Once approved, PharmaMar’s lurbinectedin (PM1183) will be marketed under the brand name Zepsyre as a treatment for solid tumors in ovarian, lung, and breast cancers.
Zepsyre is in its final stage of development as an anticancer treatment. Selecting a brand name is part of the approval process by the European Medicines Agency and the U.S. Food and Drug Administration before a drug reaches market.
“We trust in the potential of Zepsyre as a therapeutic alternative due to its novel mechanism of action and the antitumoral activity observed in all clinical trials for different type of tumors,” Luis Mora, managing director of PharmaMar’s Oncology Business Unit, said in a news release.
Zepsyre works by inhibiting RNA polymerase II, an enzyme essential for protein production, causing cancer cell death and halting tumor growth.
In a Phase 2 clinical trial for ovarian cancer patients who did not respond to platinum-based chemotherapy, treatment with Zepsyre induced an overall response rate of 22% and a disease control rate of 71%. Researchers also found that Zepsyre reverses IRF-1-dependent resistance to Platinol (cisplatin) in ovarian cancer tumors.
Zepsyre’s efficacy and safety also are being studied in two Phase 3 trials — one in platinum-resistant ovarian cancer (NCT02421588) and another in platinum-resistant small-cell lung cancers (ATLANTIS, NCT02566993). The endpoints in these studies are a change in progression-free-survival (PFS) induced by the treatment, overall survival, and overall response rate.
A Phase 2 trial with BRCA-mutated metastatic breast cancer patients (NCT01525589) showed that Zepsyre induced an overall response rate of 41%, meeting the study’s primary objective. PharmaMar plans to launch a pivotal Phase 3 study in patients with this disease as well.
Ovarian cancer develops when cells in the ovaries grow out of control, mainly affecting older women (half of the women diagnosed with ovarian cancer are 63 or older). It is more common among Caucasian women than African-American women.
According to estimates by the American Cancer Society, about 22,440 women in the U.S. will be diagnosed with ovarian cancer in 2017.