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Phase III GiACTA Study Shows Genentech (RHHBY)’s Actemra Is Superior To Steroids Alone In Maintaining Steroid-Free Remission For People With Giant Cell Arteritis



11/14/2016 10:03:22 AM

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• 56 percent of patients treated with Actemra achieved steroid-free disease remission at one year, versus 14 percent with a six-month steroid only taper regimen1

• There have been no therapies approved for giant cell arteritis (GCA) in more than 50 years

• Results will be submitted to regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA), by the end of 2016

SOUTH SAN FRANCISCO, CA — November 12, 2016 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III GiACTA study, which evaluated Actemra® (tocilizumab) in people with GCA. GiACTA met its primary and key secondary endpoint, demonstrating that Actemra – initially in combination with a six-month steroid (glucocorticoid) taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone.1 Data results will be presented in an oral session on Sunday, November 13 at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting.

“Treatment to date for GCA has been limited to high-dose steroids to rapidly control inflammation and prevent serious complications,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “However, steroid treatment often fails to control disease in the long-term and can be associated with severe side effects. If approved, Actemra could have the potential to fundamentally change the way people with GCA are treated.”

The primary endpoint of the study was met, with Actemra – initially combined with a six-month steroid taper regimen – significantly increasing the proportion of patients achieving sustained remission at one year (56 percent [QW; p <0.0001] and 53.1 percent [Q2W; p<0.0001]) versus 14 percent with a six-month steroid taper regimen given alone.1

The study also met its key secondary endpoint, demonstrating that Actemra – initially combined with a six-month steroid taper regimen – significantly increased the proportion of patients achieving sustained remission at one year (56 percent [QW; p <0.0001] and 53.1 percent [Q2W; p= 0.0002]) compared to 17.6 percent with a 12-month steroid taper regimen given alone.1

No new safety signals were observed1 and these results are consistent with Actemra’s documented safety profile in rheumatoid arthritis (RA).

A 104-week open label extension study from GiACTA is still ongoing. Data from this analysis will quantify Actemra’s long-term safety and maintenance of efficacy beyond one year, as well as any potential long-term steroid sparing effects. Actemra has been granted Breakthrough Therapy Designation for GCA by the FDA. This designation is designed to expedite the development and review of medicines intended to treat serious diseases, and to help ensure patients have access to them as soon as possible. GiACTA builds on our wealth of knowledge and experience with Actemra in RA and demonstrates Genentech’s commitment to follow the science, and to do now what patients need next.

About the GiACTA study

GiACTA (NCT01791153) is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary and key secondary endpoints were evaluated at 52 weeks.

About Giant Cell Arteritis

The prevalence of GCA has been estimated at over 200 per 100,000 persons in the U.S. over the age of 50, and the disease is two to three times more likely to affect women than men.2,3 GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke.2 Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ‘emergency’ treatment option to prevent damage such as vision loss. However, steroids do not always maintain long-term disease control (flare-free remission).4,5,6 Due to the variety of symptoms, complexity of the disease and its complications, people with GCA are often seen by several physicians including rheumatologists, neurologists and ophthalmologists.

About Actemra

Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. In addition, Actemra is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older. Actemra is not approved for subcutaneous use in people with PJIA or SJIA.

Actemra is intended for use under the guidance of a healthcare practitioner.

Important Safety Information

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

· Stomach tears

· Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels

· An increased risk of certain cancers by changing the way a patient’s immune system works

· Hepatitis B infection

· Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection.

· Nervous system problems

Patients should tell their doctor if they are allergic to Actemra or if they have had a bad reaction to Actemra previously. Common side effects in patients with RA treated with Actemra: Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

· Upper respiratory tract infections (like common cold and sinus infections)

· Headache

· Increased blood pressure (also called hypertension)

· Injection site reactions

Common side effects in patients with PJIA or SJIA treated with Actemra:

· Upper respiratory tract infections (like common cold and sinus infections)

· Headache

· Diarrhea

Actemra & pregnancy:

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Call Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

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.

References

1. Stone, J et al. Efficacy and safety of tocilizumab in patients with giant cell arteritis: week 52 results from a phase 3, multicenter, randomized, double-blind placebo-controlled trial. Presented at the 2016 American College of Rheumatology

2. Bhat S, et al. Giant cell arteritis. Midlife and Beyond, GM, Rheumatology, February 2010; 071-079

3. Lawrence C, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis & Rheum 1998; 41:778-799

4. Balsalobre A, et al. Temporal Arteritis: Treatment Controversies. Neurologia. 2010; 25(7): 453-458

5. Ponte C, et al. Giant cell arteritis: Current treatment and management. World J Clin Cases, 2015 June 16; 3(6): 484-494. DOI: 10.12998/wjcc.v3.i6.484

6. Chatterjee S, et al. Clinical Diagnosis and Management of Large Vessel Vasculitis: Giant Cell Arteritis. Curr Cardiol Rep (2014) 16:498. DOI 10.1007/s11886-014-0498-z

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