Ninety patients out of 148 responded. That is the number at the center of the FDA’s accelerated approval of epcoritamab-bysp, sold as Epkinly, for adults whose diffuse large B-cell lymphoma has come back or stopped responding to treatment. Healio reported the decision on May 19, 2023, citing the drugmakers, Genmab and AbbVie.
The label is specific. It covers adults with DLBCL not otherwise specified, including cases that grew out of a slower-moving lymphoma, and high-grade B-cell lymphoma, once they have been through two or more lines of systemic therapy. It is the first T-cell-engaging bispecific antibody the agency has cleared for this group.
How the drug works
Epkinly is built on Genmab’s DuoBody technology. One arm grabs CD3 on a T cell, the other grabs CD20 on a B cell, and the pairing pushes the T cell to kill the cancerous B cell. Patients get it as an injection under the skin.
“Patients with DLBCL who relapse or are refractory to currently available therapies have limited options,” said Tycel Phillips, MD, of City of Hope, in the release. He added that the prognosis is generally poor and that managing the disease is hard. Meghan Gutierrez, chief executive of the Lymphoma Research Foundation, called the approval “new hope to patients and the greater lymphoma community.”
What the trial showed
The decision rested on EPCORE NHL-1, a phase 2 study of subcutaneous epcoritamab given alone. Of 148 patients with DLBCL or high-grade B-cell lymphoma, 61 percent (90 patients) had a response, and 38 percent (56 patients) reached complete remission. The median duration of response was 15.6 months.
These were not easy cases. The median patient had already tried three earlier therapies, and the range ran from 2 to 11. Eighty-two percent had disease that resisted their last treatment. Eighteen percent had undergone an autologous stem cell transplant, 39 percent had received CAR T-cell therapy, and 29 percent were refractory to CAR T. The larger expansion cohort enrolled 157 patients with large B-cell lymphoma, and 89 percent of the 148 evaluated had DLBCL not otherwise specified.
Risks and the catch
The label carries a boxed warning for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, both potentially life-threatening. Infections and low blood counts, known as cytopenias, are also on the list of serious effects.
Accelerated approval comes with a condition. Continued approval for this use depends on confirmatory trials showing a real clinical benefit.
Sources
- FDA approves Epkinly for treatment of advanced diffuse large B-cell lymphoma
- FDA approves Epkinly for diffuse large B-cell lymphoma – Medthority
