Roche Hldg - RHHBY STOCK NEWS

Roche has received FDA approval for its PATHWAY HER2 (4B5) test as the first companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for HER2-targeted treatment with ZIIHERA. The test helps identify patients with previously-treated, unresectable or metastatic HER2-positive BTC who may benefit from ZIIHERA treatment. This represents a significant advancement as BTC has treatment options, with most cases diagnosed at advanced stages. The test's approval expands its clinical utility and provides a standardized method for identifying eligible patients for targeted therapy. BTC accounts for 3% of gastrointestinal cancers in the US, with a five-year survival rate of only 19% for localized disease and 3% for metastatic cases.

Roche has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test in Europe for identifying epithelial ovarian cancer patients eligible for ELAHERE treatment. The test detects folate receptor 1 protein, expressed in about 90% of ovarian carcinomas. This certification follows an early exemption approval in Germany and Austria earlier this year. The test aims to enable more precise treatment decisions for ovarian cancer, which causes 46,232 deaths annually in Europe and is the eighth leading cause of cancer death in women worldwide.

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.