MorphoSys AG(FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today presented data from the primary analysis (cut-off date November 30, 2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND in an oral presentation at the 15thInternational Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
The L-MIND study enrolled patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The primary analysis data reported today included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update are based on response rates assessed by an independent review committee for all 80 patients. Patients enrolled had a median age of 72 years and had received a median of two prior treatment lines.
The primary endpoint, defined as best objective response rate (ORR) compared to published data on the respective monotherapies, has been met. The ORR was 60% (48 out of 80 patients), and the complete response (CR) rate was 43% (34 out of 80 patients). 82% of the CRs were PET (positron emission tomography)-confirmed. The median progression-free survival (mPFS) was 12.1 months with a median follow-up of 17.3 months. Responses were durable with a median duration of response (mDoR) of 21.7 months. Median overall survival (mOS) was not reached (NR) (95% CI 18.3 months – NR) with a median follow-up time of 19.6 months. The 12-month OS rate was 73.3%.
Efficacy parameters, such as response rates, showed comparable results in most patient subgroups of interest, including rituximab refractory versus non-refractory and primary refractory versus non-primary refractory, amongst others.
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