ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Flare Therapeutics and Roche have announced a strategic discovery collaboration focusing on transcription factor targets in oncology. The partnership leverages Flare's proteomic and mass spectrometry platform to discover novel small molecule drugs. Flare will receive US$70 million upfront, with potential milestone payments exceeding US$1.8 billion plus royalties. Flare will lead discovery and preclinical activities, while Roche will handle further development and commercialization. Flare retains rights to co-fund development for one target in exchange for increased US royalties, and maintains ownership of its existing pipeline, including FX-909 for urothelial cancer.

Roche will present over 40 abstracts across nine blood disorders at the 66th ASH Annual Meeting in December 2024. Key highlights include five-year data from the POLARIX study showing positive trends in overall survival for first-line DLBCL patients using Polivy combination therapy. Extended follow-up data of up to four years demonstrates long-lasting remissions for Lunsumio and Columvi in treating follicular lymphoma and DLBCL respectively.

New data for a subcutaneous formulation of Lunsumio shows promising response rates with lower cytokine release syndrome. The STARGLO study reveals comparable quality of life outcomes between treatment arms. Additional presentations include investigational combinations of Polivy with bispecific antibodies, showing potential for earlier treatment lines.

Genentech, part of the Roche Group, will present over 40 abstracts at the 66th ASH Annual Meeting in December 2024, showcasing data across nine blood disorders. Key highlights include five-year data from the POLARIX study showing positive survival trends for Polivy in first-line DLBCL treatment, and extended follow-up data for Lunsumio and Columvi demonstrating lasting remissions in lymphoma patients.

Notable presentations include new data on a subcutaneous formulation of Lunsumio showing high response rates and improved patient experience, and patient-reported outcomes from the STARGLO study supporting Columvi's benefits in DLBCL treatment. The presentations also feature new combination therapy data investigating Polivy with bispecific antibodies.

Roche announced new data for its Elecsys Amyloid Plasma Panel at CTAD congress, demonstrating high accuracy in ruling out Alzheimer's disease. The blood-based test showed a 96.2% negative predictive value in a study of 492 patients across US and Europe, with 91.0% sensitivity and 69.8% specificity. The test combines pTau181 and ApoE4 measurements and received FDA Breakthrough Device Designation in July 2023. This development could potentially eliminate the need for invasive testing, offering a faster and more accessible diagnostic solution for Alzheimer's disease, which currently affects many undiagnosed patients who wait an average of 2.8 years after symptom onset for diagnosis.

Roche announced the publication of phase III INAVO120 trial results for Itovebi in the New England Journal of Medicine. The Itovebi-based regimen showed significant benefits in HR-positive, HER2-negative breast cancer patients with PIK3CA mutations, reducing disease progression or death risk by 57% compared to standard treatment. The median progression-free survival improved to 15.0 months versus 7.3 months with palbociclib and fulvestrant alone. The FDA recently approved this combination as first-line treatment. The PIK3CA mutation affects approximately 40% of HR-positive metastatic breast cancers and is associated with poor prognosis.

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.