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Clovis rockets on maintenance data in ovarian cancer

The US company plans to file ARIEL3 to the FDA within a few months

ClovisArmed with new data, Clovis Oncology will file for a maintenance indication for its PARP inhibitor Rubraca that will notch up its competitive profile, versing rival drugs from AstraZeneca and Tesaro.

The company's shares rocketed 46% on the announcement of the new clinical trial results for Rubraca (rupacarib) in second- line and later maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy, with Clovis suggesting it would file the data with the US FDA within the next four months.

If approved the new ARIEL3 data would give Rubraca the broadest label of any PARP inhibitor in ovarian cancer, leapfrogging AZ's first-to-market Lynparza (olaparib) and extending its lead over Tesaro's Zejula (niraparib), which was approved earlier this year. Rubraca was granted its first approval by the US FDA last December as a third-round therapy for BRCA-positive ovarian cancer.

In the latest study involving 564 women with ovarian, fallopian tube, or primary peritoneal cancer who had undergone platinum-based chemotherapy, patients on rucaparib had improved progression-free survival (PFS) - the trial's primary outcome measure.

Rubraca was associated with a PFS of 10.8 months versus 5.4 months for placebo, with benefits across all three patient groups analysed - those with BRCA mutations, a group with another genetic signature known as homologous recombination deficiency (HRD), and all-comers regardless of genetic status.

Leerink analysts said the data was a "best-case outcome" for the company, adding that the top-line figures "look particularly impressive when compared to previous competitor data and …should support a broad label for Rubraca in a broad [second-line] maintenance patient population".

They suggested the strong data could make Clovis an attractive target for acquisition, particularly as its market capitalisation is so much lower than Tesaro.

Meanwhile Morgan Stanley analysts concurred saying the data look similar to those for Zejula, which is already approved for all-comers as a maintenance therapy, while EP Vantage also suggested there was not much to choose between Rubraca and Lynparza in the maintenance setting.

The market for PARP inhibitors is expected to reach $8bn-$10bn at peak leaving plenty of room for all three products to develop into blockbuster brands, particularly if they can extend their indications into other indications such as breast cancer.

Another candidate - AbbVie's veliparib - failed two phase III trials in April (in breast and lung cancer) and now looks unlikely to challenge the leaders.

Article by
Phil Taylor

20th June 2017

From: Research



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