Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine

Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine

Publication date: Dec 02, 2019

SOUTH SAN FRANCISCO, Calif. –(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in the November 27, 2019 online issue of the New England Journal of Medicine (NEJM).

-The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” said Levi Garraway, M. D., Ph. D., chief medical officer and head of Global Product Development.

-Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two Phase III studies, whether given as a monotherapy or in combination with baseline therapy.

Detailed results published in NEJM highlight that in the overall study population, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination with baseline therapy (Hazard Ratio [HR]=0. 38, 95% CI: 0. 16-0. 88; p=0. 02).

In the AQP4-IgG seropositive subgroup analysis, three of 27 patients (11%) treated with satralizumab experienced a PDR compared to 12 of 28 patients (43%) treated with placebo (HR=0. 21, 95% CI: 0. 06-0. 75).

In the AQP4-IgG seronegative subgroup analysis, five of 14 patients (36%) treated with satralizumab experienced a PDR compared to six of 14 patients (43%) receiving placebo (HR= 0. 66, 95% CI: 0. 20-2. 24).

About the SAkuraSky study in NMOSD SAkuraSky is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline immunosuppressant therapy in patients with NMOSD.

Eighty-three male and female patients 13-73 years of age were randomized to either of the following two treatment groups in a 1:1 ratio: satralizumab (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids).

After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period.

Positive Phase III results for satralizumab, as both monotherapy and in combination with baseline immunosuppressant therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD.

Concepts Keywords
Antibodies Antibodies
Astrocytes Biotechnology
Autism Neuroscience
Autoimmune Genentech
Azathioprine Placebo
Biotechnology Azathioprine
Blindness Satralizumab
Blood Serum Aquaporin 4
Brain Multiple sclerosis
Breakthrough Therapy Designation Health
BUSINESS WIRE Neuromyelitis optica
California Monoclonal antibodies
Caucasian Autoimmune diseases
Central Nervous System Clinical medicine
Common Cold Medicine
Corticosteroids Characteristics disorders
Cytokine Play key inflammation
Diagnostic Test Multiple sclerosis
Disability Spinal muscular atrophy
Double Blind Placebo
England Treatment groups
Europe Treatment options
FDA Biotechnology
Gene Http
Genentech
Hazard
Headache
Humanized Monoclonal Antibody
IgG
Immunosuppressant
Inflammation
Interleukin 6
ITT
Japan
Levi
Monotherapy
Multiple Sclerosis
Muscle Weakness
Mycophenolate
Nasopharyngitis
Nervous System
Neurological
Neuromyelitis Optica
Neuroscience
Optic Nerves
Orphan Drug
OTCQX
Paralysis
Pathogenic
Placebo
Primary Endpoint
Protocol
Receptor
Relapse
Seronegative
Seropositive
South San Francisco
SOUTH SAN FRANCISCO
Spectrum
Spinal Cord
Spinal Muscular Atrophy
Subcutaneous Injection
Subcutaneously
United States

Semantics

Type Source Name
disease MESH Neuromyelitis Optica Spectrum Disorder
drug DRUGBANK Mycophenolate mofetil
drug DRUGBANK Azathioprine
disease MESH common cold
disease MESH nasopharyngitis
disease MESH infections
drug DRUGBANK Nonoxynol-9
disease MESH Development
disease MESH relapses
disease MESH multiple sclerosis
disease MESH inflammation
disease MESH paralysis
disease MESH blindness
drug DRUGBANK Coenzyme M
disease MESH autism
disease MESH spinal muscular atrophy
disease MESH death
disease MESH autoimmune disease

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