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Epcoritamab Approved by FDA for Relapsed/Refractory Follicular Lymphoma

• The FDA has granted accelerated approval to epcoritamab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. • The approval was based on the phase 1/2 EPCORE NHL-1 trial, which demonstrated an 82% overall response rate and a 60% complete response rate. • Epcoritamab addresses a significant unmet need in follicular lymphoma, offering a new option with higher response rates compared to existing therapies. • As a bispecific antibody already approved for aggressive lymphomas, epcoritamab's integration into follicular lymphoma treatment is facilitated by existing familiarity among healthcare providers.

The FDA has approved epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This approval, granted on June 26, 2024, is based on data from the phase 1/2 EPCORE NHL-1 trial (NCT03625037) and marks a significant advancement in the treatment landscape for this patient population.
The EPCORE NHL-1 trial demonstrated an impressive overall response rate (ORR) of 82.0% (95% CI, 74.1%-88.2%) and a complete response (CR) rate of 60.0% among 127 patients with relapsed or refractory FL. These results highlight the potential of epcoritamab to address the unmet needs of patients who have exhausted other treatment options.

Unmet Needs in Follicular Lymphoma

According to Dr. Grzegorz S. Nowakowski, consultant in the Division of Hematology at Mayo Clinic Comprehensive Cancer Center, patients with relapsed or refractory FL face significant challenges. Previous treatments, such as PI3K inhibitors, initially showed promise but were later found to have negative effects on overall survival due to increased infection risk, leading to their withdrawal from the market. Other approved agents often yield lower response rates, leaving patients with limited effective options.

Epcoritamab: A New Option

Epcoritamab, a bispecific antibody, offers a novel approach to managing relapsed or refractory FL. Its approval provides a new option to address the limitations of earlier therapies and improve outcomes for these patients. Dr. Nowakowski notes that while some treatments, like bispecific antibodies, show promise, the unmet need persists, making the approval of epcoritamab a welcome advancement.

Familiarity Among Healthcare Providers

Epcoritamab is already FDA-approved for treating patients with aggressive relapsed or refractory lymphomas, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. This existing familiarity among healthcare providers managing these aggressive lymphomas facilitates the adoption and implementation of epcoritamab for patients with FL. Many oncologists and treatment teams are already experienced with the drug’s use, simplifying its integration into the care of patients with relapsed FL.
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Reference News

[1]
Dr Nowakowski on the Implications of the FDA Approval of Epcoritamab in Follicular Lymphoma
onclive.com · Oct 17, 2024

The FDA approved epcoritamab-bysp (Epkinly) as a third-line treatment for relapsed/refractory follicular lymphoma, based...

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