PharmaMar moves ahead with NDA for Zepsyre

Although the Phase III trial for lurbinectedin won’t have results for several months yet, PharmaMar is already submitting the drug for approval. The shortcut is possible due to the Accelerated Approval Programme, which was initiated to allow faster approval of drugs for serious conditions that fill an unmet medical need. The filing will be based on data from a Phase II monotherapy basket trial. The trial enrolled a total of 105 patients at 39 centers in more than 9 countries in Western Europe and the United States. The primary endpoint of Overall Response Rate, was achieved by both the investigator and the Independent Review Committee assessment. Secondary endpoints included Duration of Response, Progression-Free Survival, Overall Survival, and safety.

Zepsyre (lurbinectedin) is a selective inhibitor of the oncogenic transcription programmes on which many tumours are particularly dependent. Together with its effecton cancer cells, lurbinectedin inhibits oncogenic transcription in tumour-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumour. It is currently being evaluated in the ATLANTIS trial, which compares Lurbinectedin plus doxorubicin to physician’s choice of either Topotecan or CAV (cyclophosphamide, adriamycin, vincristine) in a 1 to 1 randomization. The primary endpoint is overall survival, and based on the expected number of events, the results are expected around the end of 2019. It is also being evaluated for the treatment of other solid tumours.

Madrid-based PharmaMar anticipates that the NDA filing will take place in the fourth quarter of 2019.