Genmab’s EPCORE NHL-6 Trial: A Paradigm Shift in Outpatient Bispecific Therapy for R/R DLBCL

The recent updates from Genmab’s Phase 2 EPCORE NHL-6 trial (NCT05451810) have positioned epcoritamab (Epkinly) as a transformative force in the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By demonstrating the feasibility of outpatient administration for the first full dose of this subcutaneous bispecific antibody, the trial challenges traditional inpatient monitoring paradigms and underscores Genmab’s potential to reshape hematologic oncology. For investors, the implications are clear: Genmab’s collaboration with AbbVie and its innovative therapeutic approach could drive long-term growth in a rapidly evolving market.

Outpatient Feasibility and Clinical Efficacy

The EPCORE NHL-6 trial enrolled 92 patients with R/R DLBCL who had received at least one prior line of therapy. Of the 88 patients who received the first full dose (48 mg) of epcoritamab, 92% were treated in outpatient settings, with 70% of these patients experiencing no cytokine release syndrome (CRS) [1]. Adverse events that did occur—such as CRS (30% in the outpatient group) and immune cell-associated neurotoxicity syndrome (ICANS, 7.6% overall)—were predominantly low-grade (Grade 1–2) and resolved within days [1]. This safety profile, combined with an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6% in patients with one prior therapy, highlights epcoritamab’s therapeutic potential [1].

The ability to administer epcoritamab in outpatient settings is a critical differentiator. Traditional bispecific antibodies for R/R DLBCL often require inpatient monitoring due to the risk of severe CRS or ICANS. By reducing the need for hospitalization, epcoritamab not only lowers healthcare costs but also improves patient quality of life—a factor increasingly prioritized in value-based care models [1].

Market Dynamics and Competitive Positioning

The global bispecific antibody market is projected to grow at a compound annual growth rate (CAGR) of 44.2%, reaching $484.88 billion by 2034 [4]. Within this landscape, Genmab’s epcoritamab stands out for its subcutaneous delivery, which offers logistical advantages over intravenous competitors like Roche’s Columvi. Analysts estimate epcoritamab’s annual sales could reach $3.94 billion by 2031, driven by label expansions and combination therapies [4].

The EPCORE NHL-6 trial’s success is further bolstered by Genmab’s broader pipeline. For instance, the Phase 3 EPCORE FL-1 trial in follicular lymphoma (FL) demonstrated a statistically significant improvement in ORR (95.7%) and progression-free survival (PFS) when epcoritamab was combined with rituximab and lenalidomide (R2) [5]. This combination therapy is under FDA priority review, with a target action date of November 30, 2025 [5]. If approved, it would mark the first bispecific antibody regimen for second-line R/R FL, expanding Genmab’s market footprint.

Strategic Partnerships and Regulatory Timelines

Genmab’s partnership with AbbVie is pivotal to its growth trajectory. AbbVie’s commercial infrastructure and Genmab’s bispecific antibody expertise create a synergistic platform for scaling epcoritamab’s adoption. The duo is also advancing label expansions into earlier lines of therapy, a move that could capture a larger share of the DLBCL market, which is projected to grow at a CAGR of 7.5% through 2031 [3].

However, regulatory hurdles remain. While the EPCORE NHL-6 trial’s outpatient findings are promising, the U.S. FDA has not yet approved epcoritamab for outpatient use in the second-line setting [1]. Investors must monitor the regulatory landscape closely, as approval could accelerate adoption and differentiate Genmab from competitors.

Long-Term Growth Potential

Genmab’s long-term prospects hinge on three pillars: therapeutic innovation, market access, and strategic execution. The EPCORE NHL-6 trial’s outpatient findings align with industry trends favoring decentralized care models, which are expected to reduce healthcare costs by up to 30% in oncology settings [6]. Additionally, epcoritamab’s subcutaneous administration simplifies logistics for community-based clinics, enhancing its appeal in geographies with limited infrastructure.

From a financial perspective, the U.S. bispecific antibody market alone is projected to grow from $12.2 billion in 2025 to $40.5 billion by 2029 [6]. Genmab’s ability to capture a significant portion of this growth will depend on its capacity to secure favorable reimbursement terms and demonstrate cost-effectiveness relative to alternatives like CAR-T therapies.

Conclusion

Genmab’s EPCORE NHL-6 trial represents more than a clinical milestone—it signals a paradigm shift in how R/R DLBCL is managed. By enabling outpatient administration without compromising safety or efficacy, epcoritamab addresses unmet needs in a market ripe for disruption. For investors, the combination of Genmab’s innovative pipeline, AbbVie’s commercial strength, and the bispecific antibody market’s explosive growth potential makes a compelling case for long-term investment. However, success will require navigating regulatory uncertainties and staying ahead of a competitive landscape where over 250 bispecific antibody therapies are in development [1].

Source:
[1] Genmab Announces Updated Results from Phase 2 EPCORE® NHL-6 Trial [https://ir.genmab.com/news-releases/news-release-details/genmab-announces-updated-results-phase-2-epcorer-nhl-6-study]
[2] Assessing the Investment Potential of Outpatient Bispecific ... [https://www.ainvest.com/news/assessing-investment-potential-outpatient-bispecific-antibody-therapy-hematology-2509/]
[3] Diffuse Large B-cell Lymphoma Therapeutics Market Size [https://www.datamintelligence.com/research-report/diffuse-large-b-cell-lymphoma-therapeutics-market]
[4] Bispecific Antibodies Market Size and Forecast 2025 to 2034 [https://www.precedenceresearch.com/bispecific-antibodies-market]
[5] Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints [https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual]
[6] Oncology Insights: June 2025 [https://www.primetherapeutics.com/oncology-insights-june-2025]