– The designation is based on Phase III
INAVO120 results, showing the inavolisib-based regimen more than
doubled progression-free survival compared with palbociclib and
fulvestrant alone in the first-line setting –
– Approximately 40% of people with HR-positive
breast cancer have a PIK3CA mutation and often face poorer
prognosis and resistance to endocrine treatment –
– This is the 29th Breakthrough Therapy
Designation for Genentech’s oncology portfolio, a testament to our
enduring ambition to deliver transformative medicines for patients
–
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation for inavolisib,
an investigational oral therapy, in combination with palbociclib
(Ibrance®) and fulvestrant, for the treatment of adult patients
with PIK3CA-mutated, hormone receptor-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.
“We are pleased that the FDA granted Breakthrough Therapy
Designation for inavolisib in recognition of the substantial
clinical benefit observed with this regimen,” said Levi Garraway,
M.D., Ph.D., Genentech’s chief medical officer and head of Global
Product Development. “This promising inavolisib-based regimen could
transform the PI3K inhibitor class, potentially becoming the
standard of care for this patient population in the first-line
setting.”
Breakthrough Therapy Designation is designed to accelerate the
development and regulatory review of medicines intended to treat
serious or life-threatening conditions where preliminary clinical
evidence has indicated they may demonstrate substantial improvement
over existing therapies.
The FDA’s decision is based on positive Phase III INAVO120
results, which showed the inavolisib-based regimen reduced the risk
of disease worsening or death (progression-free survival) 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).
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. These data reinforce the potential
for this inavolisib-based regimen to benefit patients with
PIK3CA-mutated locally advanced or metastatic breast cancer.
PIK3CA is one of the most commonly mutated genes in advanced or
metastatic breast cancer. Despite the prevalence of PIK3CA
mutations, many patients are not tested until later in their
treatment journey. Early testing for PIK3CA prior to initiating
first-line treatment helps clinicians make a personalized treatment
decision.
Data from INAVO120 are also being submitted to other global
health authorities, including the European Medicines Agency.
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. We continue to evaluate potential
clinical development program expansion opportunities to address
patient unmet needs in various tumor 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, HR-positive, HER2–negative, locally advanced or
metastatic breast cancer, who often have a poor prognosis and are
in urgent need of new treatment options. Inavolisib has been
designed to help minimize 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.
About the INAVO120 study
The INAVO120 study [NCT04191499] is a Phase III, randomized,
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 randomization 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.
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 dual HER2 blockade vs dual HER2 blockade
and optional physician's choice of endocrine therapy as a
maintenance treatment in HER2-positive disease (INAVO122;
NCT05894239).
About Hormone Receptor-Positive Breast Cancer
HR-positive breast cancer is the most prevalent type of all
breast cancers, accounting for approximately 70% of cases. A
defining feature of HR-positive breast cancer is that its tumor
cells have receptors that attach to one or both hormones – estrogen
or progesterone – which can contribute to tumor 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. The PI3K signaling 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.
About Genentech in Breast Cancer
Genentech 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 substantially improved outcomes for HER2-positive
breast cancer. 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 Genentech
Founded more than 40 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious and
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
All trademarks used or mentioned in this release are protected
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