!--webeditor: "page title"--// Morpho Sys and Incyte recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi (tafasitamab-cxix, MOR 208), the combination of lenalidomide, for the treatment of recurrent or refractable diffuse large B-cell lymphoma (r/r DLBCL) patients who are not suitable for an autonomous stem cell transplant (ASCT), including DLBCL derived from low-level lymphoma.
based on Total Remission Rate (ORR) data, Monjuvi has received FDA accelerated approval, and continued approval for the indication may depend on the validation and description of the clinical benefits in validation trials.
note, Monjuvi is the first FDA-approved second-line therapy for r/r DLBCL adult patients whose condition progresses during or after first-line treatment.
previously, the FDA has granted Monjuvi fast-track, breakthrough drug, and priority review.
Monjuvi is also under review by the European Medicines Agency (EMA).
Monjuvi's active pharmaceutical ingredient is tafasitamab, a new type of human-derived Fc domain optimized solute cell-based CD19 targeted immuno-enhanced monoclonal antibody, CD19 is a clear biomarker of a variety of B-cell malignancies.
currently, tafasitamab is currently in clinical development for the treatment of a variety of B-cell malignancies.
this approval is based on data from the L-MIND study.
this is an open-label, multi-center, one-arm phase II study that evaluated patients with Monjuvi combined with nadoamine treatment who have previously received at least one but no more than three treatments (including one anti-CD20 targeted therapy, such as r/r DLBL), ineligible for high dosechemotherapy (HDC) and subsequently self-contained stem cell transplants (ASCT).
results showed that the total remission rate (ORR) of Monjuvi-renadoamine combination therapy was 55% (primary endpoint), the total remission rate (CR) was 37% and the partial remission rate (PR) was 18%.
mitigation is persistent, with a median mitigation duration (mDOR) of 21.7 months (critical secondary endpoint).
Monjuvi's warnings and precautions include infusion-related reactions (6%), severe or severe bone marrow inhibition (including neutrophil reduction (50%), platelet reduction (18%) and anemia (7%), infection (73%) and embryo-fetal toxicity.
neutrophil reduction caused 3.7% of patients to stop treatment. The most common adverse reactions
were neutrophil reduction, fatigue, anemia, diarrhea, platelet reduction, cough, fever, peripheral edema, respiratory infections and decreased appetite.
B cell CD19 expression and tafasitamab mechanism of action is a new type of humanized Fc enhanced monoclonal antibody targeting CD19, and its Fc domain has been modified (including 2 amino acids to replace S239D and I332E), improving the key mechanisms of tumor cell killing by significantly enhancing the affinity of the active Fc-RiIia on the effect cells, significantly enhancing the cytotoxicity (ADCC) of antibody-dependent cells and antibody-dependent cell phagocytosis (ADCP).
preclinical model study, tafasitamab has been shown to induce direct apoptosis of cancer cells by binding to CD19.
currently, tafasitamab is being developed for two types of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and DLBCL.
globally, CLL is the most common type of leukemia in adults, and DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) in adults, accounting for 40% of all NHL cases.
DLBCL is an invasive disease that affects the immune system B cells and is characterized by the rapid growth of malignant B cells in the lymph nodes, spleen, liver, bone marrow, or other organs.
30%-40% of patients have no response to initial treatment or relapse after the initial treatment, and there are significantly unmet medical needs for effective treatment.
in the United States, about 10,000 patients are diagnosed each year with r/r DLBCL that does not qualify for ASCT.
2010, MorphoSys obtained exclusive development and commercialization rights to tafasitamab worldwide from Xencor.
in January, MorphoSys signed a $2 billion global partnership and licensing agreement with Incyte to jointly develop and commercialize tafasitamab.
agreement, MorphoSys and Incyte will co-commercialize Monjuvi (tafasitamab) in the United States, with Incyte having exclusive commercial rights outside the United States, including Europe.
"CAR-T Killer": Tafasitamab will challenge the two CD19 CAR-T therapies that are listed, analysts point out that tafasitamab will directly challenge the two anti-CD19 CAR-T therapies that are on the market for R/R DLBCL- Novartis Kymriah and Gilead Yescarta.
CAR-T therapy is different from conventional small molecule or biological therapy, which is a living T-cell therapy product.
The Kymriah and Yescarta treatment processes are required to isolate the patient's T cells and genetically modify them in vitro to enable T cells to express a chimeric antigen receptor (CAR) designed to target CD19, after which the modified T cells are returned to the patient to find cancer cells that express CD19 and play a therapeutic role.
efficacy, tafasitamab is comparable to Kymriah and Yescarta.
medication, Both Kymriah and Yescarta are prepared separately for each patient and take a certain amount of time, while tafasitamab is an industrialproduction of ready-to-use monotoms, ready-to-use.
treatment costs, Kymriah and Yescarta both cost hundreds of thousands of dollars, while tafasitamab can control very little.
analysts likened tafasitamab to "CAR-T cell therapy killers", a drug that, if successfully launched, would have a huge impact on Kymriah and Yescarta.
(!--/ewebeditor:page-!---ewebeditor:""-sic: FDA Approves Monjuvi (R) (tafasitamab-cxix) Combination in with Lenalidomide for the Treatment of Adult Patients with laps Reed !-- or