ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has partnered with Ibex Medical Analytics to enhance digital pathology using AI-based tools focused on cancer diagnostics. This collaboration aims to integrate Ibex's advanced image analysis capabilities into Roche's NAVIFY Digital Pathology platform. The partnership will enable pathologists to improve diagnostic efficiency and accuracy, particularly in breast and prostate cancer detection. Ibex's Galen™ platform has recently received FDA Breakthrough Device Designation, increasing confidence in the technology. Roche remains committed to advancing pathology through innovative partnerships and solutions.

Roche has received FDA approval for Tecentriq as the first cancer immunotherapy for the adjuvant treatment of Stage II-IIIA NSCLC. The decision follows the Phase III IMpower010 study, demonstrating a 34% reduction in disease recurrence risk for patients with PD-L1≥1% tumors compared to best supportive care. This approval introduces new treatment options for patients, marking a significant milestone in lung cancer therapy. Tecentriq is currently available in multiple dosing options and has shown clinical benefits across various lung cancer types.

Roche has partnered with PathAI to leverage artificial intelligence in advancing pathology imaging, enhancing diagnostic accuracy for cancer patients. The collaboration will integrate PathAI’s algorithms into Roche’s NAVIFY Digital Pathology platform, enabling pathologists to access cutting-edge AI tools for improved treatment decisions. This agreement expands Roche’s Digital Pathology Open Environment, supporting the development of companion diagnostics and drug programs across multiple cancer types.

Chugai Pharmaceutical announced new data showing Enspryng's long-term efficacy in preventing relapses in patients with NMOSD. Over four years, 73% of patients in the SAkuraStar study and 71% in the SAkuraSky study remained relapse-free. The safety profile remains consistent across treatment periods, with no new safety signals. Enspryng allows for self-administration, enhancing treatment accessibility. Additionally, the company is launching the SAkuraBONSAI study to further explore disease progression in treatment-naïve patients.

Roche announced positive long-term efficacy results for ENSPRYNG (satralizumab) in preventing relapses in patients with neuromyelitis optica spectrum disorder (NMOSD). Data from the SAkuraStar and SAkuraSky studies show that over 70% of treated individuals remained relapse-free after four years. With a favorable safety profile, ENSPRYNG is now approved in 58 countries, including the U.S. and the EU. New studies, like SAkuraBONSAI, are being initiated to further evaluate its effectiveness and safety.

Roche has received European Medicines Agency (EMA) approval for a 90-minute infusion of Gazyvaro® (obinutuzumab), a significant reduction from the standard 3-4 hour infusion time. This change aims to enhance patient convenience and reduce healthcare system pressures, especially post-COVID-19. The GAZELLE study confirmed no new safety concerns with the shorter infusion. Gazyvaro is already approved for treating follicular lymphoma (FL) and other indications, further solidifying its role in improving patient treatment experiences.

Roche announced significant long-term data on OCREVUS, highlighting a 35% reduction in the risk of needing a walking aid in relapsing multiple sclerosis (RMS) after 7.5 years versus later initiation. There is also a 29% reduction in disability progression in primary progressive MS (PPMS) seen after 8 years. The data, demonstrating a consistent benefit-risk profile, will be presented at the ECTRIMS Congress. Additionally, a shorter 2-hour infusion of OCREVUS was well-tolerated across diverse populations. The outcome reaffirms Roche's commitment to investigate the impacts of COVID-19 in patients treated with OCREVUS.

Roche announced that gantenerumab, an investigational antibody for early Alzheimer's disease, has received Breakthrough Therapy Designation from the FDA. This designation underscores the drug's potential, showing significant reduction in brain amyloid plaque in trials. Currently in Phase III development, the GRADUATE trials are set to evaluate the efficacy and safety of gantenerumab in over 2,000 participants, with completion expected in the second half of 2022. This could mark the first subcutaneous treatment for Alzheimer’s, aiming for at-home administration.

Roche announced that data for OCREVUS (ocrelizumab) and ENSPRYNG (satralizumab) will be presented at the 37th ECTRIMS Congress on October 13-15, 2021. Data shows OCREVUS provides sustained disability reduction for up to 8 years in primary progressive multiple sclerosis (PPMS) and 7.5 years in relapsing MS (RMS). Additionally, long-term safety analyses demonstrate a favorable benefit-risk profile for OCREVUS. ENSPRYNG shows sustained efficacy and safety over four years in neuromyelitis optica spectrum disorder (NMOSD). New studies exploring disease activity in treatment-naïve patients will also be highlighted.