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Roche Pill Cuts Breast Cancer Recurrence 30% in Phase III Trial

The Phase III data were unveiled at the San Antonio Breast Cancer Symposium, highlighting a potential shift in adjuvant endocrine care.

The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo

Overview

  • At three years, 92.4% of patients on giredestrant were alive and disease-free versus 89.6% on standard endocrine therapy, according to detailed lidERA results.
  • The global, randomized trial enrolled 4,170 stage I–III, HR-positive, HER2-negative patients post-surgery and compared 30 mg daily giredestrant with physician’s choice of tamoxifen or aromatase inhibitors over five years.
  • Giredestrant reduced invasive disease progression by 30% at a median 32.3 months of follow-up and cut distant recurrences by 31%, with overall survival data still immature but trending positive.
  • Adverse events were generally similar between arms; bradycardia occurred more often with giredestrant (11.3% vs 3.2%) and was mostly asymptomatic grade 1, and treatment discontinuations were lower with giredestrant (5.3% vs 8.2%).
  • Roche and investigators said the results indicate clinical superiority over long-standing endocrine options, with potential to become a new adjuvant standard as questions persist about which patients may still need CDK4/6 inhibitors such as Novartis’ Kisqali; JPMorgan estimates a multi‑billion‑dollar opportunity if approved.