Announcement • 17h

Roche Presents New Data in Alzheimer’S Disease Portfolio At Aaic 2026

Roche announced that it will present new data from its Alzheimer’s disease portfolio at the Alzheimer’s Association International Conference 2026 (AAIC) in London on 12-15 July. These data demonstrate how Roche is advancing the development of next-generation medicines and diagnostic tests. There are 18 oral and poster presentations. Highlights include five oral presentations as part of a trontinemab Featured Research Session, an oral Perspectives Session on neuroimmune targets such as NLRP3 for neurodegenerative diseases, and presentations on the use of Roche's Elecsys pTau217 and pTau181 blood tests to support Alzheimer’s disease diagnosis. Trontinemab is an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody. Presenters will share new long-term safety, amyloid removal and biomarker data from the Phase Ib/IIa Brainshuttle AD open-label extension study. Modelling from this study has informed the dosing regimen for the ongoing Phase III TRONTIER 1 and 2 studies in early symptomatic Alzheimer’s disease. Roche will also share the design of PrevenTRON, a Phase III study investigating trontinemab in preclinical Alzheimer’s disease. PrevenTRON is planning to recruit cognitively unimpaired individuals at high risk of progression to symptomatic Alzheimer’s, and investigators are using Roche’s Elecsys pTau217 blood test to help identify potential study participants. AAIC has invited Roche to present a Perspectives Session on the NLRP3 inflammasome in Alzheimer’s disease. Emerging preclinical and clinical data on the immunomodulatory effects of NLRP3 inhibition in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease will also be presented. Roche’s Elecsys pTau217 blood test recently received CE mark certification as both a rule-in and rule-out test of amyloid pathology to aid in Alzheimer’s disease diagnosis, and data will be presented evaluating the test’s performance in primary and secondary care settings. New data will be presented for the approved Elecsys pTau181 blood test for ruling out Alzheimer’s disease, which explores sample stability under different storage conditions and test performance across large, diverse, cognitively impaired patient populations to support implementation of the test in routine clinical practice. Roche is sponsoring a symposium “Closing the Diagnostic Gap: Utilizing pTau217 for Scalable Alzheimer’s Disease Diagnosis” on Sunday 12 July at 12:30-13:45 BST at the Crowne Plaza London Docklands Hotel. The symposium will discuss the evolving role of blood-based biomarkers in the early detection and diagnosis of Alzheimer’s disease, including the potential of scalable blood testing approaches designed to help reduce diagnostic barriers, enable earlier identification of individuals at risk, and support broader access to disease-modifying therapies in clinical practice. Trontinemab Long-Term Safety and Amyloid Removal with Trontinemab: Interim Data from the Open-Label Extension of the Phase Ib/IIa Brainshuttle AD Study. Interim Long-Term Biomarker Results from the Trontinemab Open-Label Extension of the Phase Ib/IIa Brainshuttle AD Study. Simulation of Amyloid Clearance in Phase III Studies with Trontinemab in Early Symptomatic Alzheimer’s Disease. Evidence Supporting Preclinical AD as an Optimal Stage for Intervention with Trontinemab. PrevenTRON: Rationale and Design of a Phase III Trial of Trontinemab in Cognitively Unimpaired Individuals with Biomarkers of Alzheimer’s Disease at High Risk of Clinical Decline. The Role of NLRP3 in Alzheimer's Disease: Reverse Translational Data from GRADUATE Ph3 Trials. Investigating the Role of the NLRP3 Inflammasome in the Pathogenesis of Alzheimer’s Disease. External Controls Vs. Observed Placebo: How Close Can We Get? GRADUATE I and II Results. Tau Pathology Interferes with Amyloid Removal by Gantenerumab. Burden and Support Needs of Informal Caregivers of People Living with Alzheimer’s Disease in Three Countries. Mental Health Conditions in Spouses of People Living with Alzheimer's Disease: A Longitudinal US Claims Data Analysis. Expanding Clinical Trial Access to Underrepresented Populations in the U.S.: Findings from the Alzheimer’s Disease Pre-Screener Study. A Low-Burden Cognitive Prescreening Protocol for Enhanced Diversity and Recruitment in Roche’s Alzheimer’s Disease Clinical Trials. Rule-Out Performance of a Plasma pTau181 Immunoassay at Established Cutoffs in Subgroups Across a Large, Diverse, Cognitively Impaired Population. Evaluating a Future In Vitro Diagnostic pTau217 Plasma Assay for the Detection of Amyloid Pathology in Primary and Secondary Care Settings. Elecsys pTau181 Plasma Immunoassay Performance Against Centiloid-Based Amyloid Classification Across Clinical Stages. Elecsys Cerebrospinal Fluid Biomarker Ratio Concordance with Amyloid-Positron Emission Tomography in a Chinese Population. Sample Stability for a New pTau181 Plasma Immunoassay: Implications for Rule-Out Testing for Alzheimer’s Disease in Routine Clinical Practice.

Announcement • Jul 02

Roche Reports Positive Results from Phase Iii Krascendo 1 Study Evaluating Divarasib Against Approved Kras G12c Inhibitors in Previously Treated Kras G12c Non-Small Cell Lung Cancer

Roche announced positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. Data will be submitted to health authorities and presented at an upcoming medical meeting. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer (NSCLC). Data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible. The Krascendo 1 study is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first generation KRAS G12C inhibitors. This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutant advanced or metastatic non-small cell lung cancer. The study includes 338 adults, randomised to receive either divarasib (once daily) or, either sotorasib (once daily) or adagrasib (twice daily). The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival. Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures. Divarasib is an investigational, next-generation, oral, KRAS G12C inhibitor. It has shown greater potency and selectivity in preclinical studies compared with first generation KRAS G12C-targeting treatments, sotorasib and adagrasib. Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (‘off’) state, thereby turning off its tumour-driving signalling. Divarasib’s comprehensive clinical development programme is anchored by three phase III studies: Krascendo 1 (divarasib monotherapy vs sotorasib or adagrasib in previously treated KRAS G12C-mutant advanced or metastatic NSCLC), Krascendo 2 (divarasib plus pembrolizumab (chemotherapy-free combination) vs chemotherapy plus pembrolizumab in previously untreated KRAS G12C-mutant advanced NSCLC), and Krascendo 3 (adjuvant divarasib monotherapy vs immunotherapy or observation in resected stage II–IIIB KRAS G12C-mutant NSCLC after standard of care chemoimmunotherapy).

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Roche Reports Positive Results from Phase Iii Krascendo 1 Study Evaluating Divarasib Against Approved Kras G12c Inhibitors in Previously Treated Kras G12c Non-Small Cell Lung Cancer

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