIK3CA mutation status,
progression and survival in advanced HR+/HER2- breast cancer: a
meta-analysis of published clinical trials. BMC Cancer.
2022;22:1002.
[2] Anderson E, et al. A Systematic Review of the Prevalence and
Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic
Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.
[3] 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.
[4] Princic N, et al. Abstract P1-18-18: PIK3CA mutation testing
prevalence among post-menopausal (PM) women with hormone receptor
positive and human epidermal growth factor receptor 2 negative
(HR+/HER2-) metastatic breast cancer (mBC) using real world data.
Cancer Res. 2020;80(4):P1-18-18.
[5] Wales Cancer Network. PIK3CA-mutated breast cancer clinical
guidance document [Internet; cited 2024 May]. Available from:
https://executive.nhs.wales/functions/networks-and-planning/cancer/wcn-documents/mutated-breast-cancer-clinical-guidance-document//.
[6] U.S. Food and Drug Administration. Priority Review [Internet;
cited 2024 May]. Available from:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
[7] U.S. Food and Drug Administration. Breakthrough Therapy
Approvals [Internet; cited 2024 May]. Available from:
https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals.
[8] 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 2024 May]. Available
from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499.
[9] 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 2024 May]. Available from:
https://classic.clinicaltrials.gov/ct2/show/NCT05646862.
[10] 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 2024 May]. Available
from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239.
[11] Juric D, 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.
[12] 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.
[13] National Cancer Institute: Surveillance, Epidemiology and Ends
Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes
[Internet; cited 2024 May]. Available from:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
[14] Lim E, et al. The natural history of hormone receptor-positive
breast cancer. Oncology (Williston Park).
2012;26(8):688-94,696.
[15] 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.
[16] 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.
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