Roche Hldg - RHHBY STOCK NEWS

Genentech's Itovebi demonstrates significant results in Phase III INAVO120 study for HR-positive advanced breast cancer, published in the New England Journal of Medicine. The Itovebi-based regimen showed a 57% reduction in disease progression or death risk compared to standard treatment, extending progression-free survival from 7.3 to 15.0 months. The FDA recently approved Itovebi combined with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative breast cancer. The mutation occurs in about 40% of HR-positive metastatic breast cancers and typically indicates poor prognosis. Early survival data shows positive trends, with continued follow-up planned.

Roche reported strong Group sales growth of 6% (CER) to CHF 45.0 billion in the first nine months of 2024, with a notable 9% increase in Q3. The Pharmaceuticals Division saw 7% growth to CHF 34.3 billion, driven by newer medicines like Vabysmo, Phesgo, and Ocrevus. The Diagnostics Division grew 5% to CHF 10.7 billion.

Key achievements include US approvals for Itovebi (breast cancer), Ocrevus Zunovo (multiple sclerosis), and Tecentriq Hybreza (cancer), plus EU approvals for Vabysmo (eye disease) and PiaSky (blood condition). Positive phase III data was reported for several medicines including Gazyva/Gazyvaro and Xofluza.

Roche announced positive one-year results from the ELEVATUM study, evaluating Vabysmo® (faricimab) for 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 (CST) from baseline

The study included 124 participants, with 45% self-identifying as Hispanic or Latino and 48% as Black or African American. Vabysmo was well-tolerated, with no new safety events identified. These results are consistent with previous phase III studies and demonstrate Vabysmo's effectiveness in treating DME in underrepresented populations.

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.