On November 8, 2018 Zepsyre (lurbinectedin), from PharmaMar (MSE:PHM), reported noteworthy clinical activity in patients with metastatic breast cancer that have mutations in the BRCA 1 and/or BRCA 2 genes (Press release, PharmaMar, NOV 8, 2018, View Source [SID1234531166]). This is the conclusion contained in the "The Lancet Oncology" and the "Journal of Clinical Oncology", in their September and November issues, respectively; both having published the positive results of PharmaMar’s phase II trial.

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This trial intended to assess the clinical activity of lurbinectedin in patients affected by metastatic breast cancer in BRCA 1 and/or BRCA 2 gene mutations. It is important to highlight that in the patients with BRCA2 mutations, the confirmed overall response rate (ORR) was observed to be 61%, the median progression-free survival (PFS) was observed to be 5.9 months and the median overall survival (OS) was observed to be 26.6 months.

In the prior, untreated PARP population, the confirmed ORR was 72%, this being the highest reported figure in this tumor setting so far. The 54 breast cancer patients with mutations in the BRCA 1 and/or BRCA 2 genes
included in the trial were recruited from 11 research centers in the United States and Spain.

"Lurbinectedin is a selective inhibitor of active transcription of protein-coding genes," explained by Judith Balmaña (Vall d’Hebron Institute of Oncology) in The Lancet Oncology. "In this phase II trial, it showed a notable efficacy in patients with metastatic breast cancer and a germline BRCA1/2 mutation."

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