Categorynews

Genentech to Present New OCREVUS (Ocrelizumab) Data Analyses Showing Significant Reduction of Disability Progression in Relapsing and Primary Progressive Multiple Sclerosis at the AAN Annual Meeting

May 8, 2019 Off By BusinessWire

New analyses show the effect of OCREVUS on reducing the risk of
disability progression is associated with exposure and lower B-cell
levels
Long-term data in RMS and PPMS show that earlier treatment with
OCREVUS significantly reduced the risk of permanent disability
progression
Over 100,000 people have been treated with OCREVUS globally, in
clinical trial and real-world settings; data presented at the AAN
Annual Meeting highlights a consistent and favorable benefit-risk
profile

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced new OCREVUS^® (ocrelizumab) data in relapsing
and primary progressive multiple sclerosis (MS) were presented at the
71st American Academy of Neurology (AAN) Annual Meeting from May 4-10 in
Philadelphia, Pennsylvania. New analyses on OCREVUS show its effect on
reducing the risk of disability progression is associated with higher
exposure to the medicine and lower B-cell levels, and show the positive
impact of OCREVUS in significantly reducing disability progression.

With rapidly growing real-world experience and more than 100,000
patients treated globally, OCREVUS is the first and only therapy with
six-month dosing approved for both relapsing MS (RMS), (including RRMS
and active, or relapsing, secondary progressive MS) and primary
progressive MS (PPMS). Additionally, new safety data presented at AAN
representing 4,501 patients with RMS and PPMS and 12,559 patient years
of exposure to OCREVUS, across all OCREVUS clinical trials, remain
consistent with the medicine’s favorable benefit-risk profile.

“These are the first data to show that higher OCREVUS exposure is
associated with greater control of disability progression without
impacting safety,” said Stephen Hauser, M.D., chair of the Scientific
Steering Committee of the OPERA studies and director of the Weill
Institute for Neurosciences at the University of California, San
Francisco. “These analyses, along with long-term data that show OCREVUS
reduced the risk of permanent disability progression, create a
compelling case for initiating therapy early in the disease course and
provide important information that clinicians can use to inform
treatment decisions.”

New data from pharmacokinetic, pharmacodynamic and exposure analyses –
or how OCREVUS is processed in an individual’s body over time – show
higher exposure to OCREVUS correlated with lower B-cell levels and lower
rates of disability progression in patients. In patients with RMS,
OCREVUS reduced the risk of 24-week confirmed disability progression
(CDP) at all exposure levels compared with interferon beta-1a. There was
lower risk of disability progression with higher exposure to OCREVUS.

A similar pattern was observed for patients with PPMS, in which OCREVUS
reduced the risk of 24-week CDP at all exposure levels compared with
placebo. OCREVUS reduced T1 gadolinium-enhancing and new/enlarging T2
MRI lesions to nearly undetectable levels in RMS and PPMS patients and
reduced annualized relapse rates to low levels (0.13-0.18) in RMS
patients across all exposure segments. Notably, safety findings remained
consistent across all OCREVUS exposure levels, suggesting that higher
exposure does not increase the likelihood of adverse events.

Long-term data, of over five years, from the Phase III OPERA and
ORATORIO open-label extension (OLE) trials in RMS and PPMS, show that
earlier treatment with OCREVUS significantly reduced the risk of
permanent disability progression and this effect was sustained over
time. In the OPERA OLE, the proportion of RMS patients with 48-week CDP
was lower for those treated with continuous OCREVUS (total of five years
on OCREVUS) compared with patients who switched to OCREVUS after two
years of interferon beta-1a treatment in the double-blind period (total
of three years on OCREVUS) (10.4% vs. 15.7%; p=0.004). In the ORATORIO
OLE, the proportion of PPMS patients with 48-week CDP was lower in those
treated with continuous OCREVUS over five and a half years compared with
patients who switched to OCREVUS from placebo after the 120-week
double-blind period (43.7% vs. 53.1%; p=0.03).

Additionally, interim results of the Phase III Ocrelizumab Biomarker
Outcome Evaluation (OBOE) study show that OCREVUS reduced the presence
of a nerve cell damage and inflammation biomarker in serum and
cerebrospinal fluid at 12, 24 and 52 weeks in patients with RMS. These
one-year data add to the growing body of evidence to identify biomarkers
of disease progression in MS and the benefit of OCREVUS on these markers.

OCREVUS is now approved in 85 countries across North America, South
America, the Middle East, Eastern Europe, as well as in Australia,
Switzerland and the European Union.

Full session details and data presentation listings for the 2019 AAN
Annual Meeting can be found at the meeting website: https://www.aan.com/conferences-community/annual-meeting/.

Follow Genentech on Twitter via @Genentech and keep up to date with AAN
2019 Annual Meeting news and updates by using the hashtag #AANAM.

About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA I and OPERA II are Phase III, randomized, double-blind,
double-dummy, global multi-center studies evaluating the efficacy and
safety of OCREVUS (600 mg administered by intravenous infusion every six
months) compared with interferon beta-1a (44 mcg administered by
subcutaneous injection three times per week) in 1,656 people with
relapsing forms of MS. In these studies, relapsing MS (RMS) was defined
as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS)
with relapses. A similar proportion of patients in the OCREVUS group
experienced serious adverse events and serious infections compared with
patients in the high-dose interferon beta-1a group in the RMS studies.

About the ORATORIO study in primary progressive MS

ORATORIO is a Phase III, randomized, double-blind, global multi-center
study evaluating the efficacy and safety of OCREVUS (600 mg administered
by intravenous infusion every six months; given as two 300 mg infusions
two weeks apart) compared with placebo in 732 people with primary
progressive MS (PPMS). The blinded treatment period of the ORATORIO
study continued until all patients had received at least 120 weeks of
either OCREVUS or placebo and a predefined number of confirmed
disability progression (CDP) events was reached overall in the study. A
similar proportion of patients in the OCREVUS group experienced adverse
events and serious adverse events compared with patients in the placebo
group in the PPMS study.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects nearly one
million people in the U.S., for which there is currently no cure. MS
occurs when the immune system abnormally attacks the insulation and
support around nerve cells (myelin sheath) in the brain, spinal cord and
optic nerves, causing inflammation and consequent damage. This damage
can cause a wide range of symptoms, including muscle weakness, fatigue
and difficulty seeing, and may eventually lead to disability. Most
people with MS experience their first symptom between 20 and 40 years of
age, making the disease the leading cause of non-traumatic disability in
younger adults.

Relapsing-remitting MS (RRMS) is the most common form of the disease and
is characterized by episodes of new or worsening signs or symptoms
(relapses) followed by periods of recovery. Approximately 85 percent of
people with MS are initially diagnosed with RRMS. The majority of people
who are diagnosed with RRMS will eventually transition to secondary
progressive MS (SPMS), in which they experience steadily worsening
disability over time. Relapsing forms of MS (RMS) include people with
RRMS and people with SPMS who continue to experience relapses. Primary
progressive MS (PPMS) is a debilitating form of the disease marked by
steadily worsening symptoms but typically without distinct relapses or
periods of remission. Approximately 15 percent of people with MS are
diagnosed with the primary progressive form of the disease. Until the
FDA approval of OCREVUS, there had been no FDA approved treatments for
PPMS.

People with all forms of MS experience disease activity – inflammation
in the nervous system and permanent loss of nerve cells in the brain –
even when their clinical symptoms aren’t apparent or don’t appear to be
getting worse. An important goal of treating MS is to reduce disease
activity as soon as possible to slow how quickly a person’s disability
progresses. Despite available disease-modifying treatments (DMTs), some
people with RMS continue to experience disease activity and disability
progression.

About OCREVUS^® (ocrelizumab)

OCREVUS is a humanized monoclonal antibody designed to target
CD20-positive B cells, a specific type of immune cell thought to be a
key contributor to myelin (nerve cell insulation and support) and axonal
(nerve cell) damage. This nerve cell damage can lead to disability in
people with multiple sclerosis (MS). Based on preclinical studies,
OCREVUS binds to CD20 cell surface proteins expressed on certain B
cells, but not on stem cells or plasma cells, and therefore important
functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The
initial dose is given as two 300 mg infusions given two weeks apart.
Subsequent doses are given as single 600 mg infusions.

Important Safety Information

What is OCREVUS?

OCREVUS is a prescription medicine used to treat adults with relapsing
or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

Who should not receive OCREVUS?

Do not receive OCREVUS if you have an active hepatitis B virus
(HBV) infection.

Do not receive OCREVUS if you have had a life threatening
allergic reaction to OCREVUS. Tell your healthcare provider if you have
had an allergic reaction to OCREVUS or any of its ingredients in the
past.

What is the most important information I should know about OCREVUS?

OCREVUS can cause serious side effects, including:

Infusion reactions: OCREVUS can cause infusion reactions that
can be serious and require you to be hospitalized. You will be
monitored during your infusion and for at least 1 hour after each
infusion of OCREVUS for signs and symptoms of an infusion reaction.
Tell your healthcare provider or nurse if you get any of these
symptoms:
- itchy skin
- rash
- hives
- tiredness
- coughing or wheezing
- trouble breathing
- throat irritation or pain
- feeling faint
- fever
- redness on your face (flushing)
- nausea
- headache
- swelling of the throat
- dizziness
- shortness of breath
- fatigue
- fast heart beat
These infusion reactions can happen for up to 24 hours after your
infusion. It is important that you call your healthcare provider
right away if you get any of the signs or symptoms listed above after
each infusion.

If you get infusion reactions, your
healthcare provider may need to stop or slow down the rate of your
infusion.

Infection:
- OCREVUS increases your risk of getting upper respiratory tract
  infections, lower respiratory tract infections, skin infections,
  and herpes infections. Tell your healthcare provider if you have
  an infection or have any of the following signs of infection
  including fever, chills, a cough that does not go away, or signs
  of herpes (such as cold sores, shingles, or genital sores). These
  signs can happen during treatment or after you have received your
  last dose of OCREVUS. If you have an active infection, your
  healthcare provider should delay your treatment with OCREVUS until
  your infection is gone.
- Progressive Multifocal Leukoencephalopathy (PML): Although
  no cases have been seen with OCREVUS treatment in clinical trials,
  PML may happen with OCREVUS. PML is a rare brain infection that
  usually leads to death or severe disability. Tell your healthcare
  provider right away if you have any new or worsening neurologic
  signs or symptoms. These may include problems with thinking,
  balance, eyesight, weakness on 1 side of your body, strength, or
  using your arms or legs.
- Hepatitis B virus (HBV) reactivation: Before starting
  treatment with OCREVUS, your healthcare provider will do blood
  tests to check for hepatitis B viral infection. If you have ever
  had hepatitis B virus infection, the hepatitis B virus may become
  active again during or after treatment with OCREVUS. Hepatitis B
  virus becoming active again (called reactivation) may cause
  serious liver problems including liver failure or death. Your
  healthcare provider will monitor you if you are at risk for
  hepatitis B virus reactivation during treatment and after you stop
  receiving OCREVUS.
- Weakened immune system: OCREVUS taken before or after other
  medicines that weaken the immune system could increase your risk
  of getting infections.

Before receiving OCREVUS, tell your healthcare provider about all of
your medical conditions, including if you:

have ever taken, take, or plan to take medicines that affect your
immune system, or other treatments for MS.
have ever had hepatitis B or are a carrier of the hepatitis B virus.
have had a recent vaccination or are scheduled to receive any
vaccinations.
- You should receive any required ‘live’ or ‘live-attenuated’
  vaccines at least 4 weeks before you start treatment with OCREVUS.
  You should not receive ‘live’ or ‘live attenuated’ vaccines
  while you are being treated with OCREVUS and until your healthcare
  provider tells you that your immune system is no longer weakened.
- When possible, you should receive any ‘non-live’ vaccines at
  least 2 weeks before you start treatment with OCREVUS. If you
  would like to receive any non-live (inactivated) vaccines,
  including the seasonal flu vaccine, while you are being treated
  with OCREVUS, talk to your healthcare provider.
- If you are pregnant or planning to become pregnant talk to your
  doctor about vaccinations for your baby, as some precautions may
  be needed.
are pregnant, think that you might be pregnant, or plan to become
pregnant. It is not known if OCREVUS will harm your unborn baby. You
should use birth control (contraception) during treatment with OCREVUS
and for 6 months after your last infusion of OCREVUS.
are breastfeeding or plan to breastfeed. It is not known if OCREVUS
passes into your breast milk. Talk to your healthcare provider about
the best way to feed your baby if you take OCREVUS.

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.

What are the possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

Risk of cancers (malignancies) including breast cancer. Follow
your healthcare provider’s instructions about standard screening
guidelines for breast cancer.

Most common side effects include infusion reactions and infections.

These are not all the possible side effects of OCREVUS.

Call your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088.

For more information, go to http://www.OCREVUS.com
or call 1-844-627-3887.

For additional safety information, please see the OCREVUS full Prescribing
Information and Medication Guide.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech
and Roche. The company’s goal is to develop treatment options based on
the biology of the nervous system to help improve the lives of people
with chronic and potentially devastating diseases. Genentech and Roche
have more than a dozen investigational medicines in clinical development
for diseases that include multiple sclerosis, spinal muscular atrophy,
neuromyelitis optica spectrum disorder, Alzheimer’s disease,
Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy
and autism.

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.