CASI Pharmaceuticals, a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported that, along with the investigators, a decision has been reached to stop further patient enrollment in its phase II, 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 that 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. In this uncommon tumor type and challenging setting to recruit, 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 our ongoing biomarker analysis. The company 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. In addition, the ongoing phase IIa study in China in patients with TNBC continues to accrue patients in the dose escalation phase, the primary objective of which is to determine the recommended phase II dose in Chinese study subjects. This dose escalation phase is expected to reach the full accrual target in Q3 2017.
Dr. Alex Zukiwski, CASI's chief medical officer, commented, "We continue to evaluate the maturing data including the biomarker analysis to determine the potential future development path in patients with TNBC. 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."
Along with the investigators, the company plans to present the study results at the next available opportunity.