At the American Society of Hematology (ASH) Annual Meeting, held on 7-10 December, early results from the double-blind, randomised, placebo-controlled, Phase III inMIND clinical trial were presented. The trial evaluated the efficacy and safety of the combination of Incyte’s Monjuvi, Bristol Myers Squibb’s (BMS) Revlimid, and Biogen’s Rituxan in patients with difficult-to-treat relapsed or refractory (R/R) follicular lymphoma (FL) who received one or more prior lines of systemic therapy.

FL is the most common indolent form of B-cell non-Hodgkin’s lymphoma (NHL), accounting for approximately 20% of NHL cases. R/R FL has a progressively worsening prognosis with each subsequent relapse and lacks curative treatment options. According to leading data and analytics company GlobalData’s B-Cell Non-Hodgkin’s Lymphoma: Epidemiology Forecast to 2027 report, the number of diagnosed incident cases of FL in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) will grow to 28,561 cases by 2027. Monjuvi is an engineered anti-CD19 monoclonal antibody with a modified constant fragment (Fc) domain designed to enhance the binding of FcγRIIIa. It induces B-cell lysis through apoptosis and immune effector mechanisms.

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In the inMIND trial, a total of 548 patients with R/R FL (CD19+ and CD20+; grade 1-3A and approximately prior systemic therapy) were randomised 1:1 into experimental arm A (Monjuvi plus Rituxan plus Revlimid; n=273) and comparator arm B (placebo plus Rituxan plus Revlimid; n=275). The primary endpoint, median investigator-assessed progression-free survival (PFS), of Monjuvi plus Rituxan plus Revlimid was 22.4 months (hazard ratio [HR], 0.43; 95% confidence interval [CI]: 0.32, 0.58; P value <0.0001), compared to 13.9 months for placebo plus Rituxan plus Revlimid. A subgroup analysis also showed significantly improved PFS in arm A. At the primary analysis, the median follow-up was 15.3 months, and the secondary endpoint of overall survival did not reach maturity. Additionally, key secondary endpoints, including positron emission tomography complete response rate (49.4% for arm A versus 39.8% for arm B; P=0.0286) and overall response rate (83.5% for arm A versus 72.4% for arm B; P=0.0014), were higher while the duration of response (median 21.2 months for arm A versus median 13.6 months for arm B; HR, 0.47; 95% CI: 0.33, 0.68; P<0.0001) and time to next treatment (median not reached for arm A versus 28.8 months for arm B; HR 0.45; P<0.0001) were significantly better in arm A. Adverse events were comparable between the arms, and the study deaths (5.5% in arm A versus 8.5% in arm B) and disease progression (1.8% for arm A versus 6.3% for arm B) were slightly higher in arm B. This primary result suggests the use of Mojavi plus Rituxan plus Revlimid represents a potential new standard-of-care option for patients with FL whose disease has progressed after at least one prior therapy.

Monjuvi received its first accelerated US Food and Drug Administration (FDA) approval in 2020 for R/R diffuse large B-cell lymphoma (DLBCL) in combination with Revlimid. Building on the positive results from the inMIND trial, Incyte plans to file a supplementary Biologics License Application with the FDA by the end of 2024 for the treatment of patients with R/R FL who have failed prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. In February 2024, Incyte gained full rights to Monjuvi from its partner, MorphoSys, for $25m. The inMIND trial results have elevated expectations for Monjuvi’s commercial success. However, competition may arise from ADC Therapeutics’ Zynlonta, which is currently in a Phase II clinical trial for the same R/R FL indication. Additionally, Monjuvi would face competition from other therapies approved for R/R FL after two or more lines of systemic therapy, including Genmab’s Epkinly, Gilead and Kite Pharma’s Yescarta, Novartis’ Kymriah, Genentech’s Lunsumio, BeiGene’s Brukinsa, and BMS’ Breyanzi. According to GlobalData’s analyst consensus forecast, Monjuvi’s global sales are projected to reach $431m by 2030. Furthermore, Incyte is conducting a Phase III clinical trial (frontMIND) to evaluate Monjuvi as a first-line therapy for patients with R/R DLBCL. If Monjuvi gains approval for broader patient populations, it has the potential to secure a significant market share in the NHL space.

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