According to updated data from the phase II JULIET trial presented at the 2018 ASH Annual Meeting, the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel induced durable responses in previously treated adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Richard Thomas Maziarz, MD, of the Oregon Health & Science Knight Cancer Institute in Portland, presented 19-month follow-up data that included approximately 100 patients with active disease. “These are patients that have a very forlorn prognosis,” he said. “When we look at historical data … we would have predicted a 15 percent to 20 percent survival at two years. We would have predicted a very small percent of patients would be in complete remission (CR) that would be sustained at that timeframe.”
Most of these patients would be offered salvage chemotherapy without an expectation of meaningful survival, according to Dr. Maziarz. “[The study’s] outcomes have changed the landscape of how we’re going to treat these patients going forward,” he said.
The trial found that 40% of patients were alive at follow-up and responses are durable: There was a 54% response rate, a 40% CR rate, and a 14% partial remission (PR) rate. Some patients with PRs went on to achieve CRs, said Dr. Maziarz.
“There’s a huge excitement [about CAR T-cell therapies],” he said. However, currently, CAR T-cell therapies are limited to mainly academic centers or highly supported community research centers, meaning many patients have to travel for therapy, said Dr. Maziarz. “I think community oncologists certainly want the therapies to be developed to a point where they can [be administered] locally,” he said. “I would endorse that as the goal of [CAR T-cell] therapy.”
Tisagenlecleucel is an anti-CD19 CAR T-cell therapy approved by the U.S. Food and Drug Administration for the treatment of patients ≤25 years of age with relapsed/refractory B-cell precursor acute lymphocytic leukemia. Tisagenlecleucel is also approved to treat DLBCL, high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma in those who have received two or more lines of systemic therapy.