* 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(1)

  * Approximately 40% of people with HR-positive breast cancer have a PIK3CA
    mutation and often face poorer prognosis and resistance to endocrine
    treatment(2,3 )
  * This is the 29th Breakthrough Therapy Designation for Roche's oncology
    portfolio, a testament to our enduring ambition to deliver transformative
    medicines for patients(4)

Basel, 21 May 2024 - Roche (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., Roche'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.(5)
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,
pÂ