April 4, 2018 / 10:58 AM / 8 months ago

BRIEF-Lilly Announces CYRAMZA Phase 3 REACH-2 Study Met Overall Survival Endpoint

April 4 (Reuters) - Eli Lilly and Co:

* LILLY ANNOUNCES CYRAMZA® (RAMUCIRUMAB) PHASE 3 REACH-2 STUDY IN SECOND-LINE HEPATOCELLULAR CARCINOMA PATIENTS MET OVERALL SURVIVAL ENDPOINT

* TRIAL ‍MET ITS PRIMARY ENDPOINT OF OVERALL SURVIVAL (OS) AS WELL AS SECONDARY ENDPOINT OF PROGRESSION-FREE SURVIVAL (PFS)​

* ‍CYRAMZA HAS NOW DEMONSTRATED A SURVIVAL BENEFIT IN FOUR AGGRESSIVE, DIFFICULT-TO-TREAT TUMOR TYPES IN PHASE 3 STUDIES​TREAT TUMOR TYPES IN PHASE 3 STUDIES​

* LILLY INTENDS TO INITIATE REGULATORY SUBMISSIONS IN MID-2018

* SAFETY PROFILE OBSERVED IN REACH-2 STUDY WAS CONSISTENT WITH WHAT HAS BEEN PREVIOUSLY OBSERVED FOR SINGLE-AGENT CYRAMZA

* ONLY GRADE ≥3 ADVERSE EVENTS OCCURRING AT A RATE OF 5 PERCENT OR GREATER IN CYRAMZA ARM WERE HYPERTENSION AND HYPONATREMIA

* AN ONGOING PHASE 3 TRIAL IN ADVANCED UROTHELIAL CARCINOMA HAS MET ITS PRIMARY ENDPOINT OF PFS, AND OS DATA EXPECTED IN H1 2018

* ‍ANOTHER ONGOING PHASE 3 STUDY OF CYRAMZA IN EGFR-POSITIVE NON-SMALL CELL LUNG CANCER IS ONGOING, WITH EXPECTED PFS DATA READOUT IN LATE 2018​​ Source text for Eikon: Further company coverage:

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