Genentech: Press releases | Sunday, November 13, 2022

Sunday, November 13, 2022

Genentech provides update on GRADUATE Phase III program evaluating gantenerumab in early-stage Alzheimer’s disease

Phase III GRADUATE studies failed to meet primary endpoints of slowing clinical decline in people with early-stage Alzheimer’s disease

The level of beta-amyloid elimination by gantenerumab was lower than expected

Key Data to be Presented at Alzheimer’s Disease Clinical Trials Conference

Genentech is committed to the Alzheimer’s community and will continue to develop new diagnostics and potential treatments for Alzheimer’s disease

South San Francisco, California — November 13, 2022 —

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia, collectively referred to as early-onset Alzheimer’s disease. The studies did not meet their primary endpoints of slowing clinical decline. Gantenerumab was well tolerated, including subcutaneous administration.

“So many of our families have been directly affected by Alzheimer’s disease, so this news is very disappointing,” said Levi Garraway, MD, Ph.D., Chief Medical Officer and Head of Global Product Development. “We are deeply grateful to the study participants, their care partners, and the study sites for their contributions to this research. Although the results from GRADUATE are not what we hoped, we are proud to have provided a high quality, clear and comprehensive dataset on Alzheimer’s disease, and we look forward to sharing our learnings with the community. as we continue to research new treatments for this disease. complex disease.

Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II cycles of -0.31 (p=0.0954) and -0.19 (p=0.2998), respectively, relative to the baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB); however, neither was statistically significant. This represents a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared to placebo. The CDR-SB measures cognitive and functional changes in six domains, including memory, orientation, judgment and problem solving, community affairs, home and leisure, and personal care.

The level of clearance of beta-amyloid, the protein that builds up to form plaques in the brains of people with Alzheimer’s disease, was lower than expected with gantenerumab treatment. Genentech will present key results from the GRADUATE I and II studies at the upcoming Clinical Trials in Alzheimer’s Disease (CTAD) conference on Wednesday, November 30, 2022 at 4:15 p.m. PT.

Amyloid-related imaging abnormalities (ARIAs) are a common radiological finding associated with amyloid-targeted therapies. The incidence of ARIA-E (edema or effusion) in the pooled gantenerumab arms was 25%, with the vast majority asymptomatic and very few resulting in discontinuation of treatment. The incidence of isolated ARIA-H (hemosiderin) was balanced in the gantenerumab and placebo arms.

Genentech remains committed to Alzheimer’s disease, one of the most complex neurological diseases and a major public health issue. The company continues to develop and provide tests to enable early and accurate diagnosis of Alzheimer’s disease and has a pipeline of investigational drugs for different targets, types and stages of the disease.

About the GRADUATE I and II studies

The Phase III GRADUATE I and II studies were two global, double-blind, randomized, placebo-controlled clinical trials evaluating the safety and efficacy of the investigational anti-amyloid monoclonal antibody gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia over 27 months. 1,965 study participants in 30 countries were randomized 1:1 to receive gantenerumab or placebo by titrated subcutaneous injection to reach a target dose of 510 mg administered every other week. The primary endpoint was the change from baseline score on Clinical Dementia Rating – Sum of Boxes (CDR-SB) at 116 weeks. The CDR-SB measures cognitive and functional changes in six domains, including memory, orientation, judgment and problem solving, community affairs, home and leisure, and personal care. There were 17 secondary endpoints, including change in disease severity assessed using various neuropsychological and functional assessment tools (eg, MMSE, ADAS-Cog, etc.), assessment of gantenerumab therapeutic levels, incidence of adverse events, disease biomarkers and scans. A complete list is available at www.clinicaltrials.gov.

About ganterumab

Gantenerumab is a fully human monoclonal IgG1 antibody, an investigational drug administered subcutaneously and designed to target and bind to aggregated forms of beta-amyloid, including oligomers, fibrils and plaques, and activate immune cells of the brain (microglia) to remove amyloid plaques and prevent further buildup. The gantenerumab was discovered in collaboration with MorphoSys.

About Genetetech in Alzheimer’s disease

With more than two decades of scientific research into Alzheimer’s disease, Genentech and Roche are working toward a day when we can detect the disease early and stop its progression to preserve what makes people who they are. Today, the companies’ Alzheimer’s portfolio includes investigational drugs for different targets, types and stages of the disease. It also includes diagnostic tools, including digital blood tests and cerebrospinal fluid (CSF) tests, aimed at detecting, diagnosing and monitoring the disease more effectively. Yet the challenges of Alzheimer’s disease go far beyond the capabilities of science, and having a meaningful impact requires collaboration both within the Alzheimer’s community and outside of health care. Genentech and Roche will continue to work with many partners in the hope of transforming millions of lives.

About Genentech in Neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue breakthrough science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are studying more than a dozen drugs for neurological disorders, including multiple sclerosis, stroke, Alzheimer’s disease, Parkinson’s disease and autism spectrum disorders. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the toughest challenges in neuroscience today.

About Gentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and markets drugs to treat patients with serious and life-threatening diseases. The company, a member of the Roche Group, is headquartered in South San Francisco, California. For more information about the company, please visit http://www.gene.com.

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