Clovis Oncology Inc (NASDAQ: CLVS) shares rose after on word the company’s rucaparib ARIEL3 study met primary and secondary endpoints, and published today in The Lancet.
ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
CEO Patrick Mahaffy exulted, “The publication of the ARIEL3 data in this prestigious, peer-review journal reinforces the importance of identifying new therapies that provide meaningful clinical benefit to women with advanced ovarian cancer, and speaks to the high quality of the study design and the data we were able to deliver.
“We extend our sincere thanks to the study investigators and authors, as well as the many patients, who supported and participated in ARIEL3.”
Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a second line or later maintenance treatment indication in ovarian cancer by the end of next month.
Then, early next year, early 2018, CLVS plans to file a Marketing Authorization Application in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2016, rucaparib became the first PARP inhibitor approved by the FDA as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer.
Clovis shares gained 55 cents to $71.16, early Wednesday afternoon.
