In early trading, Monday, Clovis Oncology Inc. (NASDAQ: CLVS) jumped 16.96% to $1.35 after encouraging results from the analysis. Stock prices for CLVS traded between $1.10 and $1.16 in the last trading session, gaining 4.55%.
What CLVS has shared?
Earlier today, Clovis Oncology (CLVS) announced that it had completed a subgroup analysis of its phase 3 ATHENA trial, which compared monotherapy to chemotherapy (ATHENA-MONO). Surgical outcome, first-line chemotherapy response, and other analyses showed Rubraca to be superior to placebo for progression-free survival (PFS) in multiple disease risk groups.
As part of the European Society of Medical Oncology (ESMO) Congress 2022, Rebecca S. Kristeleit, MD, Ph.D., lead investigator at the ATHENA trial for ENGOT/NCRI National Cancer Research Institute, presented an abstract of the data. Kristeleit is a physician and doctorate from Guy’s and St. Thomas’ NHS Foundation Trust in London.
An ATHENA study is testing Rubraca in Phase 3 double-blind, placebo-controlled trials. The data is divided into two independent parts statistically. The results from ATHENA-MONO will be presented at ESMO, while the results from ATHENA-COMBO will be presented in Q1 2023.
ATHENO-MONO further supports Rubraca’s potential as a first-line maintenance therapy for women with advanced ovarian cancer, according to CLVS President and CEO Patrick J. Mahaffy. Those who participated in the human trial, as well as the clinical community who knows about the findings, deserve our gratitude.
A total of 538 women with high-grade ovarian and peritoneal cancers were enrolled in the ATHENA-MONO study. Two molecular subgroups were evaluated sequentially as part of the primary efficacy analysis. In the first study, CLVS investigated patients with homologous recombination deficiency (HRD), which includes BRCAm tumors and BRCAwt/LOH high tumors. Those randomized in ATHENA-MONO comprised the second subgroup.
What impact does this have on CLVS?
Clovis Oncology’s (CLVS) ATHENA-MONO analysis of the Phase 3 ATHENA trial strongly supports the use of rucaparib for first-line maintenance treatment of women with advanced ovarian cancer. As a result of this analysis, CLVS’ rucaparib was found to prolong progression-free survival regardless of molecular characteristics in patients with or without high progression risk factors. This further demonstrates that rucaparib is effective in the broadest population of patients assessed for first-line PARP inhibitor monotherapy.