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NCI-MATCH Umbrella Trial Adds Arm for LAG-3 Expressing, Mismatch Repair Deficient Cancers

NEW YORK – The ECOG-ACRIN Cancer Research Group and National Cancer Institute on Wednesday said that they have opened a new treatment arm of the ongoing NCI-MATCH trial, which will enroll patients whose cancers harbor DNA mismatch repair deficiencies (dMMR) and express LAG-3.

The new arm of NCI-MATCH — a sweeping precision oncology umbrella trial comprising over three dozen cohorts of patients matched to treatment based on the molecular characteristics of their cancers — will evaluate whether patients with dMMR and LAG-3 expression can benefit from combination treatment with Bristol Myers Squibb's Opdivo (nivolumab) and investigational LAG-3 blocking antibody relatlimab.

To enroll in the new NCI-MATCH treatment arm, dubbed Z1M, patients must have progressed after prior treatment with anti-PD-1/PD-L1 checkpoint inhibitors. Importantly, patients with melanoma are not eligible to enroll in arm Z1M because the Phase III RELATIVITY-047 trial has already demonstrated the treatment combination's benefit in this patient population. The US Food and Drug Administration is currently in the process of reviewing BMS' application to bring the relatlimab-Opdivo combination to market for advanced melanoma patients.

ECOG-ACRIN and the NCI also announced Wednesday that the trial will continue enrolling patients whose cancers harbor BRAF mutations to Arm H, which is evaluating treatment with Novartis' Tafinlar and Mekinist (dabrafenib and trametinib). Results from this arm previously showed that the targeted therapy combination led to responses across multiple BRAF-mutated cancer types. Now, the researchers aim to confirm their findings by enrolling additional patients.

Together, the new arm and the expanded Arm H will add an estimated 85 patients to the trial, which has already treated nearly 1,200 patients across 40 unique molecular target-treatment matches. Most existing NCI-MATCH treatment arms are no longer enrolling patients, and researchers are in the process of following treated patients and publishing results — including outcomes, genomic analyses, and conclusions — from the different arms.

"The emergence of these two combination arms to represent the culmination of research in NCI-MATCH is no accident and has arisen organically from the aggregated results of the trial to date," ECOG-ACRIN co-Chair Peter O'Dwyer said in a statement.