Zepsyre (lurbinectedin; PharmaMar/Chugai) is a novel synthetic agent derived from the marine-derived alkaloid trabectedin that inhibits the transcription process. Zepsyre covalently bonds to the minor groove of DNA and is associated with the degradation of phosphorylated RNA polymerase II and the induction of DNA breaks, which ultimately cause cell apoptosis.
Zepsyre may face competition from other late-phase drug candidates targeting the platinum-resistant setting, but early-phase data indicate that it is significantly more potent than topotecan, which is a standard chemotherapy choice for these patients. PharmaMar and Chugai are investigating Zepsyre in the Phase III CORAIL trial (ClinicalTrials.gov identifier: NCT02421588) against PEGylated liposomal doxorubicin or topotecan to confirm these results. Improved efficacy and/or tolerability over these chemotherapies in a pivotal Phase III trial would give Zepsyre an advantage over potential competitors.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Zepsyre : Ovarian cancer
LIST OF FIGURES 8 Figure 1: Zepsyre for ovarian cancer – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment of Zepsyre for ovarian cancer
10 Figure 3: Datamonitor Healthcare’s drug assessment of Zepsyre for ovarian cancer
LIST OF TABLES 5 Table 1: Zepsyre drug profile
6 Table 2: Zepsyre Phase III trial in ovarian cancer
6 Table 3: Phase II data for Zepsyre in ovarian cancer
7 Table 4: Ongoing Phase Ib/II trial of Zepsyre in ovarian cancer
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