From the FDA Drug Label
The efficacy results are summarized in Table 14 Table 14: Efficacy Results in EPCORE NHL-1 in Patients with DLBCL and High-grade B-cell Lymphoma Endpoint*EPKINLY(N=148) ORR = overall response rate; CI = confidence interval; CR = complete response; PR = partial response; DOR = duration of response; NR = not reached.
- Determined by Lugano criteria (2014) as assessed by independent review committee (IRC) † Early response assessments were evaluated in the context of potential flare reactions. Of 90 patients who achieved an objective response, 9 patients had early flare reactions identified with objective response demonstrated on subsequent imaging per Lugano criteria. ‡ Kaplan-Meier estimate. ORR†, n (%)90 (61) (95% CI)(52.5,68.7) CR, n (%)56 (38) (95% CI)(30.0,46.2) PR, n (%)34 (23) (95% CI)(16. 5,30.6) DOR Median (95% CI), months15.6 (9.7, NR) 9-month estimate‡ % (95% CI)63 (51.5,72.4)
The overall survival is not directly reported in the provided text, however, the duration of response is reported with a median of 15.6 months and a 9-month estimate of 63%.
- Key points:
- Median duration of response: 15.6 months
- 9-month estimate: 63% 1
From the Research
Epcoritamab has demonstrated significant survival benefits in patients with relapsed or refractory large B-cell lymphoma, with an overall response rate of 85% and a complete response rate of 61%, as shown in the most recent study 2. The median duration of complete response and overall survival were 23.6 and 21.6 months, respectively. Key findings from this study include:
- Epcoritamab is administered as a subcutaneous injection with a step-up dosing schedule to mitigate cytokine release syndrome, typically starting at 0.16 mg, increasing to 0.8 mg, then 48 mg, and maintaining at 48 mg every 4 weeks until disease progression or unacceptable toxicity.
- This bispecific antibody works by binding to CD3 on T cells and CD20 on B cells, redirecting T cells to attack malignant B cells.
- Common side effects include cytokine release syndrome (usually mild to moderate), neutropenia, and fatigue.
- Prophylactic measures including corticosteroids, antipyretics, and antihistamines are typically administered before dosing to reduce adverse events.
- Survival outcomes appear most favorable in patients who respond early to treatment, particularly those achieving complete responses, as supported by previous studies 3, 4, 5. However, the most recent and highest quality study 2 provides the most compelling evidence for the use of epcoritamab in this patient population.