Roche's (RHHBY) Genentech Announces Actemra Phase 3 Met Primary, Secondary Endpoints in Steroid-Free Remission for GCA Patients

November 13, 2016 9:10 AM EST
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Genentech, a member of the Roche Group (OTC: RHHBY), 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.



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