Rubraca (rucaparib) is now available in France and eligible for reimbursement when used as a maintenance therapy by women with relapsed ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA status, its developer, Clovis Oncology, announced.
“Rubraca is effective across a broad population of women with relapsed ovarian cancer and is an important step in the ovarian cancer treatment pathway for eligible patients,” Patrick J. Mahaffy, the company’s president and chief executive officer, said in a press release.
Its reimbursement under the French public health system, together with availability, make it “a new treatment for patients with platinum-sensitive relapsed ovarian cancer,” added Anne Floquet, president of the SFOG, the French Society for Gyneco-Oncology.
The oral treatment is a PARP inhibitor that works by blocking the activity of PARP enzymes that are responsible for repairing DNA in cells. By blocking the activity of these enzymes, Rubraca prevents cancer cells from repairing their DNA, ultimately destroying them.
PARP inhibitors are particularly effective in cancer cells harboring defects in other DNA repair mechanisms, including those with mutations in the BRCA1 and BRCA2 tumor-suppressor genes, due to their reliance on PARP to survive and grow.
The presence of these mutations has been associated with better treatment responses, likely due to a larger number of potential therapies. But most patients without BRCA mutations typically have a worse prognosis and fewer treatment options.
“The availability of rucaparib is good news, as ovarian cancer is a disease often diagnosed at an advanced stage and many women may have a poor prognosis,” said Isabelle Ray-Coquard, president of the GINECO group, which specializes in women’s cancers and coordinates clinical trials in France and abroad.
“Patients with relapsed ovarian cancer may have many debilitating symptoms, and it is important that new treatments such as rucaparib are made available to the eligible patients that may benefit from them,” Ray-Coquard said.
Rubraca was initially approved as a treatment for women with BRCA-mutated advanced ovarian cancer, first in the U.S., and then in the European Union.
Its indication was then extended in the U.S., and in the European Union, to include its use as maintenance treatment for women with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA status. These approvals covered patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The approval of Rubraca’s second indication was based on positive data from a Phase 3 trial (NCT01968213) called ARIEL3, which evaluated Rubraca as a maintenance therapy in 564 women with recurrent ovarian cancer who had responded to platinum-based chemotherapy compared to a placebo.
A total 375 women were treated with Rubraca and 189 received a placebo, both administered orally, at a dose of 600 mg twice a day.
Findings showed that Rubraca significantly extended the time women lived without signs of disease progression, from 5.4 months to 10.8 months, reducing the risk of disease progression or death by 64% and meeting the trial’s main objective.
Data from an independent radiological review indicated that Rubraca treatment extended patients’ disease-free survival even further, reaching a median of 13.7 months.
This survival benefit was seen in the overall population, regardless of BRCA status. But in women with BRCA mutations, Rubraca led to better responses, delaying disease progression from 5.4 months to 16.6 months.
Treatment was found to be safe and well-tolerated, with most adverse events being mild to moderate in severity. Fatigue and physical weakness, vomiting, anemia, and abdominal pain were among the most common side effects reported.
“I am very proud to have been able to participate in the ARIEL3 study, which demonstrates the effectiveness of rucaparib in improving patients’ progression-free survival. I am also delighted to be able to prescribe this treatment as it may offer benefits for eligible patients,” Floquet, with SFOG, said.
“We are working to make Rubraca available in multiple countries across Europe, and with the reimbursement and availability of Rubraca in France, it is now a treatment option for eligible patients in Germany, England, Italy, and in France,” Mahaffy added.
Italy recently agreed to reimburse eligible patients prescribed Rubraca, bringing the treatment into its public health program in November 2019.