ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced FDA acceptance of a supplemental Biologics License Application (sBLA) for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The application is based on the Phase III STARGLO study, which demonstrated statistically significant improvement in overall survival compared to Rituxan with GemOx.

The FDA decision is expected by July 20, 2025. This treatment could provide an off-the-shelf, fixed-duration option for patients who aren't eligible for stem cell transplant. Columvi is currently approved in over 50 countries as a monotherapy for R/R DLBCL after two or more lines of systemic therapy.

Roche has announced a definitive merger agreement to acquire Poseida Therapeutics for US $9.00 per share in cash, with a total equity value of approximately US $1.0 billion. Stockholders will receive an additional non-tradeable contingent value right (CVR) of up to US $4.00 per share, potentially bringing the total deal value to US $1.5 billion. The acquisition, expected to close in Q1 2025, builds on their existing 2022 partnership and focuses on developing off-the-shelf CAR-T cell therapies. Poseida's portfolio includes pre-clinical and clinical-stage therapies for hematological malignancies, solid tumors, and autoimmune diseases, along with manufacturing capabilities and technology platforms.

Roche reports that the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® versus Tecentriq alone in PD-L1-high non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoint of overall survival at final analysis. The global, randomized, double-blind study involved 534 patients with previously untreated, locally advanced unresectable or metastatic NSCLC. The safety profile remained consistent with longer follow-up, showing no new safety signals. Detailed data will be presented at a medical meeting in 2025.

Genentech announces that its Phase III SKYSCRAPER-01 study, testing tiragolumab combined with Tecentriq versus Tecentriq alone in PD-L1-high non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoint of overall survival. The global, randomized, double-blinded study involved 534 previously untreated patients with locally advanced unresectable or metastatic NSCLC. While the safety profile remained consistent with no new signals identified, detailed data will be presented at a medical meeting in 2025. The company plans to review its study programs and expects additional Phase III data across different settings next year.

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.