07 Aug 2020
Posted in Pharma
Monjuvi approval in relapsed/refractory DLBCL could lead home run for Morphosys/Incyte against big players, says GlobalData
Following the FDA’s recently granted accelerated approval for Morphosys and Incyte’s CD19 targeting antibody Monjuvi (tafasitamab), Morphosys and Incyte partnership now pushes forward to compete with Roche’s well-established diffuse large B-cell lymphoma (DLBCL) franchise as the go-to option in the second line and beyond treatment setting. Monjuvi could represent a safer, more effective, and affordable option to CD19 targeting, with potential use across different treatment settings, as well as offer an alternative to Rituxan-based combination therapies
Ufuk Ezer, Oncology and Hematology Analyst at GlobalData, commented: “The objective response (OR) and the duration of response (DOR) in the recent L-MIND study appear to be significantly better than what was reported for Polivy + Treanda (bendamustine) and Rituxan (rituximab) in the Phase I/II GO29365 study conducted in relapsed/refractory patients who were treated with at least two previous lines of therapy. While a head-to-head comparison could be misleading, the ongoing Phase II/III B-MIND study, comparing Monjuvi + Treanda against Rituxan + Treanda in the same treatment setting, could ultimately establish Monjuvi as an ideal combinatorial agent for the treatment of relapsed and refractory DLBCL.”
In 2019, Rituxan was estimated to have generated over $1.2bn sales from DLBCL across all lines of therapy, where the bulk of the sales could be attributed to its use in the first line setting.
Ezer continues: “Although, Rituxan forms the backbone of combination therapies in the first line setting, most of the DLBCL patients either relapse on Rituxan-based therapies or are refractory to Rituxan. Finding alternatives to Rituxan based combination therapies, particularly in the relapsed/refractory setting but also in the first line setting, is one of the factors driving the innovation in the DLBCL pipeline.”
Morphosys also disclosed plans to initiate a Phase III trial for Monjuvi in the first line setting in 2021, which draws the drug’s peak sales projections toward $1bn.
Ezer concludes, “In the third line and beyond treatment setting, Yescarta and Kymriah are effective treatment options, both targeting B cells expressing CD19. However, there are certain challenges with CAR-T’s that make them less accessible treatment options. Yescarta and Kymriah are expensive therapies and associated with various safety concerns. In addition, there are other manufacturing and administration-related limitations that are common to CAR-Ts. This could give Monjuvi an advantage as it provides a safer, more effective, and affordable option.”
To find out more, send your questions to Rebecca Panks, PR Executive at GlobalData (email@example.com)