Gilead Sciences has collaborated with Strata Oncology to provide Trodelvy (Sacituzumab govitecan-hziy) for eligible cancer patients in the Strata Precision Indications for Approved THerapies (Strata PATH) trial.
The 700-patient, prospective pan-tumour therapeutic Strata PATH trial will assess the safety and efficacy of several cancer therapies approved by the US Food and Drug Administration (FDA) in new, biomarker-guided patients.
Several biomarker types are being evaluated, which include quantitative RNA and multivariate algorithms, expected to optimise the use of various anti-cancer therapies.
Strata Oncology developed these algorithms using its clinical molecular database that consists of DNA mutation profiles and quantitative RNA expression data.
Parallelly, these biomarkers can be analysed with the genomic mutations that are evaluated by comprehensive genomic profiling (CGP), thereby increasing the information available from samples of tumour tissues that are often limited.
Strata Oncology CEO and co-founder Dan Rhodes said: “As the first diagnostics company to run its own prospective interventional trial to show the utility of its tests, Strata is honoured to have the support and collaboration of forward-thinking biopharma companies like Gilead Sciences for the Strata PATH trial.
“Quantitative RNA and multivariate biomarkers have the potential to optimise the use of expression-based therapies and improve the outcomes and the quality of life for cancer patients.”
The Strata PATH trial will include advanced cancer patients and those with early-stage cancer who have evidence of micrometastatic disease, following initial treatment.
All therapies that are being evaluated in this trial are approved by the FDA in oncology and demonstrated safety profiles in the advanced setting.
In May last year, the FDA lifted the clinical hold on Gilead Sciences’ Investigational New Drug Application (IND) of injectable lenacapavir for treating and preventing human immunodeficiency virus infection (HIV).