Clovis plots Rubraca label expansion with new phase 3 data for its PARP inhibitor

Clovis Oncology reported that its Rubraca met primary and secondary endpoints in a new phase 3 trial.

Just months into the launch of its PARP inhibitor Rubraca, Clovis Oncology on Monday unveiled positive phase 3 results that the drugmaker hopes can win its ovarian cancer drug a big label expansion in its three-drug horse race with AstraZeneca’s Lynparza and Tesaro’s Zejula.

In a phase 3 study dubbed Ariel3, Rubraca improved progression-free survival for each of three patient populations studied, meeting primary and secondary endpoints in the 564-patient trial. For the primary endpoint, investigators analyzed women with the BRCA mutation, HRD-positive patients and the entire study population. Rubraca significantly bested placebo for each of the groups.

Clovis plans to submit its data to the FDA within four months, aiming for an expansion into second-line and later maintenance treatment for ovarian cancer patients. Currently, Rubraca is approved to treat ovarian cancer patients who have the BRCA gene mutation and who’ve already had two or more chemotherapies.

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In a Monday note to clients, Leerink analyst Michael Schmidt said the results are a “best-case-scenario” for Clovis, adding that they “should support a broad label for Rubraca in a broad” second-line maintenance patient population, “independent of BRCA/HRD status and testing.”

Once Clovis submits the new data, the FDA’s review will take up to six months, executives told analysts on a Monday conference call. The company’s shares jumped 47% on Monday’s news.

Rubraca won approval last year in a class of drugs that now includes AstraZeneca’s Lynparza and Tesaro’s Zejula. Zejula is already approved in the maintenance treatment setting, while AstraZeneca is pushing for the indication with Lynparza.

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When Rubraca won U.S. approval back in December, Clovis announced a price of $6,870 for a 15-day supply, or $13,740 for a month. The launch is now underway and Clovis reported $7 million in sales for the first quarter with the new entrant.

Rubraca is also under review in Europe and Clovis is setting up an organization there to support a potential launch early next year.

AstraZeneca was the first to reach the market with a PARP inhibitor, winning approval for Lynparza back in late 2014. Abbvie and Pfizer each have PARP candidates in their respective pipelines. Tesaro’s price for Zejula, which won approval back in March, is $9,833 for a month, while AstraZeneca’s Lynparza is $12,450 per month.