Frederick Locke, MD, a medical oncologist in the Department of Blood and Marrow Transplant at Moffitt Cancer Center, and an assistant professor of oncology at the University of South Florida, discusses the impact of the ZUMA-1 trial for patients with non-Hodgkin lymphoma (NHL).

In the single-arm ZUMA-1 study, axicabtagene ciloleucel (axi-cel; Yescarta) demonstrated an objective response rate (ORR) of 82% and a complete response (CR) rate of 54%. After 8.7 months of follow-up, 39% of patients remained in CR. The median duration of response in those with a CR was not reached at the time of assessment (95% CI, 8.1-not estimable). The label for the medication lists the objective response rate as 72% and the CR rate as 51% (95% CI, 41%-62%).

Although the pivotal portion of the trial has completed enrollment, Locke says that they will continue to follow patients. These responses are in patients who have no other treatment options. Based on historical data, these patients have a 7% chance of responding to chemotherapy, whereas they are now experiencing a CR of 51%.

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Frederick Locke, MD, a medical oncologist in the Department of Blood and Marrow Transplant at Moffitt Cancer Center, and an assistant professor of Oncology at the University of South Florida, discusses the impact of the ZUMA-1 trial for patients with non-Hodgkin Lymphoma (NHL).

Dr. Locke Discusses the Impact of the ZUMA-1 Trial in NHL

Frederick Locke, MD, a medical oncologist in the Department of Blood and Marrow Transplant at Moffitt Cancer Center, and an assistant professor of Oncology at the University of South Florida, discusses long-term follow-up results of the ZUMA-1 trial for patients with non-Hodgkin lymphoma (NHL).

The FDA has approved the CD19-directed chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adults with relapsed or refractory NHL, based on complete remission (CR) rates in the phase II ZUMA-1 trial.

In the single-arm ZUMA-1 study, axi-cel demonstrated an objective response rate (ORR) of 82% and a CR rate of 54%. After 8.7 months of follow-up, 39% of patients remained in CR. The median duration of response in those with a CR was not reached at the time of assessment (95% CI, 8.1-not estimable). The label for the medication lists the ORR as 72% and the CR rate as 51% (95% CI, 41%-62%).

Dr. Locke Discusses Long-Term Follow-Up of ZUMA-1 Trial for NHL

Frederick Locke, MD, Moffitt Cancer Center, discusses the results of the ZUMA-6 trial investigating axicabtagene ciloleucel (axi-cel; KTE-C19) in combination with atezolizumab (Tecentriq) for the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL).

The ZUMA-6 trial combines axi-cel, the CD19-directed chimeric antigen receptor (CAR) T-cell therapy with atezolizumab. Patients enrolled on the trial have DLBCL and did not respond to their last line of chemotherapy or progressed within 12 months of an autologous hematopoietic stem cell transplant, says Locke.

ZUMA-6 is a phase I/II trial looking at the safety of the combination. The toxicities associated with axi-cel were similar to what was seen in the pivotal ZUMA-1 trial. There were similar rates of cytokine release syndrome and neurotoxicity, explains Locke.

The ZUMA-6 trial is aimed at building on the success of the ZUMA-1 trial, in which the CR rate was 40% with a median follow-up of 15.4 months for patients with refractory, aggressive non-Hodgkin lymphoma treated with axi-cel. Based on initial data from the ZUMA-1 trial, the FDA approved axi-cel in October 2017 as a treatment for adult patients with relapsed or refractory NHL.

Dr. Locke on the ZUMA-6 Trial of Axi-Cel With Atezolizumab for DLBCL

Frederick Locke, MD, Moffitt Cancer Center, discusses the interim results of the phase II pivotal ZUMA-1 trial of the anti-CD19 CAR T-cell therapy KTE-C19 for patients with refractory aggressive non-Hodgkin's lymphoma.

The ZUMA-1 study looked at KTE-C19 for patients with lymphoma that was chemotherapy-refractory or following relapse within 12 months of an autologous transplant. These patients were heavily pretreated with a median of 3 prior treatments but could have received as many as 12 treatment. Of the 111 patients enrolled 101 received therapy. At the time of this interim report, there were 93 patients who had at least 1 month of follow-up. There were 62 patients with ≥3 months of follow-up.

Of the 93 patients, there was a 53% overall response rate (ORR) and a 38% complete response (CR) rate. In those with ≥3 months follow-up, the ORR was 79% and the CR rate was 52%. In those relapsing post transplant (n = 12), the CR was 75%. In those refractory to ≥2 therapies (n = 49), the CR rate was 47%.

View more from the 2017 BMT Tandem Meetings

Fred Locke, MD, Moffitt Cancer Center discusses the interim results of the ZUMA-I trial of Kte-C19, a CAR T-cell therapy.

Dr. Locke on the ZUMA-1 Trial of KTE-C19 for Lymphoma

Frederick Locke, MD, a medical oncologist in the Department of Blood and Marrow Transplant at Moffitt Cancer Center, and an assistant professor of Oncology at the University of South Florida, discusses KTE-C19 for the treatment of refractory aggressive non-Hodgkin lymphoma (NHL).

KTE-C19 is a Kite Pharma—manufactured autologous cell therapy product. After cells are collected from patients with refractory aggressive NHL, they are shipped to the Kite Pharma manufacturing facility and the gene for the chimeric-antigen receptor is inserted into T cells, explains Locke.

Thus far in the ongoing phase I/II ZUMA-1 study, seven patients have received therapy. It was deemed safe.

Eighty-six percent of patients who were treated developed cytokine release syndrome and one patient had grade 4 CRS. One hundred percent of patients developed neurologic toxicities due to KTE-C19 therapy. There was one case of grade 3 and one grade 4 neurologic toxicity.

Seventy-one percent of patients experienced a response, with 4 complete responses and 1 partial response observed, says Locke.

Frederick Locke, MD, a medical oncologist in the Department of Blood and Marrow Transplant at Moffitt Cancer Center, and an assistant professor of Oncology at the University of South Florida, discusses KTE-C19 for the treatment of refractory aggressive non-Hodgkin lymphoma (NHL). 


Frederick Locke, MD

Articles

Dr. Locke Discusses the Impact of the ZUMA-1 Trial in NHL

Dr. Locke Discusses Long-Term Follow-Up of ZUMA-1 Trial for NHL

Dr. Locke on the ZUMA-6 Trial of Axi-Cel With Atezolizumab for DLBCL

Dr. Locke on the ZUMA-1 Trial of KTE-C19 for Lymphoma

Dr. Frederick Locke on KTE-C19 for Refractory NHL