FDA Grants Genentech’s Cancer Immunotherapy Atezolizumab Priority Review for Advanced Bladder Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
accepted the company’s Biologics License Application (BLA) and granted
Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the
treatment of people with locally advanced or metastatic urothelial
carcinoma (mUC) who had disease progression during or following
platinum-based chemotherapy in the metastatic setting, or whose disease
worsened within 12 months of receiving platinum-based chemotherapy
before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial
carcinoma accounts for 90 percent of all bladder cancers and can also be
found in the renal pelvis, ureter and urethra.

“Atezolizumab was granted Priority Review designation based on results
of the IMvigor 210 study, which showed the medicine shrank tumors in a
type of advanced bladder cancer, and the majority responding to
treatment continued to respond after nearly a year of follow up,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. “The treatment options available for advanced bladder
cancer are very limited, and we are committed to working with the FDA to
bring the first anti-PDL1 cancer immunotherapy to people with this
disease as quickly as possible.”

A Priority Review designation is granted to medicines that the FDA has
determined to have the potential to provide significant improvements in
the safety and effectiveness of the treatment, prevention or diagnosis
of a serious disease. Atezolizumab was granted Breakthrough Therapy
Designation by the FDA in May 2014 for the treatment of people whose
metastatic bladder cancer expresses the protein PD-L1 (programmed death
ligand-1). Breakthrough Therapy Designation is designed to expedite the
development and review of medicines intended to treat serious or
life-threatening diseases and to help ensure that people have access to
them through FDA approval as soon as possible. The BLA submission for
atezolizumab is based on results of the IMvigor 210 Phase II study, and
the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab
is also being studied in a number of other cancers.

About the IMvigor 210 study

IMvigor 210 is an open-label, multicenter, single-arm Phase II study
that evaluated the safety and efficacy of atezolizumab in people with
locally advanced or mUC, regardless of PD-L1 expression. People in the
study whose disease had progressed during or following previous
treatment with a platinum-based chemotherapy regimen (n=311) received a
1200-mg intravenous dose of atezolizumab on day one of 21-day cycles
until loss of clinical benefit. The primary endpoint of the study was
objective response rate (ORR) as assessed by an independent review
facility (IRF) using Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1. Secondary endpoints included duration of response (DOR),
overall survival, progression-free survival and safety.

In an updated analysis based on 11.7 months of median follow up,
atezolizumab shrank tumors (ORR) in 15 percent (95 percent CI: 11, 19)
of people evaluable for efficacy and safety (n=310) whose disease
progressed after platinum-based chemotherapy. Atezolizumab shrank tumors
in 26 percent (95 percent CI: 18, 36) of people whose disease had medium
and high levels of PD-L1 expression (n=100). Median DOR was not reached
at the time of analysis; with a median duration of follow up of 11.7
months, 84 percent (38/45) of people had an ongoing response. The most
common Grade 3 to 4 treatment-related adverse events included: fatigue
(2 percent), decreased appetite, fever (pyrexia), anemia, enzymes in the
blood (ALT and AST increase), joint pain (arthralgia), difficulty
breathing (dyspnea), inflammation of the lung wall (pneumonitis),
inflammation of the lining of the colon (colitis), hypertension and
hypotension (all 1 percent). There were no treatment-related Grade 5
adverse events.

In addition to IMvigor 210, Genentech has an ongoing, confirmatory Phase
III study (IMvigor 211), which compares atezolizumab to chemotherapy in
people whose bladder cancer has progressed on at least one prior
platinum-containing regimen.

About metastatic urothelial cancer

According to the American Cancer Society (ACS), it is estimated that
more than 76,000 Americans will be diagnosed with bladder cancer in
2016, and about 11 percent of new diagnoses are made when bladder cancer
is in advanced stages. There is a dramatic difference in survival rates
between early and advanced bladder cancer. The ACS estimates that
approximately 96 percent of people will live five or more years when
diagnosed with the earliest stage of the disease, compared to 39 percent
when diagnosed in advanced stages (stage III-IV) of the disease. Men are
about three to four times more likely to get bladder cancer during their
lifetime than women.

About atezolizumab

Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational
monoclonal antibody designed to bind with a protein called programmed
death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to
PD-L1 expressed on tumor cells and tumor-infiltrating immune cells,
blocking its interactions with PD-1 and B7.1 receptors. By inhibiting
PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab
may also affect normal cells.

About Genentech in Personalized Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the
goal to redefine treatment in oncology. Today, we’re investing more than
ever to bring personalized cancer immunotherapy (PCI) to people with
cancer. The goal of PCI is to provide each person with a treatment
tailored to harness his or her own immune system to fight cancer.
Genentech is studying more than 20 investigational medicines, nine of
which are in clinical trials. In every study we are evaluating
biomarkers to identify which people may be appropriate candidates for
our medicines. For more information visit http://www.gene.com/immunotherapy.

About Genentech

Founded 40 years ago, Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes medicines to treat
patients with serious or 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.


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