Strata Oncology will help Clovis Oncology accelerate patient enrollment in ongoing clinical trials assessing Clovis’ rucaparib as a treatment for metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA or ATM mutations.
Strata is conducting an observational study, the Strata Trial, which provides next-generation sequencing to all advanced cancer patients at affiliated cancer centers and hospitals. It refers patients with selected mutations to its pharmaceutical partners’ clinical trials.
Under the agreement with Clovis, Strata will refer prostate cancer patients with BRCA and ATM mutations to Clovis’s TRITON2 and TRITON3 clinical trials.
“We’re delighted to work with Clovis Oncology in advancing development of their highly promising drug rucaparib for prostate cancer patients,” Dan Rhodes, PhD, CEO of Strata Oncology, said in a press release. “We are confident that we will identify a number of mutant BRCA and ATM prostate cancer patients through the Strata Trial, and accelerate enrollment in the TRITON2 and TRITON3 clinical trials.”
The U.S. Federal Drug Administration has approved rucaparib under the brand name Rubraca as a therapy for patients with BRCA-mutated advanced ovarian cancer who have been treated with two or more chemotherapy regimens. But recent data suggests that the PARP inhibitor could also treat metastatic prostate cancers with BRCA or ATM mutations, or other mutations in DNA damage-repair genes. Metastatic cancers are those that have spread from the prostate to other parts of the body.
“Following rucaparib’s initial U.S. approval in ovarian cancer, we are committed to rapidly enrolling additional trials and expanding rucaparib development into broader indications, including prostate,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “Through our work with Strata, we seek to address the significant challenge of identifying and enrolling the right patients – in this case, patients with advanced prostate cancer who possess mutations of BRCA and/or ATM – in support of advancing our precision medicine clinical trials and potentially providing rucaparib to a broader population of patients.”
Both of Clovis’s clinical trials of rucaparib are enrolling participants.
The Phase 2 TRITON2 study (NCT02952534) is a multicenter, open-label, single-arm trial that will enroll 160 mCRPC patients who will be treated daily with oral rucaparib.
The Phase 3 TRITON3 trial (NCT02975934) will randomize 400 mCRPC patients to receive either oral rucaparib, Zytiga (abiraterone acetate), Xandi (enzalutamide) or Taxotere (docetaxel).
The new agreement will accelerate patient identification and enrollment in both trials.