EU filing for Clovis’ Rubraca in ovarian cancer maintenance setting

Clovis Oncology is seeking to expand use of its PARP inhibitor Rubraca in Europe to include maintenance treatment of certain adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The company wants to target the drug’s use towards patients who are in complete or partial response to platinum based chemotherapy.

Rubraca (rucaparib) is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes that block the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die.

In May, the drug became the first PARP inhibitor licensed in the EU as a monotherapy treatment for women with recurrent BRCA mutant ovarian cancer, in who have been treated with two or more prior lines of platinum based chemotherapy, and are unable to tolerate further platinum based chemotherapy.

The application for expanding Rubraca’s scope is based on data from the Phase III ARIEL3 clinical trial, which achieved both its primary and key secondary endpoints, extending progression-free survival (PFS) versus placebo in all patients treated, regardless of BRCA status.

Median PFS was found to be 10.8 months for the Rubraca treated group and 5.4 months for the placebo arm. In patients with a deleterious germline or somatic BRCA mutation, the figures were 16.6 months versus 5.4 months, respectively.

Clovis said it anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of 2018.

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