Monjuvi scores a qualified indolent lymphoma success
Incyte’s plan to expand the anti-CD19 MAb Monjuvi beyond its approved diffuse large B-cell lymphoma indication could succeed – up to a point. The phase 3 Inmind study, in follicular as well as marginal zone lymphomas, has been toplined as positive for PFS, and Incyte says it now plans a US filing by the end of 2024; however, this will only be for follicular lymphoma. Inmind’s design was already skewed towards this indication: the primary endpoint was PFS specifically in follicular lymphoma, while PFS in the overall population, including marginal zone lymphoma, was relegated to a secondary. Yesterday Incyte said Monjuvi plus Rituxan and Revlimid hit both endpoints versus Rituxan and Revlimid alone, but said nothing specifically about marginal zone lymphoma. Incyte licensed Monjuvi from Morphosys, and gained full rights this year as a condition of that company’s takeover by Novartis. Expansion into follicular lymphoma could be important given that Monjuvi’s DLBCL nod is on an accelerated basis, and little has been said about the confirmatory B-Mind trial in that setting since a 2019 interim analysis recommended upsizing from 330 to 450 patients. According to the FDA Incyte has until the end of 2025 to deliver confirmatory DLBCL data.
Selected Monjuvi trials
| Study | Setting | Outcome |
|---|---|---|
| L-Mind | Ph2 Revlimid combo in r/r DLBCL | 55% ORR, backed 2020 accelerated approval for DLBCL |
| Inmind | Ph3 Rituxan + Revlimid combo in r/r FL & MZL | Toplined positive for PFS vs Rituxan + Revlimid in FL, and in overall population; FL filing planned by end 2024 |
| B-Mind | Ph3 confirmatory trial of bendamustine combo, vs Rituxan + bendamustine, in r/r DLBCL | Amended in 2019 to focus on biomarker (low baseline peripheral blood NK cell count); passed futility analysis with recommendation to expand enrolment from 330 to 450 patients; completed in Jun 2024, data expected by year-end 2024 |
Source: OncologyPipeline.
731
