On May 31, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published online in The Lancet Oncology suggest that the company’s Immunoscore Immune Checkpoint (IC) assay may identify patients with metastatic colorectal cancer (mCRC) who are likely to benefit from the addition of immune checkpoint inhibitor (ICI) therapy to standard first-line treatment (Press release, Veracyte, MAY 31, 2022, View Source [SID1234615272]). The findings are from the randomized, controlled, phase II AtezoTRIBE trial, a multicenter Italian clinical study, sponsored by GONO Foundation.
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The vast majority of mCRC tumors (approximately 95 percent) have a proficient DNA mismatch repair (pMMR) system and are microsatellite stable. These tumors have low immunogenicity and do not derive benefit from immune checkpoint inhibitors. Previous research suggests that the FOLFOXIRI and bevacizumab combination enhances immunogenicity in pMMR mCRC. In the current study, researchers found a modest benefit of the experimental treatment regimen in this subgroup.
"AtezoTRIBE is the first to show that the addition of the PD-L1 inhibitor atezolizumab to standard first-line treatment (FOLFOXIRI plus bevacizumab) improved progression-free survival in patients with previously untreated mCRC," said Chiara Cremolini, M.D., Ph.D., principal investigator of the trial and oncologist at the Pisa University Hospital in Italy.
Additionally, post-hoc statistical analyses designed to evaluate the association of immune-related biomarkers with treatment outcomes found a meaningful correlation between a "high" Immunoscore IC result and response to the experimental treatment regimen (p=0·003).
"To our knowledge, Immunoscore IC is the first biomarker with potential predictive value in selecting patients with pMMR metastatic colorectal cancer who are likely to benefit from the use of immune checkpoint inhibitors," said Carlotta Antoniotti, M.D., oncologist at the Pisa University Hospital and lead author of the new paper. "These findings must be confirmed in further prospective studies, but are encouraging as a means of addressing a significant unmet need."
"These findings are exciting, as they suggest new potential avenues for the use of the Immunoscore IC assay in identifying patients with metastatic colorectal cancer who may benefit from ICIs," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "We believe the assay could help companies developing ICIs by enabling them to better identify appropriate patients for clinical trials."
About Immunoscore IC
Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells, on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a clinical research service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.