Clovis Oncology Reports Positive Top-Line Trial Data
Mar 31, 2022 By MarketDepth
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive top-line data from the monotherapy arm of the ATHENA trial.
Achieved Primary Endpoint
The data demonstrates that the company’s oral, small molecule inhibitor of PARP1, PARP2 and PARP3, Rubraca had successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo, improving progression-free survival in first-line maintenance treatment in women with ovarian cancer.
“The results from the ATHENA-MONO study of Rubraca in first-line maintenance treatment ovarian cancer exceeded our expectations in terms of significant improvement in PFS versus placebo in each of the primary efficacy populations, including the all-comers or intent-to-treat population.”Patrick J. Mahaffy, President and CEO of Clovis Oncology
Furthermore, the safety of Rubraca observed in ATHENA-MONO was consistent with both the current U.S. and European labels. The company now intends to use these findings to submit a supplemental New Drug Application (sNDA) to the U.S. FDA during the second quarter of 2022 followed by a Type II Variation to the EMA during the third quarter of 2022.
“We believe that the positive results from ATHENA-MONO demonstrate that Rubraca will provide an important new treatment option for women with advanced ovarian cancer in the first-line maintenance setting, and we look forward to submitting these data to the regulatory authorities in the US and Europe during Q2 and Q3 2022, respectively.”Mr. Mahaffy, President and CEO of Clovis Oncology