Clovis Oncology Highlights Rubraca (rucaparib) Clinical Data at AACR Virtual Annual Meeting 2021 - Seite 2

• Lead author: Kenji Tamura, MD, PhD, National Cancer Center Hospital, Tokyo, Japan
• Session: Phase I Clinical Trials
• Date/Time: April 10, 2021, 8:30 a.m. - 11:59 p.m. ET
• Key Takeaways: This study suggests rucaparib 600 mg taken twice daily had a manageable safety profile for Japanese patients with advanced solid tumors, including ovarian, prostate, endometrial, and pancreatic cancer. The pharmacokinetic profile of rucaparib in Japanese patients overlapped with that of Western patients. Among patients with measurable disease, 18.5% (5/27) achieved an objective response rate and 51.9% (14/27) had stable disease per RECIST v1.1. These results support further exploration of rucaparib 600 mg twice daily in Japanese patients.

The presentations can also be viewed at https://www.clovisoncology.com/pipeline/scientificpresentations/ .

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Ovarian Cancer

Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Prostate Cancer

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Patients should be identified for treatment with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.