Kite's CAR-T Therapy Produces Durable Remission in DLBCL, Study Finds

A study on long-term remission of diffuse large B-cell lymphoma (DLBCL) shows that Kite Pharma’s anti-CD19 chimeric antigen receptor-T (CAR-T) cell treatment resulted in remission for up to 56 months.

The research, to be published in Molecular Therapy, followed 7 evaluable patients with relapsed DLBCL, a type of non-Hodgkin lymphoma (NHL), who received the anti-CD19 CAR-T cells. Of these patients, 5 demonstrated complete remission (CR), and in 4 these remissions were durable long-term.

At the time of publication, these 4 patients had achieved CRs of 56, 51, 44, and 38 months’ duration, and none had relapsed.

“We are encouraged to see durable CRs ongoing for more than 3 years, which raises a possibility of cure, from a single infusion of anti-CD19 CAR-T cells in patients with chemorefractory DLBCL, a population that previously had no curative treatment options,” said Kite’s chief medical officer, David Chang, MD, PhD, in a press statement.

The trial, which was led by researchers from the National Cancer Institute’s Center for Cancer Research, found a low incidence of severe infections due to the CAR-T therapy “despite long periods of B-cell depletion and hypogammaglobulinemia.” Among the 4 patients who achieved long-term CR, only 1 was hospitalized for an infection.

CAR-T therapy works by killing malignant and normal B cells, but the study found that remission continued in 3 of 4 patients with CR even after recovery of non-malignant B cells. This “demonstrated that remissions of DLBCL can continue after disappearance of functionally-effective anti-CD19 CAR T-cell populations,” the researchers wrote.

The study was a follow-up to results published in the Journal of Clinical Oncology in 2015, when the researchers were the first to report CRs in chemotherapy-refractory DLBCL with the use of anti-CD19 CAR-T therapy. At the time, the study authors wrote that the findings “should strongly encourage continued development” of such therapies.

Drug developers appear to have taken that encouragement to heart, as CAR-T therapies have emerged as a potential game-changer in the immunotherapy landscape. Recently, the FDA’s Oncologic Advisory Committee unanimously decided to give the green light to Novartis’s CAR-T treatment CTL019 for relapsed or refractory B-cell acute lymphoblastic leukemia, paving the way for it to be approved by the FDA as soon as October.

In May 2017, Kite’s CAR-T therapy received priority review status from the FDA, and it had been designated a Breakthrough Therapy for DLBCL and 2 other lymphomas since December 2015. The results from the recent study, in which DLBCL patients experienced CR for as long as 56 months, add to the evidence supporting the promise of CAR-T therapy.

“This study helps us to understand the long-term potential for this anti-CD19 CAR-T cell therapy (axicabtagene ciloleucel) in the larger aggressive NHL patient population,” said Chang in the statement.