Source – Abbvie
On 28 June 2023, AbbVie in collaboration with Genmab, disclosede the initial findings of the Phase I/II EPCORE NHL-1 clinical trial, focusing on the cohort of patients with follicular lymphoma (FL). The trial examined the efficacy and safety of epcoritamab, an investigational bispecific antibody that engages T-cells and is administered subcutaneously. The study involved 128 adult patients who had relapsed or refractory FL and had received two or more lines of systemic therapy. Notably, 70.3 percent of the patients had become refractory to both an anti-CD20 monoclonal antibody and an alkylating agent. Epcoritamab is a joint development effort between AbbVie and Genmab as part of their oncology collaboration.
“The topline results of the trial are promising and provide further support for epcoritamab as a potential treatment option for patients with relapsed or refractory follicular lymphoma. Expressed encouragement regarding the results and emphasized the potential of epcoritamab as a core therapy for individuals with B-cell malignancies.”
– Dr. Mariana Cota Stirner, Vice President and Therapeutic Area Head for Hematology at AbbVie
The EPCORE NHL-1 trial is an open-label study consisting of three parts: a Phase I dose escalation part, a Phase IIa expansion part, and a Phase IIa optimization part. The topline results from this particular cohort exhibited an overall response rate (ORR) of 82 percent, as confirmed by an independent review committee (IRC), surpassing the predetermined efficacy threshold outlined in the protocol. The median duration of response (DOR) was not reached during the analysis, necessitating further follow-up. The median number of previous therapy lines in this cohort was three (ranging from two to four lines).
No new safety concerns emerged during the trial analysis of epcoritamab. The most common treatment-emergent adverse event was cytokine release syndrome (CRS), occurring in 66.4 percent of patients (with 1.6 percent classified as Grade III or higher). The ongoing optimization part of the trial aims to explore alternative step-up dosing regimens to mitigate the risk of CRS, and preliminary data are encouraging in this regard.
The EPCORE NHL-1 trial is a multi-center study evaluating the safety and preliminary efficacy of epcoritamab, specifically designed for adult patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL). The Phase IIa expansion part of the trial includes additional patients in three cohorts with different types of relapsed or refractory B-cell NHL, providing further insights into the safety and efficacy of epcoritamab for patients with limited treatment options. The dose optimization part aims to assess alternative step-up dosing regimens to minimize Grade 2 CRS and mitigate Grade ≥3 cytokine release syndrome. The primary endpoint of the expansion part is the overall response rate, as evaluated by an independent review committee. Secondary efficacy endpoints include duration of response, complete response rate, duration of complete response, progression-free survival, and time to response based on the Lugano criteria. Secondary efficacy endpoints also encompass overall survival, time to next therapy, and the rate of minimal residual disease negativity.