Morphosys/Incyte’s Monjuvi becomes first approved therapy for relapsed and refractory DLBCL in second-line treatment setting

GlobalData Healthcare 7 August 2020 (Last Updated August 7th, 2020 13:40)

Morphosys/Incyte’s Monjuvi becomes first approved therapy for relapsed and refractory DLBCL in second-line treatment setting

Treatment of diffuse large B-cell lymphoma (DLBCL), the most common type of B-cell non-Hodgkin’s lymphoma, had seen a major transformation with the incorporation of Roche’s CD20 targeting antibody Rituxan (rituximab) as the backbone of combination therapies in all treatment settings.

Morphosys and Incyte’s CD19-targeting antibody Monjuvi (tafasitamab), in combination with Celgene’s Revlimid (lenalidomide), became the first agent to be approved for the second-line treatment of relapsed and refractory DLBCL, based on the results from the Phase II L-MIND study. In light of this approval, Monjuvi + Revlimid will be directly competing against Roche’s antibody drug conjugate Polivy, in combination with Rituxan and Treanda (bendamustine), in the relapsed/refractory treatment setting. Morphosys and Incyte collaboratively ran a comparative study for Monjuvi + Treanda against Rituxan + Treanda in the same treatment setting, and the companies also plan to initiate a Phase III study in the first-line treatment setting in 2021, which will ultimately threaten Roche’s well-established DLBCL franchise.

At the European Hematology Association’s virtual conference, Morphosys reported results from the L-MIND study. In the overall patient cohort, Monjuvi established a 59% objective response rate (ORR) and a 41% disease clearance rate, with a median duration of response (DOR) of 34.6 months. Based on these results, a high market uptake is anticipated for Monjuvi in the second-line treatment setting. The combination of Polivy + Rituxan and Treanda was approved in the third-line and beyond treatment setting, and according to the registrational Phase I/II study GO29365, in relapsed/refractory DLBCL patients who had received at least two previous lines of therapy this regimen achieved a 45% ORR and a median DOR of 6–12 months. Since head-to-head comparison could be misleading due to differences in trial design and recruited patient groups, a high level of competition is expected between these two combination regimens in the third-line and beyond treatment setting.

The ongoing Phase II/III B-MIND study compares Monjuvi + Treanda to Rituxan + Treanda in patients with relapsed and refractory DLBCL. The results from this trial could establish Monjuvi as a preferred combination partner over Rituxan in the relapsed and refractory disease setting. However, Rituxan has lost its market exclusivity in all major markets, therefore, rituximab biosimilars could hinder Monjuvi’s uptake in the later lines of therapy.

Lastly, Morphosys disclosed plans for initiating a Phase III trial for Monjuvi in the first-line treatment setting in 2021. Although the details of the clinical trials design have not fully emerged, a potential expansion for Monjuvi into the first-line treatment setting would ultimately have a greater impact on Roche’s sales shares in the DLBCL market.