AbbVie (ABBV) and Genmab A/S (GMAB) released results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a subcutaneously administered, T-cell engaging bispecific antibody, versus investigator's choice of chemoimmunotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The study demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with epcoritamab. Additional benefits were observed in complete response rates (CRR), duration of response (DoR), and time to next treatment, underscoring the therapy's potential clinical impact.
Importantly, the trial did not demonstrate a statistically significant improvement in overall survival (OS). This outcome highlights the need for further investigation to fully understand the long-term benefits of epcoritamab in relapsed/refractory DLBCL..
EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT).
AbbVie and Genmab said that they are working to assess the potential impact of various factors, including the COVID-19 pandemic and the increased availability of novel anti-lymphoma therapies during the study timeline. The data will be submitted for presentation at a future medical meeting, and AbbVie and Genmab will engage global regulatory authorities to determine next steps.
Epcoritamab has received regulatory approval in certain lymphoma indications in more than 65 countries. AbbVie and Genmab remain committed to advancing epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies.
ABBV closed Friday's regular trading session at $214.35, down $0.67 or 0.31%. In after-hours trading, the stock edged slightly higher to $214.66, a gain of $0.31 or 0.15% by 8:00 PM EST
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