On September 12, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported new biomarker data suggesting the Xerna TME Panel has predictive and prognostic potential in esophagogastric adenocarcinoma (Press release, OncXerna Therapeutics, SEP 12, 2022, View Source [SID1234619399]). The data are featured in a poster being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The data featured in the ESMO (Free ESMO Whitepaper) poster are from retrospective analyses of results from PLATFORM, a randomized Phase 2 trial that evaluated maintenance therapies such as the anti-PD-1 antibody durvalumab in esophagogastric adenocarcinoma patients treated with first-line chemotherapy. Analyses were performed using the Xerna TME Panel, a novel RNA gene expression-based diagnostic panel that uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME).

Using the Xerna TME Panel, researchers analyzed pre-treatment tumor biopsies to classify patients who went on to receive durvalumab maintenance therapy or active surveillance only as immune score "high" or immune score "low." These classifications were compared against clinical outcomes recorded in the trial. Results showed that immune score high patients had a poorer prognosis with active surveillance compared to immune score low patients. However, despite this poorer prognosis, immune score high patients had improved 6- and 12-month progression free survival and 24-month overall survival with durvalumab maintenance therapy compared to the immune score high patients that received active surveillance. Analyses in the poster also compared the predictive potential of Xerna TME Panel classifications in esophagogastric adenocarcinoma to that of classifications based on PD-L1 combined positive score (CPS) status.

"Though specifically tailoring therapeutic regimens for individual patients can be an effective technique in the treatment of GI cancers, its application is limited by a lack of predictive biomarkers," said Professor Ian Chau, M.D., FRCP, co-author on the poster and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor at the Institute of Cancer Research, London & Surrey. "Data being presented at ESMO (Free ESMO Whitepaper) suggest the Xerna TME Panel can expand the applicability of personalized medicine in esophagogastric adenocarcinoma by predicting the patients who may benefit from anti-PD-1 maintenance therapy more accurately than PD-L1 CPS status. Moreover, classifications incorporating both PD-L1 CPS status and the Xerna TME Panel appear to further distinguish the subset of patients that will derive the most durable clinical benefit from checkpoint inhibitors. Taken together, these encouraging findings support the Xerna TME Panel’s potential as a diagnostic that can help us understand which patients are more likely to benefit from treatment and those that will not. This will hopefully lead to better treatment decisions and improved clinical outcomes for patients."

Key data featured in the ESMO (Free ESMO Whitepaper) poster are summarized in Tables 1A (patients randomized to active surveillance) and 1B (patients randomized to durvalumab maintenance therapy) below.

Table 1A: Survival function estimates for patients enrolled in the active surveillance arm according to Xerna TME Panel and PD-L1 CPS status. Data presented as: rate (97.5% confidence interval)

PFS: Progression-free survival; OS: Overall survival

Additionally, in PD-L1 CPS ≥5 patients who received durvalumab, 24-month OS rates were 38% and 0% in Xerna TME Panel immune score high (n=17) and low (n=9) subgroups, respectively. Twelve-month OS rates in the same subgroups were 44% and 33%, respectively.

Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics and co-author on the ESMO (Free ESMO Whitepaper) poster, commented, "These results add to an emerging dataset suggesting the Xerna TME Panel can improve the probability of success in clinical trials of not only our internally developed product candidates, navicixizumab and bavituximab, but in trials of a wide range of precision therapies. We are fortunate to be collaborating with leading experts from industry and academia on these efforts, including my co-authors from QIAGEN GmbH, Genialis, and The Royal Marsden. I look forward to continuing our work together as we strive to leverage the XERNA TME Panel to increase the number of cancer patients that can benefit from a precision medicine approach."

A copy of the ESMO (Free ESMO Whitepaper) poster, entitled: "Predicting benefit from maintenance durvalumab after first-line chemotherapy (1L CTx) in oesophagogastric adenocarcinoma (OGA) using a novel tumour microenvironment (TME) RNA assay," will be available on the OncXerna website following the conclusion of the ESMO (Free ESMO Whitepaper) Congress.

About PLATFORM
PLATFORM was a Phase 2, randomized, multicenter, adaptive study sponsored by The Royal Marsden NHS Foundation Trust that assessed various maintenance therapies in locally advanced or metastatic esophagogastric adenocarcinoma patients. Patients initially received standard chemotherapy according to local practice based upon their HER2 status. HER2-negative patients who completed at least six cycles of standard chemotherapy, achieved stable disease or better on the end-of-treatment CT scan, and met additional eligibility criteria were then randomized to receive active surveillance only or a selected maintenance therapy, one of which was durvalumab. Results showed durvalumab maintenance therapy did not prolong PFS or OS compared to active surveillance in HER2-negative patients unselected for PD-L1 status. For more information on the trial, see Clinicaltrials.gov Identifier: NCT02678182.

About the Xerna TME Panel
The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.