Allarity Says Initial Data Show Improved Clinical Benefit In Breast Cancer Patients Selected Via Companion Diagnostic

Allarity Therapeutics Inc ALLR announced initial results from its European Phase 2 clinical trial evaluating the efficacy of Ixempra in metastatic breast cancer (mBC) patients selected with the DRP-Ixempra companion diagnostic (CDx) candidate. 

Of the 36 patients screened with the DRP-Ixempra CDx, investigators identified five DRP-positive patients. 

Among the evaluable patients assessed up to the data evaluation cut-off, there were promising signs of clinical benefit in four out of four evaluable cases:

One partial responder (PR) (tumor shrinkage of 66%).

One partial responder (PR) (tumor shrinkage of 59%).

One patient experienced 24 weeks of stable disease.

One patient experienced 19 weeks of stable disease.

The study is in a very early stage of an ongoing open-label, single-arm trial at multiple sites in Europe, evaluating the anti-tumor effect of Ixempra in patients with locally recurrent or metastatic breast cancer after previous chemotherapies.

The company anticipates an additional interim data readout before the end of this year.

Also Read: Allarity Outlines Steps To Accelerate Delayed Recruitment In Ixempra, Stenoparib Cancer Trials.

Ixempra was initially developed by Bristol Myers Squibb & Co BMY and is approved for metastatic breast cancer patients in the U.S., where R-PHARM U.S., LLC markets it. 

Allarity has the exclusive option rights for developing and commercializing Ixempra in Europe.

The FDA-approved Ixempra label 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-guided Phase 2 study of Ixempra suggest that the DRP-Ixempra CDx may identify a subset of patients who potentially have an improved ORR and CBR compared to monotherapy efficacy.

Price Action: ALLR shares are up 61.61% at $10.18 on the last check Wednesday.