In a major win for Clovis Oncology, the European Commission (EC) has granted approval for an expanded indication for its cancer drug, Rubraca (rucaparib). This approval allows the PARP inhibitor to be used as a maintenance treatment for adult women with relapsed ovarian cancer, offering new hope for patients battling this challenging disease. The decision is based on data from the pivotal ARIEL3 clinical trial, which demonstrated the drug’s significant effectiveness in prolonging progression-free survival in patients with platinum-sensitive high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Groundbreaking approval provides new option for ovarian cancer patients

The EC’s approval of Rubraca for maintenance therapy is a critical step in enhancing treatment options for women who have experienced a relapse of their ovarian cancer. The approval applies to women whose cancers have responded either completely or partially to platinum-based chemotherapy. This new indication marks a significant milestone, following Rubraca’s initial approval in Europe in May 2018 for the treatment of recurrent ovarian cancer as monotherapy.

The approval stems from the results of the ARIEL3 trial, which involved 564 patients with recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer, all of whom had shown a complete or partial response to platinum-based chemotherapy. The trial demonstrated that rucaparib significantly extended progression-free survival (PFS) compared to placebo, with impressive results across all patient groups, irrespective of their BRCA mutation status.

ARIEL3 trial results drive EC approval for Rubraca

The ARIEL3 clinical trial was a randomised, double-blind, placebo-controlled study that tested the efficacy of rucaparib in a population of women with relapsed ovarian cancer. Participants were assigned to receive either 600mg of rucaparib twice daily or a placebo. The primary endpoint of the trial, which was to demonstrate an improvement in progression-free survival, was met, showing that Rubraca could delay the progression of the disease more effectively than a placebo. Additionally, the trial achieved the key secondary endpoint of further prolonging PFS, further solidifying Rubraca’s clinical value.

CEO’s statement on Rubraca’s impact on ovarian cancer treatment

Patrick J. Mahaffy, President and CEO of Clovis Oncology, expressed his enthusiasm for the EC approval, highlighting its importance in expanding access to maintenance treatment for women with platinum-sensitive ovarian cancer. He stated, “This EC authorization of rucaparib is an important step in ensuring that it is available to all women who may potentially benefit, regardless of their BRCA status. We believe that access to maintenance treatment is extremely important for women with relapsed platinum-sensitive ovarian cancer, and we are pleased that rucaparib can now be an option for these women.”

He also emphasized Rubraca’s unique position in the market, noting that it is the only PARP inhibitor to show both further tumor shrinkage and prolonged progression-free survival in the maintenance setting for ovarian cancer. Mahaffy added that the approval represents a major advancement in treatment for women suffering from advanced ovarian cancer.

Rubraca’s broader potential in oncology treatments

Beyond its use in ovarian cancer, rucaparib is being studied for other malignancies, including metastatic castration-resistant prostate cancer and bladder cancer. As an oral small molecule inhibitor of the PARP1, PARP2, and PARP3 enzymes, Rubraca works by blocking cancer cells’ ability to repair DNA damage, leading to cell death. It is currently being evaluated both as a monotherapy and in combination with other anti-cancer therapies, reinforcing its broad potential in oncology.

With this new EC approval, Clovis Oncology’s Rubraca is poised to become a critical tool in the fight against relapsed ovarian cancer, providing patients with a vital maintenance therapy option that could significantly improve their quality of life and survival outcomes.

  ARIEL3 trial, Clovis Oncology, European Commission, Ovarian Cancer, PARP inhibitor, platinum-sensitive cancer, Progression-Free Survival, Rubraca, rucaparib