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Roche (ROG) investor relations material

Roche Study Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study Update summary11 Dec, 2025

Key study results and clinical impact

  • The phase 3 lidERA trial showed giredestrant significantly improved invasive disease-free survival (IDFS) versus standard endocrine therapy in ER+, HER2-negative early breast cancer, with a hazard ratio of 0.70 and a 3% absolute improvement at three years.

  • Giredestrant reduced the risk of invasive recurrence or death by 30% and distant recurrence by 31%, with early and sustained separation of survival curves.

  • Three-year IDFS rates were 92.4% for giredestrant and 89.6% for standard ET.

  • Benefit was consistent across subgroups, including nodal status, stage, age, menopausal status, prior chemotherapy, region, and risk.

  • OS data were immature but showed a positive trend favoring giredestrant (HR: 0.79; 95% CI: 0.56–1.12).

Safety and tolerability

  • Safety profile was favorable, with lower rates of treatment discontinuation and fatal adverse events compared to standard therapy.

  • Most bradycardia events were mild and asymptomatic.

  • Common adverse events included arthralgia, hot flush, headache, and fatigue, with most being low grade.

  • Safety profiles were comparable between arms, with similar rates of adverse events, serious AEs, and grade 3-4 AEs.

  • Giredestrant had a lower discontinuation rate due to AEs compared to standard ET.

Study design and patient population

  • lidERA is a global, randomized, open-label Phase III trial comparing giredestrant to standard-of-care ET in 4,170 patients with ER+, HER2-negative, Stage I-III early breast cancer.

  • Patients were stratified by risk, region, prior chemotherapy, and menopausal status, with a median follow-up of 32.3 months.

  • The primary endpoint was invasive disease-free survival (IDFS); key secondary endpoints included overall survival (OS), distant recurrence-free interval (DRFI), and safety.

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Frequently asked questions

The Vanguard of Biomedical Innovation

Roche Holding AG, commonly referred to as Roche is a Swiss multinational healthcare company with a rich history dating back to 1896. From its headquarters in Basel, Roche is active with operations in pharmaceuticals and diagnostics, with aportfolio spanning oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. As one of the largest healthcare companies globally, Roche's products and services reach millions of people all over the globe.

From Humble Origins to Global Impact

Founded by Fritz Hoffmann-La Roche, Roche started as a small drug factory but quickly grew to become a leading player in the pharmaceutical industry. In its early years, Roche distinguished itself through its focus on innovation and international outlook, becoming the first company to mass-produce synthetic vitamin C in the 1930s. The company's focus on innovation and the development of new medicines has not wavered since its inception. Roche's pharmaceutical pipeline remains a critical factor in its ongoing growth, continually reinforcing its position as an important player in global healthcare.

What They Do

The company develops and provides innovative healthcare solutions, with a significant emphasis on oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Its pharmaceutical division works to research, develop, and market medications. Simultaneously, its diagnostics division delivers insights into diseases, providing doctors with tools for early detection, targeted treatment, and patient monitoring. Roche is a pioneer in integrated healthcare solutions, deeply investing in genomics and data analytics, underpinning its commitment to personalized medicine. As a global pharmaceutical and healthcare company they compete with names like Novartis, Pfizer, Novo Nordisk, and many others.

Strategic Acquisitions

The company is deeply invested in advancing the understanding and treatment of diseases through genetic insights. This commitment can be exemplified in its acquisition of Foundation Medicine and Flatiron Health, companies specializing in cancer genomics and real-world evidence solutions, respectively. These acquisitions supplement Roche's in-house efforts to develop therapies targeting the genetic drivers of disease.

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