Roche Says Giredrestrant Combination Improved Progression-Free Survival In Phase III Study

By Reuters News

- ROCHE HOLDING AG ROPC.S:

  • ROCHE’S GIREDESTRANT COMBINATION SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN ER-POSITIVE ADVANCED BREAST CANCER IN PHASE III EVERA DATA PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

  • FDA SETS PDUFA GOAL DATE FOR GIREDRESTRANT ON NOV 30 AND DEC 18, 2026

  • GIREDRESTRANT COMBINATION SHOWS MANAGEABLE ADVERSE EVENTS WITH NO UNEXPECTED SAFETY FINDINGS

  • GIREDRESTRANT PLUS EVEROLIMUS REDUCES RISK OF DISEASE PROGRESSION OR DEATH BY 44%-62%

  • MEDIAN PFS 8.8 MONTHS WITH GIREDRESTRANT PLUS EVEROLIMUS IN ITT POPULATION

  • OS DATA SHOW POSITIVE TREND IN ITT AND ESR1-MUTATED POPULATIONS

Further company coverage: ROPC.S

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