Dementia Treatment Development Faces Difficulties... Roche's 'Gantenerumab' Phase 3 Trial Fails

Expectations Rise with Development of 'Pihajuja' Injection

Primary Efficacy Indicator 'CDR-SOB Change at 116 Weeks'
Statistical Significance Not Proven

Roche Headquarters in Basel, Switzerland
[Photo by Reuters]

[Asia Economy Reporter Chunhee Lee] Roche has withdrawn from the competitive race to develop dementia treatments following the success of Biogen and Eisai's Alzheimer's dementia drug 'Lecanemab' in Phase 3 clinical trials. Roche's 'Gantenerumab,' which was under development, failed in a large-scale global Phase 3 clinical trial.

On the 14th (local time), Roche announced that its Phase 3 'GRADUATE' study of Gantenerumab in early Alzheimer's dementia patients failed to meet the primary efficacy endpoint.

Gantenerumab is an amyloid-beta (Aβ) targeting antibody therapy being developed by Roche and Genentech for Alzheimer's dementia. Unlike other intravenous (IV) treatments such as Biogen and Eisai's 'Aduhelm' and 'Lecanemab,' and Eli Lilly's 'Donanemab,' Gantenerumab had raised expectations by developing a subcutaneous (SC) injection formulation to improve dosing convenience.

Roche conducted Phase 3 trials of Gantenerumab under the names 'GRADUATE 1' (982 participants) and 'GRADUATE 2' (1,016 participants). The primary objective of the trials was the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SOB) after 116 weeks.

As a result, the trials showed an additional 6-8% symptom improvement compared to the placebo group, but Roche announced that statistical significance for these results was not achieved. The level of Aβ removal was also lower than expected.

Regarding side effects, ARIA-E, which includes brain vascular edema and extravasation observed in abnormal brain imaging (ARIA), occurred in 25% of the treatment group. Roche explained that "most cases were asymptomatic, and treatment discontinuation was rare." There was no difference in the incidence of ARIA-H, which involves microbleeds and hemosiderosis, between the treatment and placebo groups.

Roche plans to present these topline results at the Alzheimer's Clinical Trials (CTAD) conference on the 30th. CTAD will be held from the 29th to the 2nd of next month in San Francisco, USA.

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