Amid bankruptcy, Clovis reveals more regulatory troubles for Rubraca

When it comes to PARP inhibitor Rubraca, Clovis Oncology is having a hard time executing on its plan.

Clovis’ bid to move Rubraca into earlier ovarian cancer treatment continues to face pushback from drug regulators. As the company navigates a bankruptcy process, that regulatory scrutiny could negatively affect the company’s search for a buyer for the drug.

The European Medicines Agency recently made “a number of requests” for more information around Clovis’ application for Rubraca as a first-line maintenance treatment in ovarian cancer patients who’ve responded to an initial round of chemotherapy, Clovis said in a securities filing (PDF) Monday. The company said it plans to provide the information in March.

In the U.S., the FDA previously said patient survival trends in a phase 3 trial suggest Rubraca may pose a potential harm for ovarian cancer patients in certain subgroups. The agency has asked for longer follow-up of the ATHENA-MONO trial to accrue 50% of patient deaths, but Clovis filed for approval anyway with the data at 25% maturity.

By Clovis’ estimates, the study may get to the 50% threshold in the first quarter of 2024. The FDA’s target decision date for the Rubraca application is June 25, 2023.

In Europe, the EMA also flagged the lack of mature overall survival data as the main limitation of Clovis’ filing. But based on Clovis’ disclosures, the EMA appears less demanding than the FDA, given that Clovis said that it’s able to provide the requested information by March.

Further, the EMA’s early assessment stated that the benefits of Rubraca in the front-line maintenance setting of ovarian cancer could be considered meaningful with a manageable safety profile, despite some uncertainties, according to Clovis.

The regulatory concerns spell trouble for Clovis’ efforts to find Rubraca a buyer as part of a bankruptcy process. The first-line maintenance ovarian cancer use is the most critical indication for PARP inhibitors, and increased use of AstraZeneca and Merck’s Lynparza and GSK’s Zejula in that setting has limited Rubraca’s potential in the market.

Clovis is “actively engaged in discussions with a number of interested parties” with respective to a potential Rubraca deal, the Colorado drugmaker said in the securities filing. As part of a court-approved bidding process, potential suitors have until March 21 to submit offers.

Separately, Clovis earlier reached a deal to sell its pipeline radiotherapy candidate FAP-2286 to Novartis for $50 million. That transaction is also open to bidding and requires approval by the bankruptcy court. The deadline to submit challenging bids is set for March 7.