Rucaparib Clinical Development Overview
Rucaparib is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Clovis holds global rights for rucaparib.
Rucaparib in patients with ovarian cancer study completed enrollment.
- The pivotal Phase 3 ATHENA study in first-line maintenance treatment study to evaluate rucaparib in combination with nivolumab in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer who have completed platinum-based chemotherapy. The 1000 patient study will provide data from two independent readouts: rucaparib monotherapy versus placebo (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO). This Clovis sponsored study is part of an ongoing clinical collaboration with Bristol Myers Squibb.
Rucaparib is in clinical development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients.
- Rucaparib is being studied in the Phase 3 TRITON3 trial for patients with BRCA mutations and ATM mutations who have progressed on AR-targeted therapy and who have not yet received chemo in the castrate-resistant setting. This trial has completed enrollment.
- The Phase 3 CASPAR study is evaluating the benefit of adding rucaparib to enzalutamide for men with mCRPC that has become resistant to testosterone-deprivation therapy. This trial is open for enrollment and is sponsored by the Alliance for Clinical Trials in Oncology which is part of the National Cancer Institute.
Exploratory studies in other tumor types are also underway.
Rucaparib Scientific Presentations
Clovis Oncology presents data on rucaparib at a variety of medical conferences.
TRITON3: A Phase 3 Study of Rucaparib vs Physician’s Choice of Therapy in Metastatic Castration-Resistant Prostate Cancer Associated with Homologous Recombination Deficiency
Oral Presentation 2022 PCF Annual Retreat
Overall Survival Results From ARIEL3: A Phase 3 Randomised, Double-blind Study of Rucaparib vs Placebo Following Response to Platinum-Based Chemotherapy for Recurrent Ovarian Carcinoma
Oral Presentation 2022 ESGO Congress
Real-world Progression-Free Survival and Overall Survival for Patients With Advanced Ovarian Cancer Utilizing PARP Inhibitor Second-line Maintenance Therapy vs Active Surveillance
ePoster Presentation 2022 IGCS Annual Global Meeting
Overall Survival Results From ARIEL3: A Phase 3 Randomized, Double-blind Study of Rucaparib vs Placebo Following Response to Platinum-Based Chemotherapy for Recurrent Ovarian Carcinoma
Oral Presentation 2022 IGCS Annual Global Meeting
Rucaparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer: Defining Benefit According to Disease Risk Subgroups Within the Phase 3 ATHENA–MONO Study
Oral Presentation 2022 ESMO Congress
Overall Survival Results From ARIEL4: A Phase 3 Study Assessing Rucaparib vs Chemotherapy in Patients With Advanced, Relapsed Ovarian Carcinoma and a Deleterious <i>BRCA1/2</i> Mutation
Oral Presentation 2022 ESMO Congress
ATHENA–MONO (GOG-3020/ENGOT-ov45): A Randomized, Double-blind, Phase 3 Trial Evaluating Rucaparib Monotherapy Vs Placebo As Maintenance Treatment Following Response to First-line Platinum-based Chemotherapy In Ovarian Cancer
Oral Presentation 2022 ASCO Annual Meeting
Efficacy and Safety of Rucaparib Maintenance Treatment in Patients From ARIEL3 With Platinum-Sensitive, Recurrent Ovarian Carcinoma Not Associated With Homologous Recombination Deficiency
Poster Presentation 2022 ASCO Annual Meeting
Nonclinical Evaluation of Rucaparib in Tumors with Mutations in Non-<i>BRCA1/2</i> Homologous Recombination Repair (HRR) genes
Poster Presentation 2022 AACR Annual Meeting
Duration of Treatment, Treatment Adherence, and Treatment Discontinuations Associated with Second-line PARP Inhibitor or Bevacizumab Maintenance Regimens for Recurrent Ovarian Cancer
Poster Presentation 2022 SGO Annual Meeting