Rucaparib Clinical Data from AACR Virtual Annual Meeting 2021

April 13, 2021
Jill Murphy, Associate Editor

The safety profile was consistent with the profiles associated with each drug as a monotherapy, with no clinically significant drug-drug interactions observed with the combination.

Findings from the phase 1b RAMP study evaluating the combination of rucaparib (Rubraca) and enzalutamide (Xtandi) in men with unselected metastatic castration-resistant prostate cancer (mCRPC) lay the groundwork for the phase 3 CASPAR study, which is expected to begin enrolling patients shortly, according to a Clovis Oncology press release.

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2, and PARP3 that is being developed in multiple tumor types, including ovarian cancer and mCRPC as a monotherapy and in combination with other anti-cancer agents, according to the press release.

Phase 1 data from the RUCA-J study of rucaparib in Japanese patients with advanced solid tumors show similar safety and pharmacokinetic profiles to those observed in Western patients, according to data being presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting, held from April 10 to April 15, 2021.

"We remain committed to understanding how Rubraca may benefit patients with cancer, and the data presented at AACR further enhance our understanding in different patient populations and solid tumor types," said Patrick J. Mahaffy, president and CEO of Clovis Oncology, in the press release. "The Phase 1b RAMP data for the combination of Rubraca and Xtandi in unselected mCRPC patients help inform the Alliance for Clinical Oncology-sponsored CASPAR Phase 3 trial which is expected to begin enrolling patients soon, and we look forward to learning more about the combination."

In the poster “Genomic Characteristics and Response to Rucaparib and Enzalutamide in the Phase 1b RAMP Study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients” from the AACR 2021 meeting, the results demonstrated that unselected patients with mCRPC who had progressed on androgen receptor (AR)-directed therapies reported declines in prostate-specific antigen levels following treatment with a combination of rucaparib 600 mg twice daily and enzalutamide 160 mg once daily. Additionally, these declines were observed even in the presence of AR alterations and the absence of DNA damage repair gene alterations.

The safety profile was consistent with the profiles associated with each drug as a monotherapy, with no clinically significant drug-drug interactions observed with the combination.

The poster “Evaluation of Rucaparib in Japanese Patients with a Previously Treated Advanced Solid Tumor” outlines that rucaparib 600 mg taken twice daily had a manageable safety profile for Japanese patients with advanced solid tumors, including ovarian, prostate, endometrial, and pancreatic cancers. The pharmacokinetic profile of rucaparib in Japanese patients overlapped with that of Western patients, according to the poster. Among patients with measurable disease, 18.5% achieved an objective response rate and 51.9% had stable disease per RECIST v1.1. These results support further exploration of rucaparib 600 mg twice daily in Japanese patients, according to the researchers.

REFERENCE

Clovis Oncology Highlights Rubraca® (rucaparib) Clinical Data at AACR Virtual Annual Meeting 2021. Published April 10, 2021. Accessed April 12, 2021. https://finance.yahoo.com/news/clovis-oncology-highlights-rubraca-rucaparib-123000334.html