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PROPHETIC Study of Immunotherapy Diagnostic Adds New Site in Buffalo, NY

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The PROPHETIC trial of a predictive diagnostic analysis platform expanded to a new site at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

Roswell Park Comprehensive Cancer Center will be joining the investigation of OncoHost’s PROphet precision oncology analysis platform and launching a clinical site in Buffalo, New York, according to a press release from OncoHost.1

The PROphet platform’s purpose is to predict response to immunotherapy treatment through proteomic analysis of a blood sample. Roswell Park Comprehensive Cancer Center will use PROphet to conduct analysis of patients receiving immunotherapy for late-stage malignant melanoma, small cell lung cancer (SCLC), and non–small cell lung cancer (NSCLC).

“Roswell Park is proud to help advance this work with our participation as a study site,” Igor Puzanov, MD, MSCI, professor of medicine and oncology at Roswell Park Comprehensive Cancer Center and principal investigator of the study, said in a statement. “We look forward to exploring the study’s ongoing development and eventual findings, with the hope of improving our patient outcomes as a result.”

The goal of the ongoing multicenter PROPHETIC study (NCT04056247) is to develop an algorithm for predicting treatment outcome based on blood plasma analysis. The trial plans to enroll approximately 2000 participants in 37 clinical sites in the United States, Israel, and the United Kingdom.

The PROphet diagnostic system scans approximately 7000 proteins in a patient’s plasma using the SomaScan platform, then uses bioinformatic and machine learning-based algorithms to predict patient outcomes based on proteomic patterns as well as identifying potential drug targets.2 Interim results of the PROPHETIC trial showed that analysis of a single blood test could predict response to immunotherapy treatment for NSCLC with high accuracy at 3 months, 6 months, and 1 year.

“With an increase in available treatment options, oncologists and patients find themselves facing a challenge in how to successfully identify treatment approaches that will yield the highest success probability,” said Puzanov. “To maximize the likelihood of selecting the correct therapy combinations for each patient, clinicians rely on predictive biomarkers to guide individual treatment planning.”

A previous study that was presented at the 2020 American Society of Clinical Oncology Annual Meeting identified a 10-protein signature that distinguished between patients with or without response to anti­–PD-1 and anti–CTLA-4 immunotherapy for advanced melanoma.3 These results are being validated by the PROPHETIC study.

The PROPHETIC trial’s first part will develop the prediction algorithm based on blood samples and medical records of patients, and in the second part, the patients’ objective response rate will be compared with the predicted response from the algorithm to determine whether the predicted response matches the clinically-observed outcome at 3 and 6 months after therapy.

The study aims to provide more data to support PROphet’s planned commercial launch in the United States later in 2022, according to the press release.1

”We are excited to partner with a prestigious and leading provider of cancer treatment, collaborating to gain a better understanding of patient response,” Ofer Sharon, MD, CEO of OncoHost, said in a statement. “With Roswell Park joining our multicenter trial we can now expand recruitment, further developing our research base and improving on our current technology capabilities. We anticipate strong results from this study, which will eventually help us provide a premier tool for oncologists and physicians in the fight against cancer.”

References:

1. OncoHost announces clinical trial collaboration with Roswell Park Comprehensive Cancer Center to analyze immunotherapy resistance. PR Newswire. April 5, 2022. Accessed April 6, 2022. https://prn.to/3jaf90z

2. OncoHost announces interim results from prophetic trial, multicenter assessment of NSCLC patient response to immunotherapy. PR Newswire. January 12, 2022. Accessed April 6, 2022. https://prn.to/3jcKsba

3. Shaked Y, Harel M, Issler E, et al. A proteomic biomarker discovery platform for predicting clinical benefit of immunotherapy in advanced melanoma. J Clin Oncol. 2020;38(15_suppl):10037-10037. doi:10.1200/JCO.2020.38.15_suppl.10037

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