FDA gives accelerated approval to Epkinly for advanced follicular lymphoma
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The FDA granted accelerated approval to epcoritamab-bysp for the treatment of adults with relapsed or refractory follicular lymphoma who have received two or more previous lines of therapy.
Epcoritamab-bysp (Epkinly; Genmab, AbbVie) — a bispecific CD20-directed CD3 T-cell engager — received priority review and orphan drug designation from the FDA for the indication. The agent received previous approval for adults with relapsed or refractory diffuse large B-cell lymphoma after two previous lines of therapy.
FDA based accelerated approval on results from the open-label EPCORE NHL-1 trial. The single-arm phase 2 study assessed the efficacy and safety of epcoritamab in 127 adults with relapsed or refractory follicular lymphoma who had received at least two lines of systemic therapy.
The 127 patients who received a two-step-up dosing regimen comprised the primary efficacy and safety population, whereas a separate dose optimization cohort of 86 patients evaluated the recommended three-step-up dosage schedule for cytokine release syndrome mitigation.
Overall response rate and duration of response served as the study’s main efficacy outcome measurements.
Results showed an overall response rate of 82% (95% CI, 74.1-88.2) for the 127 patients in the primary efficacy population, with 60% achieving complete responses.
At an estimated median follow-up of 14.8 months among treatment responders, median duration of response had not been reached, with a 12-month Kaplan-Meier estimate for duration of response of 68.4% (95% CI, 57.6-77).
Study investigators reported similar efficacy in the 86 patients who received the three-step-up dosage schedule.
"Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, and there is currently no clear standard-of-care treatment available across practice settings," Jeff Sharman, MD, disease chair of hematology research at Sarah Cannon Research Institute at Willamette Valley Cancer Institute, said in an AbbVie-issued press release. "The responses observed in the follicular lymphoma cohort of the EPCORE NHL-1 clinical trial, as well as in patients with relapsed or refractory [diffuse large B-cell lymphoma] from the trial, show the potential of Epkinly to serve as an important treatment option for these patients."
Adverse events occurring in at least 20% of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough and headache.
Grade 3 to grade 4 laboratory abnormalities occurring in at least 10% of patients included decreases in lymphocyte count, neutrophil count, white blood cell count and hemoglobin.
The recommended regimen, according to researchers, consists of epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity.
FDA is requiring verification of epcoritamab’s clinical benefits before converting to regular approval via a phase 3 randomized trial. The study is currently enrolling patients and will evaluate rituximab and lenalidomide alone or in combination with epcoritamab in adults with relapsed or refractory follicular lymphoma.
References:
- FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma?utm_medium=email&utm_source=govdelivery. Published June 26, 2024. Accessed June 27, 2024.
- U.S. Food and Drug Administration grants second approval for Epkinly (epcoritamab-bysp) to treat patients with relapsed or refractory follicular lymphoma (press release). Available at: https://news.abbvie.com/2024-06-26-U-S-Food-and-Drug-Administration-Grants-Second-Approval-for-EPKINLY-R-epcoritamab-bysp-to-Treat-Patients-with-Relapsed-or-Refractory-Follicular-Lymphoma. Published June 26, 2024. Accessed June 27, 2024.
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