Janssen has tapped Resolution Bioscience to help develop a companion liquid biopsy test for the PARP inhibitor Zejula (niraparib) in patients with metastatic castration-resistant prostate cancer.
Resolution’s cell-free DNA assay is currently being used in Zejula’s phase 2 and 3 development against the disease to detect homologous recombination deficiency mutations and gene deletions.
The blood test was granted a breakthrough device designation by the FDA this past May. If approved, Resolution said it could be the first in vitro diagnostic to detect gene deletions from cell-free DNA and identify both single-copy and biallelic gene deletions.
Additionally, the Kirkland, Washington-based company said it expects the test will help identify more men seeking targeted therapies such as Zejula, especially late-stage patients from which tissue for a biopsy can be difficult to collect.
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In February, Janssen presented data from an open-label phase 2 study of Zejula demonstrating an objective response rate of about 40% in patients with metastatic castration-resistant prostate cancer and DNA-repair pathway defects including BRCA1 and BRCA2.
"It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15% and a median progression-free survival of three months with currently available therapies," Janssen’s vice president of clinical development in prostate cancer Margaret Yu said at the time.
"Given these results, prospective biomarker testing could enable healthcare professionals to personalize therapy for patients with metastatic castration-resistant prostate cancer in the future," Yu said. In the study, patients tested positive for a repair pathway mutation in one of eight genes.
Previously approved in ovarian cancer, Janssen picked up the worldwide rights outside of Japan for Zejula in prostate cancer from Tesaro in April 2016.
Separately, Janssen announced a data science research collaboration with the University of California, San Francisco and UC Berkeley offering a Bay Area fellowship program run by the universities and working with the product and platform teams within the Johnson & Johnson pharmaceutical arm.
Projects could include artificial intelligence-driven apps for spotting the early warning signs of disease or new methods of recruiting participants for clinical trials, according to Janssen. The agreement is part of a broader arrangement for sponsored research among the universities and Johnson & Johnson’s medical devices and consumer-focused companies, as well.