The ongoing phase III B-MIND study of tafasitamab (MOR208) has successfully passed the pre-planned, event-driven interim analysis for futility, according to MorphoSys, the agent’s developer.1
B-MIND is designed to compare the efficacy of the CD19 antibody, tafasitamab, plus bendamustine with rituximab (Rituxan) plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
The randomized, 2-arm, open-label study’s primary end point is progression-free survival. Secondary end points include objective response rate, duration of response, overall survival, disease control rate, and time to progression.
An independent data monitoring committee (IDMC) reviewed the data and recommended an increase in the number of patients from the current 330 to 450.
Following the current study protocol, enrollment will proceed according to the original inclusion and exclusion criteria to allow for ongoing comparison of the efficacy in the overall and biomarker positive patient population.
“DLBCL is a difficult to treat disease and has a high unmet medical need, so new treatment options are highly needed. Independent of B-MIND, we are on track to complete our BLA submission to the U.S. FDA for tafasitamab in combination with lenalidomide by the end of 2019 based on the previously reported encouraging results from the L-MIND and Re-MIND clinical studies,” Malte Peters, MD, Chief Development Officer of MorphoSys, said in a press release.
Previously, the FDA granted a breakthrough therapy designation for tafasitamab plus lenalidomide (Revlimid), as a potential treatment for patients with relapsed/refractory DLBCL.
“Independent of B-MIND, we are on track to complete our (biologics license application) submission to the US FDA for tafasitamab in combination with lenalidomide by the end of 2019 based on the previously reported encouraging results from the L-MIND and Re-MIND clinical studies,” Peters said in the release.
Morphosys announced that the top-line results of the phase I/II study will be made available in the first quarter of 2022.
1. MorphoSys’ tafasitamab B-MIND DLBCL study successfully passed futility analysis [news release]. Planegg/Munich, Germany. November 18, 2019. morphosys.com/media-investors/media-center/morphosys-tafasitamab-b-mind-dlbcl-study-successfully-passed-futility. Accessed November 19, 2019.