NEW YORK (GenomeWeb) — Clovis Oncology said it is working with Strata Oncology to enroll a molecularly defined subset of advanced prostate cancer patients into its late stage TRITON clinical trials program for the PARP inhibitor Rubraca (rucaparib).
Last year, the US Food and Drug Administration approved Rubraca for advanced ovarian cancer patients who have received two or more prior chemotherapies and have BRCA1/2 mutations. The agency approved the drug alongside Foundation Medicine's FoundationFocus CDxBRCA, which is a next-generation sequencing test that gauges germline and somatic BRCA mutations.
Studies have shown that inhibition of PARP may also lead to anti-tumor effects in metastatic prostate cancer patients with mutations in BRCA1/2, ATM, and other DNA damage repair genes. Under the agreement with Clovis, Strata will refer castration-resistant prostate cancer patients with BRCA and ATM mutations for potential enrollment in Clovis' TRITON2 and TRITON 3 Rubraca studies.
As part of its own 100,000-patient observational study, Strata is providing free NGS testing to all advanced cancer patients at affiliated oncology centers and hospitals. Based on the mutations identified, Strata refers patients to ongoing clinical trials sponsored by its pharmaceutical partners.
"Through our work with Strata, we seek to address the significant challenge of identifying and enrolling the right patients … in support of advancing our precision medicine clinical trials and potentially providing rucaparib to a broader population of patients who may benefit," Clovis CEO Patrick Mahaffy said in a statement.