On October 4, 2022 Personalis, Inc. (Nasdaq: PSNL) reported that t has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer (Press release, Personalis, OCT 4, 2022, View Source [SID1234621692]). Specifically, the collaboration will focus on identifying composite biomarkers—those that integrate multiple biological entities into a single readout—to help guide therapeutic decision making.
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Gastroesophageal cancer is the fourth most common cancer worldwide, with nearly 50% of patients having developed unresectable or metastatic disease at the time of diagnosis. Chemotherapy is currently the standard of care for patients with this type of advanced disease; however, its effectiveness is often diminished as many patients develop therapeutic resistance. When this happens, the median overall survival for patients drops to less than 9 months.
Fortunately, pembrolizumab, an immunotherapeutic targeting PDL1/PD1, has been approved by the FDA for use in patients with chemorefractory gastroesophageal cancer. The effectiveness of this biologic has inspired significant interest in applying it as a first-line, standard of care treatment for patients with advanced disease.
To that end, the goal of the collaborative study is to characterize key tumor and immunological responses to pembrolizumab and, in so doing, shine light on the potential mechanisms that lead to either sensitivity or resistance to immunotherapeutics in gastroesophageal cancer. By detailing how tumors respond to treatment at the genomic, transcriptomic, and proteomic levels, the team aims to uncover biomarkers that may help physicians predict tumor responses to pembrolizumab and adjust treatment strategies accordingly.
"Biomarkers that predict and characterize tumor responses to anti-PDL1/PD1 therapy remain poorly understood, largely due to the complex and multifaceted interactions between the tumor and immune system. Through comprehensive plasma and tumor immune profiling, we aim to clarify the interconnected roles of tumor genomics and proteomics, as well as the development of composite biomarkers to clinically predict and follow immunotherapy response," said Andrew Nixon, PhD, Director of the Phase I Biomarker Laboratory, Duke University School of Medicine.
"This study has the potential to identify the mechanisms of immune resistance in metastatic gastroesophageal cancer, which may enable strategies to optimize response rates to existing immunotherapies and develop novel therapeutics that overcome resistance," said Marijana Rucevic, PhD, Senior Scientific Director, Olink Proteomics. "We are honored to participate in this essential and exciting research effort with Duke and Personalis, and to further direct the strengths of Olink’s PEA technology against the growing challenge of cancer drug development and personalized cancer treatment."
"We believe the clinical management of cancer can substantially improve with early determination of patient response and by accurately informing changes to treatment regimens. Such determinations offer the potential to avoid unnecessary toxicities and increase survival," said Dr. Richard Chen, MD, Chief Medical Officer and Senior Vice President of R&D at Personalis. "By collaborating with researchers at Duke and Olink, we hope to accelerate advances in oncology practice via ultra-sensitive MRD detection."
Personalis’ ImmunoID NeXT Platform will be used for characterization of tumor genomic and transcriptomic alterations, as well as differences between responders and non-responders. Additionally, Personalis’ NeXT Personal assay will be used to analyze circulating tumor DNA (ctDNA) collected from patients in order to profile and accurately track molecular residual disease (MRD) over the course of therapy. Olink Explore panels will be used to analyze plasma samples and tumor tissues from metastatic gastroesophageal cancer patients being treated with anti-PD1 and anti-PD1/chemotherapy.
About NeXT Personal
NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.