SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug major Roche Holding AG (RHHBY)
and its U.S. Unit Genentech announced Tuesday that the U.S. Food and Drug
Administration has granted Breakthrough Therapy Designation for inavolisib to
treat advanced hormone receptor-positive, HER2-negative breast cancer with a
PIK3CA mutation.

The designation has been given to inavolisib, an investigational oral therapy,
in combination with palbociclib (Ibrance) and fulvestrant. It is 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.

The designation is based on Phase III INAVO120 results, which showed that
inavolisib-based regimen more than doubled progression-free survival compared
with palbociclib and fulvestrant alone in the first-line setting.

The companies noted that around 40% of people with HR-positive breast cancer
have a PIK3CA mutation and often face poorer prognosis and resistance to
endocrine treatment.

Overall survival or OS data were immature at this time, but a clear positive
trend has been observed. Follow-up for OS will continue to the next analysis.

The FDA issues Breakthrough Therapy Designation 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.

Roche's oncology portfolio so far has received 29 Breakthrough Therapy
Designation, including the latest one.

Levi Garraway, Roche's Chief Medical Officer and Head of Global Product
Development, said, 'We are pleased that the FDA granted Breakthrough Therapy
Designation for inavolisib in recognition of the substantial clinical benefit
observed with this regimen. 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.'

The company is also submitting the data from INAVO120 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.

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