Dr. Miklos on Anticipated Sequencing Challenges With KTE-X19 in MCL

David Miklos, MD, associate professor of medicine, Blood and Marrow Transplantation, and clinical director of Cancer Cell Therapy at Stanford University Medical Center, discusses anticipated sequencing challenges with the investigational CAR T-cell therapy KTE-X19 in mantle cell lymphoma (MCL).

In February 2020, the FDA granted a priority review designation to a biologics license application (BLA) for KTE-X19 as a treatment for adult patients with relapsed/refractory MCL based on data from the phase 2 ZUMA-2 trial.

Where the therapeutic modality will best fit into the paradigm has yet to be determined, says Miklos.

The treatment paradigm in MCL includes platinum-based therapies, ibrutinib (Imbruvica)-based therapies, rituximab (Rituxan), autologous stem cell transplant, and venetoclax (Venclexta). As such, it can be difficult to introduce another novel agent into an already crowded armamentarium, explains Miklos.

Additionally, the role of ibrutinib is expanding, and the agent is being tested in many clinical trials, says Miklos.

Though there are other potential settings where this agent could have efficacy, the current BLA submission is for adult patients with relapsed/refractory disease, concludes Miklos.