Allarity Therapeutics, Inc. announced initial results from its European Phase 2 clinical trial evaluating the efficacy of IXEMPRA(R) in metastatic breast cancer (mBC) patients selected with the DRP(R) -IXEMPRA(R) companion diagnostic (CDx) candidate. Researchers prescreened mBC patients using Allarity's DRP(R)-IXEMPRA(R) CDx, a complex transcriptomic signature comprising multiple mRNA biomarkers of drug response/resistance. The included patients received a maximum of three prior lines of chemotherapies in the metastatic setting.

Allarity recently amended the clinical trial protocol, lowering the DRP(R) cut-off score in order to include more likely responder patients while still excluding those unlikely to respond to the drug. The ultimate objective is to further refine the DRP(R)-ixEMPRA(R) CD x criteria and broaden the enrollment of mBC patients who may substantially benefit from this treatment. Using the DRP(R) CDx to select likely responder patients while excluding likely resistant ones, Allarity aims to improve the benefit-risk ratio of IXEMPRA(R") in metastatic or locally advanced breast cancer.

The U.S. FDA-approved IXEMPRA(R) label currently indicates a monotherapy efficacy with an objective response rate (ORR) of 12.4% and a clinical benefit rate (CBR) of 24.8% in metastatic or locally advanced Breast cancer. However, the initial data from the ongoing DRP(R) -guided Phase 2 study of IXEMPRA(R). IXEMPRA(R) suggest that the DRP(R) --IXEMPRA(R) -IXEMPra(R) CDx may identify a subset of patients who potentially have an improved ORR and CBR as compared to monotherapy efficacy indicated by the U.S. FDA- approved label for the drug.

The DRP(R) -ixEMPRA(R)CDx is a clinical stage companion diagnostic candidate and has not yet been approved by the U.S.F. FDA or the EMEA. Early trial results are insufficient to show statistical significance and may not be a reliable indicator of subsequent trial results based on a larger patient population.