- AbbVie and Genmab plan to ask the Food and Drug Administration to expand use of their dual-acting cancer immunotherapy Epkinly to include patients with a type of blood cancer called follicular lymphoma following positive data in an early-stage trial.
- The drug gained an initial approval in another type of lymphoma in May, and was closely followed by a similar Roche drug called Columvi. New summary results disclosed Tuesday show that most of the follicular lymphoma patients in a Phase 1/2 study responded to treatment, which could enable Epkinly to become available to treat the two most common forms of Non-Hodgkin’s lymphoma.
- However, the agency may wait for more information about the prevalence of a common immune-related side effect known as cytokine release syndrome, or CRS. A dosing study that could help physicians control the incidence and severity of CRS is underway. The FDA may want to see data from that before AbbVie and Genmab file their application, William Blair analyst Matt Phipps wrote in a note to clients.
After years of anticipation, a wave of so-called bispecific antibody drugs have become available for patients with certain blood malignancies. These drugs bind simultaneously to cancer cells and T cells to spur an immune attack against the disease.
In May, Epkinly became the first bispecific drug cleared for use in DLBCL, or diffuse large B-cell lymphoma. But AbbVie and Genmab have been battling a pair of Roche drugs for an early edge. Columvi, for instance, was approved for DLBCL only weeks after Epkinly’s nod, and the FDA sanctioned a second, similar Roche medicine called Lunsumio for follicular lymphoma last December.
AbbVie and Genmab are now hoping Epkinly can compete with Lunsumio.
The data they aim to bring to regulators comes from a cohort of a study called EPCORE NHL-1. Results from that trial were used to support Epkinly’s approval in DLBCL, but the companies also enrolled follicular lymphoma patients whose disease had progressed despite at least two lines of treatment. On Tuesday, they reported that 82% of those patients responded to Epkinly. Genmab and AbbVie didn’t release more details on the drug’s effectiveness, but stated that the response rate “exceeded the protocol prespecified threshold for efficacy.”
Lunsumio had an 80% response rate in a similar population, although comparing drugs across trials is difficult and the two medicines haven’t been tested head to head. Neither has been evaluated against a placebo or active treatment, either, meaning they are only eligible for an “accelerated” approval until the companies complete additional testing.
Bispecifics have been approved to treat some of the same blood cancers that the personalized and logistically complex CAR-T cell therapies are cleared for. In those settings, bispecifics are seen as more convenient alternatives. But, as with CAR-T treatments, they’re associated with CRS, a potentially deadly immune reaction.
AbbVie and Genmab reported that nearly two-thirds of patients taking Epkinly in EPCORE NHL-1 experienced CRS, but just 1.6% of those cases were graded as “severe” or higher, the level at which hospital intervention is necessary. Lunsumio caused CRS in 39% of patients, with 2.5% at grade 3 or higher.
Because bispecifics are mostly administered in doctor’s offices, the FDA has been more cautious about CRS. The agency already requires DLBCL patients receiving their third Epkinly shot, the first full dose, to stay in the hospital for 24 hours afterward. EPCORE NHL-1 has a “dose optimization” component, and the companies said they are “continuing to evaluate alternative step-up dosing regimens to mitigate the risk of CRS.”
In his Tuesday note to clients, Phipps speculated that the companies’ ability to file for approval in follicular lymphoma will depend on the amount of data the FDA needs from that step-up trial.