On February 1, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. reported an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment (Press release, Clovis Oncology, FEB 1, 2017, View Source [SID1234517614]).

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Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca (rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).

Strata Oncology is conducting the Strata Trial, an observational study that provides next-generation sequencing at no cost to all advanced cancer patients at its affiliated cancer centers and hospitals. Strata then refers patients with selected mutations to physicians involved in its pharmaceutical partners’ targeted clinical trials. Strata seeks to fulfill the promise of precision medicine by improving the number of patients identified with specific mutations appropriate for ongoing clinical trials.

Under the terms of the agreement, Strata will exclusively refer BRCA and ATM-mutated advanced prostate cancer patients for consideration of enrollment to Clovis’ TRITON2 and TRITON3 clinical trials of rucaparib. The Strata Trial is available at an expanding network of select cancer centers and hospitals nationwide.

"We’re delighted to work with Clovis Oncology in advancing development of their highly promising drug rucaparib for prostate cancer patients," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "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."

"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 who may benefit."