Genmab's EPCORE NHL-6 Trial: Outpatient Bispecific Therapy as a Game-Changer in R/R DLBCL Treatment

The recent results from Genmab’s Phase 2 EPCORE NHL-6 trial have redefined the therapeutic and commercial landscape for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Epcoritamab, a T-cell-engaging bispecific antibody (BsAb), demonstrated an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6% in patients with one prior line of therapy, with similarly robust outcomes in those with two or more prior lines (ORR: 60.0%, CR: 38.0%) [1]. These results, combined with the drug’s outpatient administration model, position it as a transformative force in hematology, offering both clinical efficacy and cost efficiency.

Clinical Efficacy and Safety: A Dual Win

Epcoritamab’s ability to achieve high response rates in an outpatient setting is a critical differentiator. According to a report by Genmab, 92% of patients received the first full dose of epcoritamab without requiring inpatient monitoring [2]. Adverse events, including cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS), were predominantly low-grade and resolved rapidly—median durations of 2 and 3 days, respectively [1]. This safety profile not only enhances patient quality of life but also reduces healthcare system burdens, a factor increasingly prioritized by payers and providers.

Competitive Edge: Subcutaneous vs. Intravenous Therapies

The outpatient model of epcoritamab contrasts sharply with intravenous BsAbs like Roche’s Columvi, which necessitate inpatient monitoring due to higher CRS rates (64.3%) and prolonged hospital stays [3]. As stated by analysts at AInvest, epcoritamab’s subcutaneous administration reduces healthcare costs by up to 40% compared to intravenous alternatives, making it a preferred option for both patients and healthcare systems [4]. This advantage is further amplified by its potential for combination therapies. For instance, epcoritamab combined with GemOx achieved an ORR of 85% and a CR rate of 61% in transplant-ineligible patients, with median durations of response exceeding 23 months [5].

Market Potential and Financial Projections

The bispecific antibody market is poised for explosive growth, with the U.S. segment projected to expand from $12.2 billion in 2025 to $40.5 billion by 2029 [4]. Epcoritamab is uniquely positioned to capture a significant share of this growth. Data from AbbVie and Genmab indicate that the drug generated $211 million in sales during the first half of 2025, with analysts forecasting annual sales of $3.94 billion by 2031, driven by label expansions into earlier lines of therapy and new indications like follicular lymphoma [6].

Strategic Partnerships and Long-Term Outlook

Genmab’s collaboration with AbbVie has been instrumental in accelerating epcoritamab’s development and commercialization. AbbVie’s global infrastructure ensures rapid market penetration, while Genmab’s expertise in BsAb innovation maintains a first-mover advantage. Long-term data from the EPCORE NHL-3 and NHL-1 trials further reinforce confidence, showing durable remissions over three years in 56% and 47% of patients, respectively [7]. These outcomes suggest epcoritamab could become a standard of care in R/R DLBCL, particularly as it expands into combination regimens and earlier treatment lines.

Conclusion: A Compelling Investment Thesis

Epcoritamab’s clinical success, outpatient model, and favorable safety profile create a compelling value proposition for investors. With a projected CAGR of 17.8% for the global BsAb market and epcoritamab’s potential to dominate key indications, the investment case is further strengthened by its alignment with industry trends toward decentralized care and cost efficiency. As Genmab and AbbVie continue to explore label expansions and combination therapies, epcoritamab stands as a cornerstone of the next-generation hematology treatment paradigm.

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] AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study [https://news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL]
[3] Assessing the Investment Potential of Outpatient Bispecific ... [https://www.ainvest.com/news/assessing-investment-potential-outpatient-bispecific-antibody-therapy-hematology-2509/]
[4] Bispecific Antibodies Market Size and Forecast 2025 to 2034 [https://www.precedenceresearch.com/bispecific-antibodies-market]
[5] Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial [https://pubmed.ncbi.nlm.nih.gov/39792928/]
[6] EHA 2025: Genmab and AbbVie's Epkinly outpaces BiTE [https://www.clinicaltrialsarena.com/analyst-comment/eha-2025-genmab-abbvie-epkinly-dlbcl/]
[7] Epcoritamab Maintains Responses at 3 Years in Relapsed/Refractory LBCL [https://www.onclive.com/view/epcoritamab-maintains-responses-at-3-years-in-relapsed-refractory-lbcl]