Tisagenlecleucel in Stubborn Form of Lymphoma Shows Sustained Responses

High response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) six months after receiving a single dose of tisagenlecleucel, a CAR T-cell therapy that targets CD-19, according to researchers.

This latest interim analysis of the international JULIET trial showed that for 46 patients with at least 6 months of follow-up, the overall response rate was 37%, with 30% achieving a complete response and 7% achieving a partial response. This observation indicates that, among 81 patients treated, those whose signs of cancer had gone away at 3 months, remained relapse-free at 6 months and beyond.

 

 

While we don’t completely understand why these remissions are so durable, it’s exciting and will change how this disease is treated when conventional therapies fail. We are going to be able to offer patients who don’t respond to standard therapies a form of therapy that may, after a single treatment, relieve symptoms and save lives.”

Lead study author Stephen Schuster, MD, Professor of Haematology/Oncology in the Perelman School of Medicine at the University of Pennsylvania (Penn) and Penn's Abramson Cancer Center

This single-arm, open-label Phase II trial is the largest study examining a CAR T-cell therapy exclusively in people with DLBCL. It is being conducted at 27 sites spanning 10 countries across North America, Europe, Australia, and Asia. Participants had received two or more lines of prior chemotherapy and had disease progression, or had failed to respond or were ineligible for autologous stem cell transplant. Patients ranged from 22 to 76 years old.

Subgroup analyses showed no difference in outcomes based on prior DLBCL treatment or risk factors. Of the 81 patients included in JULIET, the responding patients continue to be followed without any additional therapy, and median durable overall response and overall survival have yet to be reached.

Most of the adverse events were seen shortly after infusion and included CRS and neurotoxicities. There were no deaths attributable to CTL019, CRS, or neurological events.

 

 

Once the CAR T cells were generated, we could freeze them again, allowing us to hold the product until patients were clinically ready to receive them,” he said. “These are very sick patients, so this gives the treating physician some flexibility to schedule therapy when it’s best for each patient.

Stephen Schuster, MD

Patients in the JULIET trial who responded to therapy continue to be followed carefully for recurrence of their lymphoma and recovery of their immune system.