On December 30, 2019 MorphoSys (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it has filed a biologics license application (BLA) for tafasitamab with the United States Food and Drug Administration (FDA) , Tafasitamab is MorphoSys anti-CD19 antibody, which is currently in clinical development for the treatment of therapy-resistant or recurrent diffuse large B-cell lymphoma (R / R DLBCL) (Press release, MorphoSys, DEC 30, 2019, View Source [SID1234552626]). The application for approval is based on the data from the primary analysis of the L-MIND study with tafasitamab in combination with lenalidomide in patients with R / R DLBCL as well as the data from the primary analysis of the retrospectively considered suitable control group (Re-MIND), which showed the effectiveness of a lenalidomide -Monotherapy in R / R DLBCL patients examined.
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"The submission of the BLA marks an important milestone in the history of MorphoSys and shows our commitment to address the high medical need for therapy-resistant or recurrent DLBCL," said Dr. Malte Peters, Chief Development Officer at MorphoSys. "If approved, tafasitamab and lenalidomide could be an alternative treatment for these critically ill patients."
The FDA has a 60-day period to review the application for completeness and as sufficient for an application for approval. MorphoSys will communicate the authority’s decision.
About L-MIND
L-MIND is a one-arm, open-label phase 2 study that examines the combination of tafasitamab and lenalidomide in patients with relapsed or refractory large cell B-cell lymphoma (R / R DLBCL) using up to two previous therapy lines, at least one have received anti-CD20-directed therapy (e.g. with rituximab) and are not suitable for high-dose chemotherapy and subsequent autologous stem cell transplantation. The primary endpoint of the study is the overall response rate (ORR). Secondary endpoints include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019. The primary analysis data (as of November 30, 2018) was based on 80 patients enrolled in the study, who had received tafasitamab and lenalidomide and had been observed for at least one year according to the study protocol. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019.
About Re-MIND
Re-MIND, a retrospective observational study, was designed to isolate the contribution of tafasitamab to the combination with lenalidomide and to demonstrate the combinatorial effect. The study compared the real response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy to the efficacy results of the tafasitamab-lenalidomide combination as examined in MorphoSys’s L-MIND study. Re-MIND collected efficacy data from 490 r / r DLBCL patients in the United States and the EU. Eligible patients were assigned 1: 1 to the L-MIND study population, based on important basic characteristics such as relevant prognostic factors, laboratory values and patient demography.
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 to be a critical component for B cell receptor (BCR) signaling.
MorphoSys untersucht Tafasitamab als therapeutische Option bei B-Zell-Malignomen in einer Reihe von laufenden Kombinationsstudien. Die offene Phase-2-Kombinationsstudie (L-MIND-Studie) untersucht die Sicherheit und Wirksamkeit von Tafasitamab in Kombination mit Lenalidomid bei Patienten mit rezidivierender/refraktärer DLBCL, die nicht für eine Hochdosis-Chemotherapie (HDC) und autologe Stammzelltransplantation (ASCT) in Frage kommen. Basierend auf vorläufigen Daten von L-MIND hat die FDA im Oktober 2017 den Status Therapiedurchbruch für Tafasitamab plus Lenalidomid in dieser Patientenpopulation erteilt.
Re-MIND, the real world data study in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated the clinical superiority of the tafasitamab / lenalidomide combination over lenalidomide alone. B-MIND is an ongoing phase 3 study that investigates the combination of tafasitamab and bendamustine in comparison with rituximab and bendamustine in r / r DLBCL. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL after discontinuation of previous Bruton tyrosine kinase inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or Venetoclax.