Brief: Delcath Systems Inc Announces Positive Phase 3 Trial Results For Hepzato™ In Liver-Dominant Metastatic Ocular Melanoma

Delcath Systems

02/12/2021 14:17

Dec 2 (Reuters) - Delcath Systems Inc  DCTH.O :
    * DELCATH SYSTEMS, INC. ANNOUNCES POSITIVE PHASE 3 FOCUS
TRIAL
RESULTS FOR HEPZATO™ IN LIVER-DOMINANT METASTATIC OCULAR
MELANOMA, INCLUDING INITIAL SURVIVAL DATA ANALYSIS
    * DELCATH SYSTEMS - ON FINAL ANALYSIS OF PRIMARY ORR
ENDPOINT,
HEPZATO FURTHER EXCEEDED PREDEFINED THRESHOLD FOR SUCCESS WITH
MEDIAN DURATION OF RESPONSE OF 14 MONTHS
    * DELCATH SYSTEMS INC - INTEND TO STUDY HEPZATO IN
ADDITIONAL
INDICATIONS IN NEAR FUTURE
    * DELCATH SYSTEMS INC- DISEASE CONTROL RATE OF 73.6% VERSUS
37.5%
FOR PATIENTS IN BAC ARM FOR HEPZATO STUDY
    * DELCATH SYSTEMS INC - AS OF THE ANALYSIS, SURVIVAL AT
12-MONTHS
IN EVALUABLE PATIENTS WAS 75% IN HEPZATO ARM VERSUS 47% FOR BAC
    * DELCATH SYSTEMS INC - HEPZATO HAD STATISTICALLY
SIGNIFICANT
IMPROVEMENTS OVER BAC IN PREDEFINED EXPLORATORY ANALYSES ON ORR,
DCR AND PFS
    * DELCATH SYSTEMS INC - NDA RESUBMISSION FOR HEPZATO
EXPECTED BY
MID-2022
    * DELCATH SYSTEMS INC- MEDIAN PROGRESSION FREE SURVIVAL OF
9.03
MONTHS VERSUS 3.12 MONTHS FOR BAC ARM IN HEPZATO STUDY

Source text for Eikon:  ID:nGNX226NC4 
Further company coverage:  DCTH.O 

 ((Reuters.Briefs@thomsonreuters.com;;))