Results from the TRANSFAL study - a molecular sub-study derived from the MEDSIR-sponsored PARSIFAL clinical trial (NCT02491983) - were presented at ESMO 2020.
The PARSIFAL trial was an international, multicenter, randomized, open-label phase II study that explored the optimal endocrine agent to combine with palbociclib as initial therapy for patients with endocrine-sensitive, ER[+]/HER2[-] advanced breast cancer (ABC). MEDSIR collected and established a unique serial specimen biorepository of palbociclib first line-treated patients from the PARSIFAL trial which is instrumental for biomarker studies and future analyses if novel hypothesis and/or technologies become available in the future.
The TRANSFAL is an exploratory and comprehensive study created with the main goal to analyze the molecular tumor profile of patients enrolled in the PARSIFAL trial, in an attempt to answer the urgent need for predictive and prognostic biomarkers of response to palbociclib. To achieve its aims, TRANSFAL explores different approaches for biomarker studies including DNA and mRNA sequencing and proteomics using tumor tissue, and ctDNA analyses using liquid biopsy samples. The TRANSFAL trial also includes in vivo studies to develop new animal models of the disease.
Last Friday 18th of September, Dr. Marta Palafox from the team of Dr Violeta Serra at the Vall d’Hebron Institute of Oncology in Barcelona, presented the first results of the in vivo work. The team established luminal breast cancer patient-derived xenografts (PDX) models from a group of patients from the PARSIFAL trial, with the aim to develop preclinical models that can recapitulate the disease before and after treatment.
In last week’s presentation, Dr. Palafox summarized results of 3 successfully established tumor engraftments. Xenografts were profiled using a capture-based exome sequencing panel and characterized by immunohistochemistry as well as for the in vivo anti-proliferative activity of palbociclib plus the patient-matched ET. The models developed by scientists at Dr Serra’s laboratory demonstrate translational co-studies associated to clinical trials are feasible despite of the low tumor take-rate and resemble the patient’s clinical response to CDK4/6 inhibitors plus ET.
“Co-clinical patient-derived tumor models enable the study of predictive response biomarkers and mechanisms of resistance to drugs, as well as allowing scientists to propose therapeutic strategies for the context of resistance. Our in vivo experiments unveiled that PDX models resembled the molecular subtype and the genetic profile of the original tumors and responded to treatment in a similar way patients did in the clinic.” – said Dr Palafox.
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