Tafasitamab Plus Lenalidomide Added to NCCN Guidelines

The National Comprehensive Cancer Network (NCCN) has added tafasitamab to its clinical practice oncology guidelines for B-cell lymphomas.

The addition follows last month's FDA accelerated approval of tafasitamab (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), meeting the needs of patients who are not eligible for an autologous stem cell transplant.

The NCCN classified the treatment under its category 2A designation, which means that there is uniform consensus that the therapy is appropriate, based on lower-level evidence.

Tafasitamab is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies. As described in the journal Blood, the treatment uses Xencor’s proprietary Xmab technology, which deploys a different technique to boost affinity for the antigen and make various receptors especially capable of binding to it. In 2018, authors in Annals of Oncology described how this sets off particularly effective processes that target cancer cells and regulate cell death.

It is marketed by MorphoSys and Incyte.

“We are very gratified the NCCN acted quickly to include [tafasitamab-cxix] in combination with lenalidomide with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a treatment for patients with relapsed or refractory DLBCL who are not candidates for transplant. This targeted therapeutic option helps address an immediate medical need for patients who previously had limited treatment options,” Malte Peters, chief research and development officer at MorphoSys, said in a statement. “There is no other FDA-approved second line treatment for these patients with a 2A designation within the NCCN guidelines.”

Among non-Hodgkin lymphomas, DLBCL is the most common subtype, accounting for 22% of cases in the United States and 40% worldwide, with about 18,000 US cases per year. People are at higher risk if they have HIV, an autoimmune disease, or if they have had an organ transplant. More common in older people, DLBCL can be very aggressive. Although well-known treatments have been developed, there are gaps—and a notable one is when DLBCL cannot be kept in remission after chemotherapy but the patient is not eligible for an autologous stem cell transplant. Some of these patients have had chimeric antigen receptor (CAR) T-cell therapy, but this process is costly with significant side effects.