Roche Hldg Stock Price, News & Analysis

Genentech announced positive one-year results from the ELEVATUM study, evaluating Vabysmo for treating diabetic macular edema (DME) in underrepresented racial and ethnic groups. The study showed:

• Participants could read an additional 12.3 letters on average after one year of treatment
• Hispanic and Latino participants gained an average of 14.1 letters
• African American and Black participants gained an average of 11.3 letters
• A decrease of 206.3 microns in central subfield thickness, indicating retinal drying

The study included 45% Hispanic or Latino and 48% Black or African American participants. Results were consistent with previous Phase III studies, and Vabysmo was well-tolerated with no new safety events identified. This first-of-its-kind study aims to address health disparities and improve clinical trial representation for populations disproportionately affected by DME.

Roche has received FDA approval 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) assay helps determine CLDN18 protein expression in tumors, enabling clinicians to identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).

The assay addresses an unmet medical need by helping predict the likelihood of response to targeted therapy in gastric and GEJ cancers. CLDN18.2 is an emerging biomarker in these cancers. This approval aligns with current guidelines recommending biomarker use to guide therapeutic decision-making in gastric/GEJ cancer.

Gastric cancer is the fifth most common cancer and fourth leading cause of cancer deaths worldwide. In the U.S., 62% of gastric/GEJ cancer cases are advanced at initial diagnosis, with a five-year overall survival rate of only 6%.

Roche presented positive two-year data from the RAINBOWFISH study at the 29th World Muscle Society Congress, evaluating Evrysdi® (risdiplam) in children with spinal muscular atrophy (SMA) treated pre-symptomatically before six weeks of age. The study found:

• Majority of children achieved key motor milestones
• All children could swallow and feed orally
• No children required permanent ventilation
• Cognitive skills were typical of children without SMA

Children with three or more SMN2 copies (n=18) achieved 100% standing and walking milestones. Those with two SMN2 copies (n=5) could all sit, and 60% could stand and walk independently after two years. The study reported no deaths or adverse events leading to withdrawal. Evrysdi is the only non-invasive SMA therapy approved in over 100 countries, with more than 16,000 people treated globally.

Genentech presented positive 2-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society Congress, evaluating Evrysdi® (risdiplam) in children with Spinal Muscular Atrophy (SMA) treated pre-symptomatically before 6 weeks of age. The study found that the majority of children achieved key motor milestones, were able to swallow and feed orally, and demonstrated typical cognitive skills, with none requiring permanent ventilation.

All children with three or more SMN2 copies achieved standing and walking milestones, while all children with two SMN2 copies could sit and most could stand and walk independently after 2 years of treatment. The study also assessed cognition as an exploratory endpoint, showing cognitive skills typical of children without SMA.

Evrysdi is the only non-invasive SMA therapy approved in over 100 countries, with more than 16,000 people treated globally. The treatment was well-tolerated, with no deaths or adverse events leading to withdrawal or treatment discontinuation.

Roche has received FDA approval for Itovebi™ (inavolisib), a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval is based on the Phase III INAVO120 study results, which showed that the Itovebi-based regimen more than doubled progression-free survival compared to standard treatment in the first-line setting.

Itovebi, in combination with palbociclib and fulvestrant, is approved for adults with endocrine-resistant, PIK3CA-mutated breast cancer following recurrence on or after adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.

The INAVO120 study demonstrated that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. Itovebi will be available in the US in the coming weeks, marking an important step in Roche's efforts to bring innovative medicines to more people with breast cancer.

Genentech, a Roche Group member, announced FDA approval of Itovebi™ (inavolisib), in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer in adults. The approval is based on the Phase III INAVO120 study, which showed the Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 vs 7.3 months). This new treatment addresses an urgent unmet need for people with PIK3CA mutations, found in about 40% of HR-positive metastatic breast cancers. The regimen reduced the risk of disease worsening or death by 57%. Itovebi will be available in the U.S. in the coming weeks, marking Genentech's first targeted therapy for HR-positive breast cancer, the most prevalent subtype.

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.