Roche (ROG) Study Update summary

Strategic pipeline and portfolio update

• Multiple positive phase 3 readouts in Q4, including Gazyva in kidney disease, fenebrutinib in MS, and giredestrant in breast cancer, have significantly improved long-term growth outlook.

• Peak sales expectations raised for Gazyva (up to CHF 2B) and fenebrutinib (now >CHF 3B).

• Giredestrant's US filing is imminent, with launch expected in 2026 for second-line breast cancer.

• Several NMEs are approaching near-term filing, with up to four possible by 2030.

• Pharma growth now expected until 2030 and beyond, driven by recent trial successes and expanded pipeline.

Background and study rationale

• ER+, HER2-negative early breast cancer represents over 70% of early breast cancers, with endocrine therapy as the mainstay treatment.

• Despite curative intent, up to 25% of patients relapse within 5 years, highlighting the need for more effective and better-tolerated adjuvant ET.

• Giredestrant is a next-generation oral SERD designed for deep and sustained ER inhibition, showing superior preclinical potency and antiproliferative activity compared to other SERDs and 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, distant recurrence-free interval, and safety.