Genentech Provides Update on Phase III Studies of Etrolizumab in People With Moderately to Severely Active Ulcerative Colitis

• Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies
• Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis
• Analyses of these data are ongoing to better understand the results
• Pivotal Phase III study of etrolizumab in Crohn’s disease is ongoing
• Genentech is studying additional investigational medicines in inflammatory bowel diseases

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced topline results from its Phase III study program evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo.

In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint. In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four Phase III clinical trials reported to date.

“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are fully analyzing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial program ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation.”

Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.

Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global Phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease. In addition, Genentech is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.

About inflammatory bowel diseases and ulcerative colitis

Inflammatory bowel diseases (IBD) are a group of chronic gastrointestinal disorders affecting almost 7 million people worldwide. The two main types of IBD are ulcerative colitis (mainly affecting the colon and rectum) and Crohn’s disease (affecting the entire gastrointestinal tract). Patients can experience unpredictable symptoms that include abdominal pain and cramping, frequent and urgent bowel movements, diarrhea, leakage, rectal bleeding, weight loss, energy loss and fatigue. About 80% of all individuals with IBD do not experience lasting remission, which can have a long-term impact on quality of life and leave many feeling like they have little control over their daily lives.

Ulcerative colitis is most commonly diagnosed in young people aged 15 to 30 years, affecting them over the course of their entire future lives. Up to a quarter of people with ulcerative colitis will require a colectomy within 10 years of diagnosis, in which all or part of the colon is removed.

About etrolizumab

Etrolizumab is the first investigational dual anti-integrin studied in inflammatory bowel diseases (IBD). It is designed to target IBD on two fronts by selectively inhibiting α4β7 and αEβ7 to control both trafficking of immune cells into the gut and their inflammatory effects on the gut lining.

About the etrolizumab study program

Etrolizumab is being studied in the largest clinical trial program in inflammatory bowel diseases to date, comprised of eight randomized-controlled and open-label trials. The landmark study program includes more than 3,100 patients across six Phase III studies, plus two open-label extension (OLE) and safety monitoring studies for ulcerative colitis and Crohn’s disease, spanning more than 40 countries globally, including head-to-head trials against the most common current treatments.

The etrolizumab study program consists of:

• Phase III HIBISCUS I and II: Two identical, randomized, double-blind, double-dummy, placebo-controlled, multicenter studies evaluating the efficacy (induction of remission) and safety of etrolizumab versus adalimumab and placebo in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-tumor necrosis factor (anti-TNF) agents.
• Phase III LAUREL: Randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy (maintenance of remission) and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents.
• Phase III GARDENIA: Randomized, multicenter double-blind, double-dummy study evaluating the efficacy (sustained remission) and safety of etrolizumab versus infliximab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents.
• Phase III HICKORY: Double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of etrolizumab during induction and maintenance in patients with moderately to severely active ulcerative colitis who have been previously treated with anti-TNF agents.
• COTTONWOOD study: An open-label extension and safety monitoring study of patients with moderately to severely ulcerative colitis previously enrolled in etrolizumab Phase II/III studies.
• Phase III BERGAMOT: A Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of etrolizumab as an induction and maintenance treatment in patients with moderately to severely active Crohn’s disease.
• JUNIPER study: An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the etrolizumab Phase III BERGAMOT study.

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.

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