Clovis Oncology Inc (NASDAQ:CLVS) shares are trading sharply up in pre-market after a positive top line data from the confirmatory final stage ARIEL3 study of rucaparib that met primary endpoint of improved progression-free survival. The company indicated that the successful results came from the investigator review in every three populations studied.
Following this, Clovis Oncology indicated that it plans to submit a supplemental New Drug Application (sNDA) in the next four months for a second-line, as well as, later maintenance treatment indication. The drug candidate is for every woman affected by platinum-sensitive ovarian cancer and responded to their most recent therapy.
The company stated that the results reinforced the possible foundational role of rucaparib in the advanced ovarian cancer management and demonstrated by investigator review and the blinded independent central review. The company is looking forward to sharing the data in detail later this year at a medical meeting. The ultimate objective is to make recuparib available to every woman battling ovarian cancer.
Reacting to the development, professor and vice chair in the Gynecologic Oncology and Reproductive Medice, said, “The PFS and safety results achieved in this study are particularly promising, because they suggest women are able to stay on rucaparib for a prolonged period of time while gaining benefit. It is also clinically significant that rucaparib not only sustained the most recent response to platinum, but in some patients also enhanced that response, including the elimination of residual tumor.”
At time of writing this, Clovis Oncology shares jumped 45.91 percent in pre-market trading on Monday.