Xencor, MorphoSys AG and Incyte announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys’ in-licensing of tafasitamab in 2010.”

‟Tafasitamab in combination with lenalidomide is an important new relapsed/refractory DLBCL treatment option for appropriate patients in the United States today, and its mechanism of action, efficacy and safety profile make it an attractive combination partner,” said Jean-Paul Kress, M.D., chief executive officer of MorphoSys. “We believe that tafasitamab as a backbone can add value to new combinations such as with CD20 x CD3 bispecific, and we are excited about this collaboration with Xencor and Incyte aiming to help more patients in areas of unmet need.”

‟This collaboration has the potential to advance patient care and Incyte is proud to join Xencor and MorphoSys in evaluating this new combination approach for these serious cancers,” said Hervé Hoppenot, chief executive officer of Incyte.

Xencor’s plamotamab is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Tafasitamab is MorphoSys' CD19-directed antibody which was recently approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab, and lenalidomide in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combination in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies. MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and are planned to be conducted in North America, Europe, and Asia-Pacific.

The collaboration is effective immediately upon the execution of the agreement.