Brief: Seagen Phase 3 Trial Of Tukysa (Tucatinib) In Combination With Antibody-Drug Conjugate ADO-Trastuzumab Emtansine Meets Primary Endpoint

Seagen

16/08/2023 13:17

Aug 16 (Reuters) - Seagen Inc  SGEN.O :
    * SEAGEN PHASE 3 TRIAL OF TUKYSA® (TUCATINIB) IN COMBINATION
WITH
ANTIBODY-DRUG CONJUGATE ADO-TRASTUZUMAB EMTANSINE MEETS PRIMARY
ENDPOINT OF PROGRESSION-FREE SURVIVAL IN PATIENTS WITH
PREVIOUSLY TREATED HER2-POSITIVE METASTATIC BREAST CANCER
    * SEAGEN INC - OVERALL SURVIVAL (OS) DATA, A SECONDARY
ENDPOINT,
ARE NOT YET MATURE.
    * SEAGEN INC - DISCONTINUATIONS DUE TO ADVERSE EVENTS WERE
MORE
COMMON IN COMBINATION ARM OF TRIAL, BUT NO NEW SAFETY SIGNALS
EMERGED FOR COMBINATION
    * SEAGEN INC - PLAN TO PRESENT HER2CLIMB-02 DATA AT AN
UPCOMING
MEDICAL MEETING AND DISCUSS RESULTS WITH FDA
    * SEAGEN INC - TUKYSA CAN CAUSE SEVERE DIARRHEA INCLUDING
DEHYDRATION, HYPOTENSION, ACUTE KIDNEY INJURY, AND DEATH
    * SEAGEN - IN HER2CLIMB, WHEN TUKYSA GIVEN IN COMBINATION
WITH
TRASTUZUMAB AND CAPECITABINE, 81% OF PATIENTS WHO RECEIVED
TUKYSA EXPERIENCED DIARRHEA
    * SEAGEN - IN HER2CLIMB, BOTH PATIENTS WHO DEVELOPED GRADE 4
DIARRHEA SUBSEQUENTLY DIED, WITH DIARRHEA AS A CONTRIBUTOR TO
DEATH
    * SEAGEN INC - TUKYSA CAN CAUSE FETAL HARM
    * SEAGEN INC - IN HER2CLIMB, SERIOUS ADVERSE REACTIONS
OCCURRED IN
26% OF PATIENTS
    * SEAGEN - FATAL ADVERSE REACTIONS OCCURRED IN 2% OF
PATIENTS WHO
RECEIVED TUKYSA INCLUDING SUDDEN DEATH, SEPSIS, DEHYDRATION, AND
CARDIOGENIC SHOCK
    * SEAGEN INC - IN MOUNTAINEER, SERIOUS ADVERSE REACTIONS
OCCURRED
IN 22% OF PATIENTS
    * SEAGEN INC - ADVERSE REACTIONS LEADING TO PERMANENT
DISCONTINUATION OF TUKYSA OCCURRED IN 6% OF PATIENTS IN
MOUNTAINEER

Source text for Eikon:  ID:nBw2nmfwPa 
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