On December 27, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that the first patient in a clinical phase 1b study in newly diagnosed diffuse large B-cell lymphoma (DLBCL) with the MorphoSys’s own human anti-CD19 antibody tafasitamab was dosed (Press release, MorphoSys, DEC 27, 2019, View Source [SID1234552617]). The Phase 1b study is an open, randomized, multicenter study to evaluate the safety and preliminary efficacy of tafasitamab in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) compared to tafasitamab and lenalidomide as well as R-CHOP adult patients with newly diagnosed, previously untreated DLBCL. The patients in each study arm receive six treatment cycles with a follow-up period of up to 24 months.
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"We are very excited to expand the clinical development of tafasitamab to include first-line DLBCL," said Dr. Malte Peters, MorphoSys’s Chief Development Officer. we are now excited to investigate the potential of our most important program in combination with R-CHOP or lenalidomide and R-CHOP in newly diagnosed DLBCL. This phase 1b study is the basis of a subsequent phase 3 approval study in first-line DLBCL. DLBCL is an aggressive and difficult to treat disease and we hope to improve the current standard R-CHOP therapy by adding tafasitamab and lenalidomide,
About Tafasitamab (MOR208)
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody to CD19. The Fc modification of tafasitamab is said to lead to a significant increase in the antibody-dependent cell-mediated cytotoxicity (ADCC) and the antibody-dependent cellular phagocytosis (ADCP) and thus improve a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered a critical component for B cell receptor (BCR) signaling.
MorphoSys is investigating tafasitamab as a therapeutic option for B cell malignancies in a number of ongoing combination studies. The phase 2 combination study (L-MIND study) examined the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who were not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) come. Based on preliminary data from L-MIND, the FDA granted therapeutic breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. B-MIND is a phase 3 study that investigates the combination of tafasitamab and bendamustine compared to rituximab and bendamustine in r / r DLBCL.