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, according to phase 2 study results presented at the annual meeting of the American Society of Hematology, held virtually this year.
The overall response rate exceeded 90% in the ZUMA-5 study, which included patients with multiply relapsed follicular lymphoma (FL) or marginal zone lymphoma (MZL) who were treated with this anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
“Although longer follow-up is needed, these responses appear to be durable,” said investigator Caron Jacobson, MD, of Dana-Farber Cancer Institute in Boston.
Complete responses (CRs) after axi-cel treatment were seen in about three-quarters of patients, and most of those patients were still in response with a median follow-up that approached 1.5 years as of this report at the ASH meeting.
In her presentation, Dr. Jacobson said the safety profile of axi-cel in ZUMA-5 was manageable and “at least similar” to what was previously seen in aggressive relapsed lymphomas, referring to the ZUMA-1 study that led to 2017 approval by the Food and Drug Administration of the treatment for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
The FL patient cohort in ZUMA-5 appeared to have lower rates of cytokine release syndrome (CRS) and high-grade neurotoxicity, compared with the MZL cohort in the study, she added.
Catherine Bollard, MD, of Children’s National Research Institute in Washington, said these results suggest axi-cel may be a “viable treatment option” for some patients with indolent lymphomas who have not responded to other therapies.
“What the field does need is long-term follow-up in the real-world setting to see what the true progression-free and disease-free survival is for these patients,” said Dr. Bollard, who moderated a media briefing that included the ZUMA-5 study.
“It’s really exciting to see this data in the [indolent] lymphoma setting, and I actually would like to see it moved further up in the treatment of patients, earlier in their disease process, if that’s going to be possible,” she added.
Promising results
The report on ZUMA-5, presented by Dr. Jacobson, involved 146 patients with relapsed/refractory indolent NHL: 124 patients with FL and an exploratory cohort of 22 patients with MZL. All patients had received at least two prior lines of therapy.
Following a fludarabine/cyclophosphamide conditioning regimen, patients received axi-cel at the FDA-approved dose of 2 x 106 CAR-positive T cells per kg of body weight. The primary endpoint of the study was overall response rate (ORR).
For 104 patients evaluable for efficacy, the ORR was 92% (96 patients), including CR in 76% (79 patients), data show. Among 84 FL patients evaluable for efficacy, ORR and CR were 94% (79 patients) and 80% (67 patients), respectively, while among 20 evaluable patients in the exploratory MZL cohort, ORR and CR were 60% (12 patients) and 25% (5 patients), respectively.
Sixty-four percent of patients with FL had an ongoing response at a median follow-up of 17.5 months, according to Dr. Jacobson, who added that median duration of response (DOR) had not been reached, while the 12-month DOR rate approached 72%.
The 12-month progression-free survival and overall survival rates were 73.7% and 92.9%, respectively, with medians not yet reached for either survival outcome, according to reported data.
Adverse effects
The incidence of grade 3 or greater neurologic events was lower in FL patients (15%), compared with MZL patients (41%), according to Dr. Jacobson.
While CRS occurred in 82% of patients, rates of grade 3 or greater CRS occurred in just 6% of FL patients and 9% of MZL patients, the investigator said.
There were no grade 5 neurologic events, and one grade 5 CRS was observed, she noted in her presentation.
The median time to onset of CRS was 4 days, compared with 2 days in the ZUMA-1 trial. “This may have implications for the possibility of outpatient therapy,” she said.
A study is planned to look at outpatient administration of axi-cel in patients with indolent NHL, she added.
Dr. Jacobson said she had no conflicts of interest to declare. Coauthors reported disclosures related to Kite, a Gilead Company; Genentech; Epizyme; Verastem; Novartis; and Pfizer, among others.
Correction, 12/7/20: An earlier version of this article misattributed some aspects of the ZUMA-5 trial to ZUMA-1.
SOURCE: Jacobson CA et al. ASH 2020, Abstract 700.
, according to phase 2 study results presented at the annual meeting of the American Society of Hematology, held virtually this year.
The overall response rate exceeded 90% in the ZUMA-5 study, which included patients with multiply relapsed follicular lymphoma (FL) or marginal zone lymphoma (MZL) who were treated with this anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
“Although longer follow-up is needed, these responses appear to be durable,” said investigator Caron Jacobson, MD, of Dana-Farber Cancer Institute in Boston.
Complete responses (CRs) after axi-cel treatment were seen in about three-quarters of patients, and most of those patients were still in response with a median follow-up that approached 1.5 years as of this report at the ASH meeting.
In her presentation, Dr. Jacobson said the safety profile of axi-cel in ZUMA-5 was manageable and “at least similar” to what was previously seen in aggressive relapsed lymphomas, referring to the ZUMA-1 study that led to 2017 approval by the Food and Drug Administration of the treatment for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
The FL patient cohort in ZUMA-5 appeared to have lower rates of cytokine release syndrome (CRS) and high-grade neurotoxicity, compared with the MZL cohort in the study, she added.
Catherine Bollard, MD, of Children’s National Research Institute in Washington, said these results suggest axi-cel may be a “viable treatment option” for some patients with indolent lymphomas who have not responded to other therapies.
“What the field does need is long-term follow-up in the real-world setting to see what the true progression-free and disease-free survival is for these patients,” said Dr. Bollard, who moderated a media briefing that included the ZUMA-5 study.
“It’s really exciting to see this data in the [indolent] lymphoma setting, and I actually would like to see it moved further up in the treatment of patients, earlier in their disease process, if that’s going to be possible,” she added.
Promising results
The report on ZUMA-5, presented by Dr. Jacobson, involved 146 patients with relapsed/refractory indolent NHL: 124 patients with FL and an exploratory cohort of 22 patients with MZL. All patients had received at least two prior lines of therapy.
Following a fludarabine/cyclophosphamide conditioning regimen, patients received axi-cel at the FDA-approved dose of 2 x 106 CAR-positive T cells per kg of body weight. The primary endpoint of the study was overall response rate (ORR).
For 104 patients evaluable for efficacy, the ORR was 92% (96 patients), including CR in 76% (79 patients), data show. Among 84 FL patients evaluable for efficacy, ORR and CR were 94% (79 patients) and 80% (67 patients), respectively, while among 20 evaluable patients in the exploratory MZL cohort, ORR and CR were 60% (12 patients) and 25% (5 patients), respectively.
Sixty-four percent of patients with FL had an ongoing response at a median follow-up of 17.5 months, according to Dr. Jacobson, who added that median duration of response (DOR) had not been reached, while the 12-month DOR rate approached 72%.
The 12-month progression-free survival and overall survival rates were 73.7% and 92.9%, respectively, with medians not yet reached for either survival outcome, according to reported data.
Adverse effects
The incidence of grade 3 or greater neurologic events was lower in FL patients (15%), compared with MZL patients (41%), according to Dr. Jacobson.
While CRS occurred in 82% of patients, rates of grade 3 or greater CRS occurred in just 6% of FL patients and 9% of MZL patients, the investigator said.
There were no grade 5 neurologic events, and one grade 5 CRS was observed, she noted in her presentation.
The median time to onset of CRS was 4 days, compared with 2 days in the ZUMA-1 trial. “This may have implications for the possibility of outpatient therapy,” she said.
A study is planned to look at outpatient administration of axi-cel in patients with indolent NHL, she added.
Dr. Jacobson said she had no conflicts of interest to declare. Coauthors reported disclosures related to Kite, a Gilead Company; Genentech; Epizyme; Verastem; Novartis; and Pfizer, among others.
Correction, 12/7/20: An earlier version of this article misattributed some aspects of the ZUMA-5 trial to ZUMA-1.
SOURCE: Jacobson CA et al. ASH 2020, Abstract 700.
, according to phase 2 study results presented at the annual meeting of the American Society of Hematology, held virtually this year.
The overall response rate exceeded 90% in the ZUMA-5 study, which included patients with multiply relapsed follicular lymphoma (FL) or marginal zone lymphoma (MZL) who were treated with this anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
“Although longer follow-up is needed, these responses appear to be durable,” said investigator Caron Jacobson, MD, of Dana-Farber Cancer Institute in Boston.
Complete responses (CRs) after axi-cel treatment were seen in about three-quarters of patients, and most of those patients were still in response with a median follow-up that approached 1.5 years as of this report at the ASH meeting.
In her presentation, Dr. Jacobson said the safety profile of axi-cel in ZUMA-5 was manageable and “at least similar” to what was previously seen in aggressive relapsed lymphomas, referring to the ZUMA-1 study that led to 2017 approval by the Food and Drug Administration of the treatment for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
The FL patient cohort in ZUMA-5 appeared to have lower rates of cytokine release syndrome (CRS) and high-grade neurotoxicity, compared with the MZL cohort in the study, she added.
Catherine Bollard, MD, of Children’s National Research Institute in Washington, said these results suggest axi-cel may be a “viable treatment option” for some patients with indolent lymphomas who have not responded to other therapies.
“What the field does need is long-term follow-up in the real-world setting to see what the true progression-free and disease-free survival is for these patients,” said Dr. Bollard, who moderated a media briefing that included the ZUMA-5 study.
“It’s really exciting to see this data in the [indolent] lymphoma setting, and I actually would like to see it moved further up in the treatment of patients, earlier in their disease process, if that’s going to be possible,” she added.
Promising results
The report on ZUMA-5, presented by Dr. Jacobson, involved 146 patients with relapsed/refractory indolent NHL: 124 patients with FL and an exploratory cohort of 22 patients with MZL. All patients had received at least two prior lines of therapy.
Following a fludarabine/cyclophosphamide conditioning regimen, patients received axi-cel at the FDA-approved dose of 2 x 106 CAR-positive T cells per kg of body weight. The primary endpoint of the study was overall response rate (ORR).
For 104 patients evaluable for efficacy, the ORR was 92% (96 patients), including CR in 76% (79 patients), data show. Among 84 FL patients evaluable for efficacy, ORR and CR were 94% (79 patients) and 80% (67 patients), respectively, while among 20 evaluable patients in the exploratory MZL cohort, ORR and CR were 60% (12 patients) and 25% (5 patients), respectively.
Sixty-four percent of patients with FL had an ongoing response at a median follow-up of 17.5 months, according to Dr. Jacobson, who added that median duration of response (DOR) had not been reached, while the 12-month DOR rate approached 72%.
The 12-month progression-free survival and overall survival rates were 73.7% and 92.9%, respectively, with medians not yet reached for either survival outcome, according to reported data.
Adverse effects
The incidence of grade 3 or greater neurologic events was lower in FL patients (15%), compared with MZL patients (41%), according to Dr. Jacobson.
While CRS occurred in 82% of patients, rates of grade 3 or greater CRS occurred in just 6% of FL patients and 9% of MZL patients, the investigator said.
There were no grade 5 neurologic events, and one grade 5 CRS was observed, she noted in her presentation.
The median time to onset of CRS was 4 days, compared with 2 days in the ZUMA-1 trial. “This may have implications for the possibility of outpatient therapy,” she said.
A study is planned to look at outpatient administration of axi-cel in patients with indolent NHL, she added.
Dr. Jacobson said she had no conflicts of interest to declare. Coauthors reported disclosures related to Kite, a Gilead Company; Genentech; Epizyme; Verastem; Novartis; and Pfizer, among others.
Correction, 12/7/20: An earlier version of this article misattributed some aspects of the ZUMA-5 trial to ZUMA-1.
SOURCE: Jacobson CA et al. ASH 2020, Abstract 700.
FROM ASH 2020