Genentech Says SUMMACTA Study Meets Primary Endpoint
"We are very pleased with these data showing that subcutaneous administration of ACTEMRA provides clinically meaningful and comparable results to the IV infusion," said Hal Barron, M.D., chief medical officer and head, Global Product Development. “This may provide patients and their doctors with an important additional treatment option."
Preliminary safety analysis showed that the adverse event profiles of the SC and IV groups were comparable with no new clinically meaningful safety signals identified. Data from SUMMACTA will be submitted for presentation at an upcoming medical meeting. The results of BREVACTA, a second study assessing ACTEMRA SC formulation administered every two weeks versus placebo SC, are anticipated later in 2012. Following completion of the two studies Genentech will evaluate plans to submit SUMMACTA and BREVACTA data to health authorities in the U.S.
SUMMACTA is a randomized, double-blind, active controlled, parallel group, multicenter, two-year study with a double-blind period of 24 weeks with two treatment arms, followed by an open-label period of 72 weeks with some SC and IV switching. The trial is a non-inferiority design and randomized 1,262 patients with moderately to severely active RA who have had an inadequate response to disease-modifying antirheumatic drug (DMARD) therapies that may have included (in up to 20 percent of patients) one or more tumor necrosis factor (TNF) antagonist therapies into two treatment arms. Patients in group A received ACTEMRA 162 mg SC weekly and those in group B received ACTEMRA 8 mg/kg IV every four weeks.
Secondary endpoints include assessments at Week 24 of the proportion of patients in each group with an ACR50 response; an ACR70 response; DAS 28 low disease activity; decrease of = 0.3 in the Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline to Week 24 and the proportion of patients who withdrew due to lack of therapeutic response. Further analysis will assess long-term safety profile and efficacy; pharmacokinetics (PK) and pharmacodynamics (PD) of ACTEMRA SC; immunogenicity of ACTEMRA SC; and the effect of switching from one formulation to another on the safety, efficacy, PK and PD of ACTEMRA.
About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Important Safety Information
Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
Common side effects with ACTEMRA in rheumatoid arthritis include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com 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 India, Brazil, Switzerland and Australia.
Founded more than 30 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.
Joe St. Martin, 650-467-6800
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 85 03