Genmab and AbbVie's EPKINLY (epcoritamab), an IgG1-bispecific antibody (CD3 X CD20) developed with Genmab's DuoBody technology, is administered subcutaneously. It is currently approved as monotherapy for relapsed or refractory (R/R) DLBCL. Combining epcoritamab with diverse antineoplastic agents may enhance clinical outcomes for patients. 

Recently presented at EHA 2024, data from the Phase Ib/II EPCORE NHL-5 study (NCT05283720) evaluated epcoritamab + pola-R-CHP in newly diagnosed DLBCL. As of November 28, 2023, thirty seven patients received this combination. The fixed treatment duration showed robust and lasting responses, with an overall response rate (ORR) of 100% and a complete response rate (CRR) of 89%, consistent across patient subgroups. Median duration of complete response was not reached, and a majority of patients achieving complete response also attained minimal residual disease (MRD) negativity early and sustained it throughout treatment.

Epcoritamab exhibited a manageable safety profile, with no new safety signals identified. Most cytokine release syndrome (CRS) events were low-grade and predictable in timing, resolving without issue. Neutropenia, the most common Grade 3/4 adverse event, occurred in 65% of patients, yet no discontinuations resulted from this and infection rates were low.

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Conclusion

In first-line DLBCL setting, no therapies have provided improved cure rates since the introduction of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R- CHOP). In April 2023, the Food and Drug Administration (FDA) approved POLIVY (Polatuzumab vedotin; Genentech) with a rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) in first-line DLBCL. This approval was based on POLARIX study (NCT03274492). POLIVY in combination with R-CHP (pola-R-CHP) demonstrated improved response rates (ORR- 86% vs. 83.8%, CRR - 78% vs 74%) and improved 2-year progression-free survival rate (77% vs 70.2%) vs. R-CHOP but did not significantly improve overall survival. 

The fixed-duration treatment with epcoritamab combined with pola-R-CHP exhibited significant and long-lasting responses in newly diagnosed DLBCL patients. Importantly, it maintained a manageable safety profile without any new safety concerns identified. Comparatively, data for epcoritamab + first-line standard of care (SoC) were favorable when compared to pola-R-CHP and R-CHOP alone. These findings support further investigation into epcoritamab + pola-R-CHP in newly diagnosed DLBCL patients, underscoring its potential as a promising treatment option in this setting.