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.

Ovarian Cancer

For rucaparib approved or authorized uses click here.

Rucaparib in patients with ovarian cancer study completed enrollment.

  • The pivotal Phase 3 ATHENA study in first-line maintenance treatment study to evaluate rucaparib + nivolumab, rucaparib, nivolumab and placebo in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer who have completed platinum-based chemotherapy. In June 2020, the company announced the completion of enrollment of 1000 patients in the Clovis-sponsored Phase 3 ATHENA trial evaluating rucaparib as monotherapy and the combination of rucaparib and nivolumab as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. This Clovis sponsored study is part of a broad clinical collaboration with Bristol Myers Squibb.

Prostate Cancer

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 is open for 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.

Other Studies

The Phase 2 LODESTAR study is a pan-tumor study in patients with solid tumors associated with deleterious mutations in homologous recombination repair genes is open for enrollment.

Exploratory studies in other tumor types are also underway. 

Rucaparib Scientific Presentations 

Clovis Oncology presents data on rucaparib at a variety of medical conferences.

Analysis of Patients Who Derived Exceptional Benefit From Rucaparib Maintenance Treatment for High-grade Ovarian Cancer in the Phase 3 ARIEL3 Study

Oral Presentation 2021 ESGO Hybrid Meeting

Clinical and Molecular Characteristics of ARIEL3 Patients Who Derived Exceptional Benefit from Rucaparib Maintenance Treatment for High-Grade Ovarian Cancer (HGOC)

Poster Presentation 2021 ASCO Virtual Annual Meeting

Phase 1b/2 SEASTAR Trial: Safety, Pharmacokinetics, and Preliminary Efficacy of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Rucaparib and Angiogenesis Inhibitor Lucitanib in Patients with Advanced Solid Tumors

Poster Presentation 2021 ASCO Virtual Annual Meeting

Subgroup Analysis of Rucaparib Versus Chemotherapy as Treatment for BRCA-mutated, Advanced, Relapsed Ovarian Carcinoma: Effect of Platinum Sensitivity in the Randomized, Phase 3 Study ARIEL4

Poster Presentation 2021 ASCO Virtual Annual Meeting

Evaluation of Rucaparib in Japanese Patients with a Previously Treated Advanced Solid Tumor

Poster Presentation 2021 AACR Virtual Annual Meeting

Genomic Characteristics and Response to Rucaparib and Enzalutamide in the Phase 1b RAMP Study of Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients

Poster Presentation 2021 AACR Virtual Annual Meeting

Rucaparib vs Chemotherapy in Patients With Advanced, Relapsed Ovarian Cancer and a Deleterious BRCA Mutation: Efficacy and Safety From ARIEL4, a Randomized Phase 3 Study

Virtual Presentation 2021 SGO Virtual Meeting

Association of Co-Occurring Gene Alterations and Clinical Activity of Rucaparib in Patients With BRCA1- or BRCA2-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Poster Presentation 2021 ASCO GU Virtual Meeting

Rucaparib + Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Pharmacokinetics (PK) and Safety Data From the Phase 1b RAMP Study

Poster Presentation 2021 ASCO GU Virtual Meeting