ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced the European Medicines Agency's CHMP recommendation for conditional marketing authorization for mosunetuzumab, a bispecific antibody for treating relapsed or refractory follicular lymphoma (FL). If approved, it will be the first CD20xCD3 therapy available for this condition. The recommendation stems from the GO29781 study, which demonstrated a 60% complete response rate among heavily pretreated patients. More than 28,000 people are diagnosed with FL yearly in Europe, highlighting the need for effective treatment options. A final decision by the European Commission is anticipated soon.

Roche will showcase innovative diagnostics solutions at the 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine (EuroMedLab) in Munich from April 10-14, 2022. Key highlights include the cobas® 5800 System for expanded PCR testing and the handheld cobas® pulse glucose management device. Additionally, Roche will present the AVENIO Tumor Tissue Comprehensive Genomic Profiling Kit study results to aid oncology research. The company emphasizes its commitment to improving patient care and healthcare efficiency through digital solutions and integrated diagnostics.

Genentech announced promising interim results from the CONSONANCE study of Ocrevus (ocrelizumab) for treating secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS). Seventy-five percent of patients exhibited no evidence of progression (NEP) after one year. Moreover, 70% showed improvement in cognitive stability. The study revealed disparities in treatment initiation among minority populations, which the company aims to address through ongoing research. Ocrevus has been administered to over 225,000 patients globally, demonstrating significant long-term efficacy.

Roche announced the FDA's acceptance of the supplemental Biologics License Application for Actemra/RoActemra (tocilizumab) to treat COVID-19 in hospitalized adults. If approved, it would be the first FDA-approved immunomodulator for this indication. Over one million patients have been treated globally with Actemra/RoActemra. The submission is based on clinical studies involving over 5,500 patients and a decision on approval is expected in the second half of 2022. Roche is committed to improving access to this treatment worldwide, especially in low- and middle-income countries.

Roche (OTCQX: RHHBY) announced new findings on OCREVUS® (ocrelizumab) demonstrating significant benefits for patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS). An interim analysis of the CONSONANCE study showed that 75% of patients achieved no evidence of progression (NEP) after one year, while 70% exhibited stable or improved cognition. The study also highlighted treatment disparities, noting that fewer Black and Hispanic patients initiate high-efficacy treatments. OCREVUS has been administered to over 225,000 patients globally, supported by over 450,000 patient years of data.

Genentech, a member of the Roche Group, announced that the Phase III SKYSCRAPER-02 study of tiragolumab combined with Tecentriq and chemotherapy did not meet its co-primary endpoint of progression-free survival for extensive-stage small cell lung cancer (ES-SCLC). The overall survival results were also not statistically significant. Despite this setback, tiragolumab remains under evaluation for non-small cell lung cancer through additional trials. The company continues its commitment to develop innovative cancer treatments.

Roche's phase III SKYSCRAPER-02 study of tiragolumab in extensive-stage small cell lung cancer (ES-SCLC) has reported disappointing results, failing to meet its co-primary endpoint of progression-free survival. Although the combination treatment was well-tolerated, the interim analysis revealed that overall survival is unlikely to achieve significance in future evaluations. Roche remains committed to developing tiragolumab in other cancer types, continuing its exploration of innovative therapies to enhance treatment options for patients with hard-to-treat cancers.

Roche has received a positive recommendation from the European Medicines Agency's CHMP for Polivy® (polatuzumab vedotin) combined with R-CHP therapy for previously untreated diffuse large B-cell lymphoma (DLBCL). This regimen marked the first significant improvement in patient outcomes in over 20 years, highlighting a need for better treatment options for the 40% of patients unresponsive to current therapies. Based on the POLARIX study, Polivy plus R-CHP demonstrated a 27% improvement in progression-free survival compared to traditional R-CHOP treatment, with comparable safety profiles.

On March 25, 2022, Roche announced new data concerning its neuroscience portfolio to be presented at the 74th AAN Annual Meeting from April 2-7, 2022. Key highlights include:

• OCREVUS: First data on disability progression in non-active secondary progressive multiple sclerosis.
• EVRYSDI: Long-term safety and efficacy in spinal muscular atrophy.
• ENSPRING: Reinforced long-term efficacy in neuromyelitis optica spectrum disorder.
• New findings in Alzheimer’s disease to enhance understanding of early treatment impact.