MorphoSys says tafasitamab B-MIND study successfully passed futility analysis
MorphoSys (MOR) announced that the ongoing tafasitamab phase 3 B-MIND study has successfully passed the pre-planned, event-driven interim analysis for futility.
An independent data monitoring committee reviewed the data and recommended to increase the number of patients from currently 330 to 450.
B-MIND compares the efficacy of the CD19 antibody tafasitamab plus bendamustine with rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma, or r/r DLBCL.
“Within the interim analysis for futility, data were assessed by the IDMC for the probability of a positive study at primary completion.
The IDMC assessed efficacy data in both the overall patient population as well as in the biomarker-positive subpopulation. The biomarker, described as patients with a low natural killer cell count at baseline, was implemented as a co-primary endpoint in an amendment of B-MIND in the first quarter 2019.
The recommendation to enroll more patients aims to increase statistical power of the study in the biomarker-described patient subpopulation as well as the overall patient population. Data of the analysis were not shared with MorphoSys.
As a continuation of the B-MIND 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.
Top line results are expected to be available in Q1 2022,” the company stated.
Piper Jaffray Comments
Piper Jaffray analyst Danielle Brill said news that MOR208 successfully passed the B-MIND trial futility analysis is “a positive clearing event for investors” that de-risks the stock, even though enrollment will be expanded from 300 to 450 patients and it is unclear how strong the efficacy signal was in the overall population.
She continues to expect FDA and EMA approval for MOR208 based on L-MIND data by mid-2020 and keeps an Overweight rating on MorphoSys shares.
MOR +$1.98 to $28.09.
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