FDA Approves Epkinly for Relapsed, Refractory Follicular Lymphoma

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The Food and Drug Administration approved Epkinly, a bispecific T-cell engager, for certain patients with follicular lymphoma.

The Food and Drug Administration (FDA) granted an accelerated an approval to Epkinly (epcoritamab-bysp), a bispecific CD20-directed CD3 T-cell engager, for patients with relapsed or refractory follicular lymphoma who have been previously treated with two or more lines of systemic therapy.

A bispecific T-cell engager (BiTE) is a substance that binds two target proteins on different cells, such as proteins on healthy T-cells (immune cells) and cancer cells, to help destroy cancer cells, according to the National Cancer Institute.

The accelerated approval was based on the phase 1/2 EPCORE NHL-1 study, which included 127 patients with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy, the FDA alert noted.

The study’s primary efficacy and safety analyses were based on a two step-up treatment regimen in the primary group of 127 patients. A separate group of 86 patients receiving three step-up dosing schedule was evaluated for cytokine release mitigation — a reaction that may be severe or life-threatening.

“Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, especially in third-line settings where there is currently no clear standard of care treatment,” said Dr. Jeff Sharman, disease chair, Hematology Research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon, in a news release from Genmab, the a co-manufacturer of Epkinly. “This approval and the durable responses observed in the follicular lymphoma cohort of the EPCORE NHL-1 clinical trial, which reflected a real-world patient population, including patients with difficult-to-treat follicular lymphoma, demonstrate the potential of Epkinly for patients who face limited therapeutic options post-relapse.”

Findings from the phase 1/2 trial showed that the overall response rate (ORR; percentage of patients whose tumors shrunk or disappeared) was 82% in the population with 127 patients, with 60% achieving complete responses (disappearance of cancer).

At an estimated median follow-up of 14.8 months, the median duration of response (DOR; length of time disease responds to treatment without tumor growth) was not reached, meaning not enough patients had disease worsening during this measured period of time. However, the estimated 12-month DOR was 68.4%. The efficacy (how well treatment worked) was similar in the three-step-up dosage group with 86 patients, the alert stated.

“With this approval, patients whose follicular lymphoma has relapsed or is refractory to at least two or more lines of systemic therapy now have the option to be treated with Epkinly, which has demonstrated durable responses without mandatory hospitalization using a three-step-up dosage regimen in this patient population in clinical trials,” said Jan van de Winkel, Chief Executive Officer of Genmab, in the release.

According to the prescribing information, the drug has a Boxed Warning for serious or fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS). ICANS occurred in 6% of patients and serious infections in 40%. In the group of 86 patients receiving the three-step-up dosage, CRS occurred in 49%, in which all events grade 1 (45%) or 2 (9%), meaning they were mild to moderate in severity.

The most common side effects occurring in more than 20% of patients included injection site reactions, CRS, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, itchy skin, cough and headache. Common grade 3 to 4 (severe to life-threatening) side effects occurring in more than 10% of patients included decreased lymphocyte (a type of white blood cell) count, decreased neutrophil (a type of white blood cell) count, decreased white blood cell count and decreased hemoglobin.

“People living with follicular lymphoma are in need of additional options when their cancer returns,” said Lee Greenberger, Chief Scientific Officer at The Leukemia & Lymphoma Society, in Genmab’s news release. “Today’s approval is welcome news for patients, as it provides another tool in the physician arsenal for this difficult-to-treat form of cancer.”

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