CASI Pharmaceuticals, Inc. has reported that a decision has been reached to stop further patient enrollment in its Phase 2, open-label study of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer (TNBC) conducted at the University of Colorado, Denver and the Indiana University Melvin and Bren Simon Cancer Center.

The study was a two-stage design which targeted an accrual of 35 patients. The patient number was expanded to take into consideration those patients which may not be evaluable for efficacy analysis as per the protocol.

A total of 41 patients have been enrolled which has been determined to be sufficient to assess the potential efficacy of ENMD-2076 in this patient population and for ongoing biomarker analysis. CASI continues to collect and evaluate data in those patients enrolled in the study and the biomarker program which evaluates potential markers that could be predictive of a response to ENMD-2076 is ongoing.

"We continue to evaluate the maturing data including the biomarker analysis to determine the potential future development path in patients with TNBC," said Dr. Alex Zukiwski, CASI's Chief Medical Officer. "Identifying markers predictive of response to ENMD-2076 in patients with TNBC would be helpful to future development as a single agent, as well as consideration of any additional trials where ENMD-2076 could be combined with approved agents to increase clinical benefit."