At the American Society of Hematology (ASH) Annual Meeting, held on 6-9 December, results from the global, multicentre, open-label, randomised, Phase III EPCORE FL-1 clinical trial were presented. This trial evaluated the safety and efficacy of the combination of AbbVie and Genmab’s Epkinly (epcoritamab), a CD3xCD20 bispecific T-cell engager antibody, in combination with Bristol Myers Squibb’s Revlimid and Biogen’s Rituxan as a second-line treatment for patients with relapsed/refractory (R/R) follicular lymphoma (FL).
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 2033 report, the number of diagnosed incident cases of FL in the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan) will grow from 31,049 cases in 2025 to 32,741 cases by 2033.
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In the EPCORE FL-1 clinical trial, a total of 488 patients with FL who received at least one prior systemic regimen that contained an anti-cluster of differentiation (CD20) monoclonal antibody in combination with chemotherapy were randomised 1:1 to experimental arm A (Epkinly plus Revlimid plus Rituxan; n=243) and comparator standard-of-care (SOC) arm B (Revlimid plus Rituxan; n=245). In the second planned interim analysis, the primary endpoint of overall response rate was 95% in the Epkinly arm (95% confidence interval [CI]: 91.5, 97.4) compared to 79% in the SOC arm B (95% CI: 73.6, 84.1; P<.0001). The risk of disease progression or death was reduced by 79% in the Epkinly arm compared to SOC (hazard ratio 0.21, 95% CI: 0.14-0.31, p<0.0001). In addition, at a median follow-up of 14.8 months, the complete response rate reached 83% in the Epkinly arm (201 of 243; 95% CI: 77.4-87.3), compared with 50% in the SOC arm (122 of 245; 95% CI: 43.4-56.2). The 12-month duration of response was also markedly higher with the triplet at 89% (95% CI: 83.6-93.0) versus 49% (95% CI: 38.8-57.5) for the SOC arm. The experimental arm showed a manageable safety profile. Grade 3 or 4 treatment-emergent adverse events occurred more often in the Epkinly arm (90.1% versus 67.6% in the SOC arm), mainly due to higher rates of severe neutropenia (68.7% versus 42.0%, respectively) and infections (33.3% versus 15.1%, respectively). Fatal events were infrequent in both arms (1.6% versus 3.8%, respectively), and discontinuations occurred in 18.9% versus 12.2% of patients, respectively.
Based on these results, the Food and Drug Administration approved Epkinly plus Revlimid plus Rituxan for adults with R/R FL as second or later systemic therapy in November 2025. This regimen previously received a breakthrough therapy designation in the same setting. Epkinly monotherapy was also granted accelerated approval for R/R FL prior to this combination approval, following its earlier approval in 2023 for diffuse large B-cell lymphoma after two or more prior lines of therapy.
Epkinly now enters a competitive R/R FL landscape that includes other CD20×CD3 bispecifics such as Roche’s Lunsumio, which is being evaluated in the Phase III CELESTIMO trial; antibody-based triplets such as Incyte’s Monjuvi, in the Phase III InMIND trial; and Regeneron’s Ordspono, in the Phase III OLYMPIA-5 trial. Roche is taking a different approach from AbbVie and Genmab, evaluating Lunsumio plus Revlimid against the SOC regimen while Regeneron is pursuing a similar strategy with Ordspono. According to GlobalData’s analyst consensus forecast, global sales of Epkinly are projected to reach $2.6bn by 2031, and this new second-line FL indication is expected to significantly expand its sales. In comparison, Lunsumio, Ordspono, and Monjuvi are expected to reach global sales of approximately $920m, $336m, and $521m, respectively, by 2031.
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