Incyte’s Monjuvi is approved by the US FDA as a second-line treatment of relapsed and refractory diffuse large B cell lymphoma (DLBCL) in combination with lenalidomide. Image Credit: Bo Shen / Shutterstock.

Incyte has announced positive topline data from the Phase III inMIND trial evaluating its CD19-targeting monoclonal antibody Monjuvi (tafasitamab) in patients with relapsed or refractory (r/r) follicular lymphoma.

The company plans to seek label expansion for Monjuvi as a second-line treatment for follicular lymphoma, with a supplemental biologics licence application submission expected by the end of the year. The Phase III trial evaluated the triple therapy of Monjuvi, lenalidomide, and Roche’s Rituxan (rituximab) versus the double treatment of lenalidomide and Rituxan.

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Monjuvi was developed in collaboration with MorphoSys, with Incyte purchasing it outright in February for $25m. It is approved by the US Food and Drug Administration (FDA) as a second-line treatment of r/r diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide.

According to MorphoSys financials, Monjuvi pulled in $92m in US sales last year. It is marketed as Minjuvi in Europe and Canada. GlobalData expects the therapy sales to increase to over $400m by 2030. 

GlobalData is the parent company of Clinical Trials Arena.

The placebo-controlled Phase III inMIND trial (NCT04680052) enrolled 654 participants. Incyte was light on details, but stated that the study met its primary endpoint of progression-free survival (PFS) by investigator assessment. The trial also met its secondary endpoint of investigator-assessed PFS in the overall participant group.

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Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic system, which is characterised by the abnormal growth of B cells in the lymph nodes.

There is stiff competition in r/r follicular lymphoma treatment market, with multiple approved treatment options. In March, BeiGene’ BTK inhibitor Brukinsa (zanubrutinib) secured an accelerated approval in combination with Roche’s Gazyva (obinutuzumab) from the US FDA as a third-line therapy in the indication. Chimeric antigen receptor (CAR)-T cell therapies, such as Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences Yescarta (axicabtagene ciloleucel), have also received accelerated approval as a third-line treatment for follicular lymphoma.