AbbVie shared topline findings from the Phase 3 EPCORE DLBCL-1 trial, which evaluated epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, against investigator-chosen chemoimmunotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma. The study showed that epcoritamab improved progression-free survival with a hazard ratio of 0.74 and a 95 percent confidence interval ranging from 0.60 to 0.92. Patients treated with epcoritamab also experienced higher complete response rates, longer duration of response, and extended time to next treatment. The trial did not show a statistically significant improvement in overall survival with a hazard ratio of 0.96 and a 95 percent confidence interval of 0.77 to 1.20.
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EPCORE DLBCL-1 is the first Phase 3 study to show improved progression-free survival with a CD3xCD20 T-cell engaging bispecific monotherapy in patients with relapsed or refractory DLBCL. The global trial enrolled 483 patients who had at least one prior therapy, with 73 percent having received two or more previous lines of treatment, and all were ineligible for high-dose chemotherapy and autologous stem cell transplant.
The safety profile observed was consistent with what is already known about epcoritamab. AbbVie and Genmab are reviewing potential influences on the data, including the COVID-19 pandemic, which coincided with the study period during the Omicron variant surge, and the increasing availability of new lymphoma therapies. The results will be submitted for presentation at a future medical meeting, and regulatory discussions with authorities globally will determine the next steps.
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Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma worldwide, representing roughly 25 to 30 percent of all cases. In the United States, about 25,000 new cases are diagnosed each year. DLBCL can develop in lymph nodes or in organs outside the lymphatic system, occurs more often in older adults, and is slightly more common in men. It is a fast-growing lymphoma affecting B-cell lymphocytes, a type of white blood cell. Many patients experience relapsed disease, which returns after treatment, or refractory disease, which does not respond to therapy. Despite advances, managing DLBCL remains a challenge.
Epcoritamab, marketed as EPKINLY in the U.S. and Japan and TEPKINLY in the European Union, has received regulatory approval for certain lymphoma indications in more than 65 countries. AbbVie and Genmab continue to advance clinical development of epcoritamab, testing it both as a single agent and in combination regimens across multiple treatment lines and in various hematologic malignancies.
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3, open-label, multi-center, randomized study comparing epcoritamab to investigator-chosen chemotherapy, either rituximab plus gemcitabine plus oxaliplatin or bendamustine plus rituximab, in adult patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant. The study began on January 13, 2021, and is ongoing.
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