FDA Approves Epkinly for Relapsed/Refractory DLBCL

The Food and Drug Administration (FDA) granted accelerated approval for Epkinly (epcoritamab-bysp) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The approval also includes patients with DLBCL occurring as a result of indolent lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy, according to the FDA’s release.

Of note, Epkinly is a bispecific CD20-directed CD3 T-cell engager.

“The approval of Epkinly in the U.S. is an incredibly important milestone for patients with relapsed or refractory DLBCL who are in need of a new, innovative treatment option administered subcutaneously,” Jan van de Winkel, chief executive officer of Genmab, said in a release from the company.

This FDA approval was based on findings from the EPCORE NHL-1 trial, which included 148 patients with relapsed or refractory DLBCL, all of whom received treatment with Epkinly, according to the release. The main focus of the trial was to assess overall response rate, defined as the proportion of patients with a partial or complete response to treatment with Epkinly.

In this trial, the overall response rate was 61%, with 38% of patients obtaining a complete response, or the disappearance of all signs of cancer in response to treatment, according to the FDA’s release. During a median follow-up of 9.8 months in patients who responded to Epkinly, the estimated median duration of response was 15.6 months.

“Patients with DLBCL who relapse or are refractory to currently available therapies have limited options,” Dr. Tycel Phillips, associate professor in the division of lymphoma at City of Hope in Duarte, California, said in the company’s release. “Generally, the prognosis for these patients is poor, and management of this aggressive disease can be challenging. (Epkinly) is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive (Epkinly) after failure to respond or relapse after two or more prior systemic therapies.”

The prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome, which is a condition that may occur after immunotherapy, during which a rapid release of cytokines in the blood results in different actions throughout the body including fever, headache, nausea, rash, low blood pressure, rapid heartbeat and trouble breathing. There is also a Boxed Warning for life-threatening of fatal immune effector cell-associated neurotoxicity syndrome, another event that may occur from immunotherapy.

The most common side effects that occurred in at least 20% of patients in the trial included fatigue, cytokine release syndrome, injection site reactions, musculoskeletal pain, abdominal pain, fever, diarrhea and nausea.

“Despite recent advances in treating advanced DLBCL, due to the aggressive nature and complexity of the disease, there remains a need for new options that can provide remission, are tolerable and can be administered upon release,” Meghan Gutierrez, chief executive officer of Lymphoma Research Foundation, said in the press release from Genmab. “The approval of Epkinly brings a new option – and with it – new hope to patients and the greater lymphoma community.”

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