First Patient Dosed in Trial Evaluating Tafasitamib, Lenalidomide, R-CHOP for DLBCL

For many patients with diffuse large B-cell lymphoma (DLBCL), one first-line treatment is rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, even aggressive chemotherapy is not always enough for patients with high-risk DLBCL. Unfortunately, in high-risk cases, outcomes are relatively poor. Thus, there is a need to discover new therapies to help improve patient outcomes. According to Pipeline Review, a Phase 3 clinical trial is currently attempting to achieve this goal.

Within the Phase 3 frontMIND clinical trial, researchers are exploring tafasitamab and lenalidomide in conjunction with R-CHOP. During the trial, researchers will evaluate whether this is ultimately more effective for previously untreated patients. As of May 12, 2021, biopharmaceutical companies Incyte and MorphoSys AG (“MorphoSys”) shared that the first patient was dosed within the study.

Tafasitamab

So why is there a need for new DLBCL treatments? According to data, an estimated 40% of patients with treatment-naive DLBCL either relapse on R-CHOP – or fail to respond to treatment at all. Prior studies from 2020 highlighted how adding tafasitamab alone, or in conjunction with lenalidomide, to treatment was relatively safe, effective, and well-tolerated. In fact, over 90% of patients in the Phase 1b firstMIND clinical trial responded to this treatment. In 2020, Monjuvi (tafasitamab-cxix) was also approved, in conjunction with lenalidomide, for adult patients with DLBCL.

Now, frontMIND will continue to explore tafasitamab and lenalidomide for patients with DLBCL. According to MorphoSys, tafasitamab is:

an investigational monoclonal antibody directed against the antigen CD19 which is broadly expressed on the surface of B cells. It is therefore considered as a potential target for the treatment of B cell malignancies, such as non-Hodgkin’s lymphoma (NHL), including diffuse large B cell lymphoma (DLBCL), as well as chronic lymphocytic leukemia (CLL).

A monoclonal antibody is considered a lab-developed antibody or protein that mimics immune response. In this case, tafasitamab helps the body to target – and attack – CD19.

Altogether, 880 patients with DLBCL will enroll in frontMINDIn addition to garnering data on safety, efficacy, and tolerability, the trial will also explore progression-free survival (PFS) and overall survival (OS) rates, among others.

MONJUVI for DLBCL

Currently, MONJUVI (tafasitamab-cxix) is approved for use in adult patients with DLBCL. You should not use MONJUVI if you are pregnant, might become pregnant, or breastfeeding. While MONJUVI is relatively safe and well-tolerated, some adverse reactions may occur. These include:

  • General malaise
  • Cough
  • Fever
    • Note: If experiencing a fever over 100.4 degrees while on MONJUVI, please talk to your doctor immediately.
  • Anemia (low red blood cell count)
  • Neutropenia (low white blood cell count)
  • Thrombocytopenia (low platelet count)
  • Diarrhea
  • Swelling of the hands or lower legs
  • Respiratory tract infections
  • Appetite loss
  • Shortness of breath/difficulty breathing

Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL). This extremely aggressive cancer forms in lymphocytes, a type of white blood cell. While doctors do not know the exact cause of DLBCL, risk factors include being immunocompromised or having a weakened immune system, a family history of DLBCL, or having an autoimmune disorder. Although DLBCL can occur at any age, it typically impacts older individuals (60+). Although DLBCL can occur throughout the body, it is most commonly found in the lymph nodes, particularly near the groin, neck, or armpits.

Symptoms include:

  • Unintended weight loss
  • Pruritus (intense itching)
  • Painless lymph node inflammation
  • Fever
  • Night sweats
  • Abdominal or chest pain or pressure
  • Shortness of breath
  • Diarrhea or gastrointestinal bleeding
    • Note: While not common symptoms, abdominal or gastrointestinal symptoms may appear if the cancer has metastasized throughout the body.
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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