Shares of Clovis Oncology (NASDAQ:CLVS) opened more than 40% higher on Monday morning after the company announced positive results in a late-stage trial involving its Rubraca therapy—an outcome that could help widen the use of the drug and give Clovis a competitive edge.
Clovis said that Rubraca, an ovarian cancer drug, successfully slowed disease progression in patients with a variety of gene mutations who had already undergone therapy. Rubraca belongs to the exciting new group of oncology drugs called PARP inhibitors, which work by blocking enzymes involved in repairing damaged DNA.
In December, Rubraca was granted accelerated approval by the U.S. Food and Drug Administration for patients whose tumors have a BRCA mutation and whose disease has continued to develop despite multiple rounds of chemotherapy.
The new trial was intended to help Rubraca move up to a second-line treatment, making it useful for a longer period of time and effective for more types of patients. Clovis is expected to submit an application to expand the drug’s label within the next four months.
“These results reinforce the potentially foundational role of rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review,” said Clovis CEO Patrick J. Mahaffy. “We look forward to sharing these data in greater detail at a medical meeting later this year and submitting our sNDA as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer.”
Other new PARP inhibitors include Tesaro Inc.’s (NASDAQ:TSRO) Zejula and AstraZeneca’s (AX:ADR) Lynparza. Shares of both of these companies opened lower on Monday.
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