ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has obtained CE certification for the VENTANA CLDN18 (43-14A) RxDx Assay, the first companion diagnostic to identify patients with gastric and gastroesophageal junction (GEJ) cancer eligible for targeted treatment with VYLOY. This immunohistochemistry (IHC) test determines CLDN18 protein expression in tumors, helping clinicians identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).

The assay addresses an unmet medical need by enabling personalized treatment options for gastric and GEJ cancer patients. CLDN18.2 is an emerging biomarker that helps predict the likelihood of response to targeted therapy. With gastric cancer being the fifth most common cancer worldwide and having low survival rates, especially in Europe, this diagnostic tool represents a significant advancement in patient care and treatment decision-making.

Roche's commissioned survey reveals significant gaps in public understanding of HPV and cervical cancer across 12 countries in Latin America and Europe. Key findings include:

• Half of respondents have or no awareness of HPV's role in cervical cancer
• Barriers to screening include fear of pain and discomfort discussing sexual history
• Over 70% of respondents are interested in self-collection options for screening

The survey highlights the need for improved education and accessible screening methods. Roche emphasizes the importance of early detection and prevention, aligning with WHO's goal to eliminate cervical cancer globally. The company has joined the Global HPV Consortium and partners with health systems in over 55 countries to support cervical cancer screening programs using the cobas® HPV test.

Roche announced positive topline results from the phase III REGENCY study of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis. The study met its primary endpoint, showing a higher proportion of patients achieving complete renal response (CRR) at 76 weeks when treated with Gazyva/Gazyvaro plus standard therapy compared to standard therapy alone. Two key secondary endpoints also showed statistically significant and clinically meaningful benefits.

Lupus nephritis affects approximately 1.7 million people worldwide, primarily women of color and childbearing age. Despite current treatments, up to one-third of patients progress to end-stage kidney disease within 10 years. Gazyva/Gazyvaro targets disease-causing B cells, potentially preventing or delaying progression to end-stage kidney disease.

Roche plans to share data with health authorities, including the FDA and EMA, aiming to make this potential new treatment available soon. The drug has already received Breakthrough Therapy Designation from the FDA based on phase II NOBILITY study data.

Genentech, a Roche Group member, announced positive Phase III results for Gazyva (obinutuzumab) in treating lupus nephritis. The REGENCY study met its primary endpoint, showing statistically significant and clinically meaningful benefits in patients treated with Gazyva plus standard therapy compared to standard therapy alone.

Key findings include:

• Higher proportion of patients achieved complete renal response (CRR) at 76 weeks
• Statistically significant improvements in CRR with reduced corticosteroid use and proteinuric response
• Safety profile consistent with previous data

Lupus nephritis affects 1.7 million people worldwide, primarily women. Gazyva targets disease-causing B cells, potentially preventing or delaying progression to end-stage kidney disease. The FDA granted Breakthrough Therapy Designation to Gazyva in 2019 based on Phase II data.

Roche has launched the cobas® Respiratory flex test, the first to use its novel TAGS (Temperature-Activated Generation of Signal) technology. This groundbreaking technology enables the detection of up to 15 pathogens in a single PCR test, a significant improvement over the typical four results in current high-throughput analyzers.

The cobas Respiratory flex test can detect 12 common respiratory viruses, including influenza A, influenza B, RSV, and SARS-CoV-2. It offers flexibility for targeted testing, allowing clinicians to specify which pathogens to look for based on various factors. The test runs on the cobas 5800, 6800, and 8800 systems, providing fast and efficient detection without the need for hardware or software upgrades.

This innovation simplifies laboratory logistics, optimizes resource use, and has the potential to revolutionize high-throughput testing for infectious diseases in the future. The test is now available in countries accepting CE-mark, with FDA submission planned for Q4.

Roche announced that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline. Roche's CINtec PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test for triaging HPV-positive cervical cancer screening results. This follows the American Society for Colposcopy and Cervical Pathology (ASCCP)'s recent inclusion of dual-stain testing in its guidelines.

The CINtec PLUS Cytology test detects two biomarkers (p16 and Ki-67) within the same cell, indicating a higher risk of cervical disease. This can help reduce unnecessary colposcopy procedures and allow earlier intervention for high-risk cases. The test uses the same liquid sample as HPV or Pap cytology testing, eliminating the need for additional sample collection.

Roche's entire portfolio of HPV tests on various systems has also received WHO prequalification approval for both clinician-collected and self-collected samples.

Roche announced positive phase III results for Xofluza (baloxavir marboxil) in the CENTERSTONE study, demonstrating its ability to significantly reduce influenza transmission from infected individuals to household members. This marks the first time an antiviral for respiratory illnesses has shown such a benefit in a global phase III study. Xofluza, currently approved for treating symptoms and preventing infection post-exposure, may now offer additional benefits in limiting community spread. The study met its primary endpoint with a single, oral dose, and no new safety concerns were identified. These findings could have significant implications for both seasonal and pandemic influenza management, potentially easing the burden on healthcare systems worldwide.

Genentech, a Roche Group member, announced FDA approval of Ocrevus Zunovo™ for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This is the first twice-yearly, 10-minute subcutaneous injection approved for both MS forms, expanding treatment options.

Key points:

• Builds on a decade of Ocrevus® IV safety and efficacy data
• Offers flexibility for healthcare providers and patients
• After the first dose, treatment time could be as little as 55 minutes
• Phase III OCARINA II trial showed consistent efficacy with IV formulation
• 92% of trial participants reported satisfaction with subcutaneous administration

Roche has received FDA approval for Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy. This new formulation offers greater flexibility in treatment options, reducing administration time from 30-60 minutes to approximately seven minutes. It's approved for all adult indications of IV Tecentriq in the U.S., including certain types of lung, liver, skin, and soft tissue cancers.

The approval is based on the IMscin001 study, which showed comparable efficacy and safety to the IV formulation. The IMscin002 study revealed that 71% of patients preferred Tecentriq Hybreza over IV administration, with 79% choosing to continue treatment with the subcutaneous option. This development aligns with Roche's commitment to improving patient experience and offering diverse treatment options.