New Data From ZUMA Trials Offer Greater Understanding of CAR T-cell Therapies

Attendees during the day at the American Society of Clinical Oncology (ASCO) Courtesy: ? ASCO/Scott Morgan.
Attendees during the day at the American Society of Clinical Oncology (ASCO) Courtesy: ? ASCO/Scott Morgan.

New, updated data from cell therapy programs including axicabtagene ciloleucel (Yescarta?; Kite Pharma) and KTE-X19, an investigational company?s chimeric antigen receptor T (CAR T-) cell therapy, will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, Ill. from May 31 ? June 4, 2019.

Axicabtagene ciloleucel was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

A total of six abstracts will highlighting updated data from axicabtagene ciloleucel, including efficacy and safety results, and ongoing research from Kite Pharma’s CAR T-cell therapy development program in hematologic malignancies will be presented at the meeting.

?Our CAR T research program is progressing at a rapid pace and we are excited to share the latest data at ASCO,? said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences, the parent company of Kite Pharma.

?Our data at this year?s meeting will include new analyses from the pivotal ZUMA-1 trial of [axicabtagene ciloleucel], early results from a novel approach to improve the [axicabtagene ciloleucel] safety profile and results from the ZUMA-3 trial of our investigational CAR T therapy KTE-X19 in adults with acute lymphoblastic leukemia. These findings will help physicians better assess the potential role of CAR T in patients with high unmet need and continue to build upon our understanding of cell therapy,? McHutchison added.

Overview of Presentations

Data from Kite Pharma’s ZUMA CAR T cell therapy development program to be presented during the 2019 ASCO meeting include new results evaluating earlier steroid use on the rates of adverse events in patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel, as well as a separate sub-population analysis of efficacy and safety results in refractory large B-cell lymphoma patients over the age of 65 in the ZUMA-1 trial. And end of Phase I data from the ZUMA-3 trial of investigational KTE-X19 in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) will also be presented.

CAR T-Cell / ZUMA Presentations
TitleAbstractDate/Time
End of Phase 1 Results of ZUMA-3, a Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (Oral Presentation)|Location: E451| (Acute Lymphoblastic Leukemia) | J Clin Oncol 37, 2019 (suppl; abstr 7006)7006Saturday
June 1
(5:00-5:12 pm)
Outcomes of Patients ? 65 Years of Age in ZUMA-1, a Pivotal Phase 1/2 Study of Axicabtagene Ciloleucel in Refractory Large B-Cell Lymphoma (Poster presentation)| Location: Hall A | Board #309 | (Large B-Cell Lymphoma) | J Clin Oncol 37, 2019 (suppl; abstr 7555)7555Monday
June 3 (8:00-11:00 am)
Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma (Poster Presentation | Location: Hall A | Board #312)(Large B-Cell Lymphoma) | J Clin Oncol 37, 2019 (suppl; abstr 7558)7558Monday
June 3 (8:00-11:00 am)
Hematopoietic Recovery and Immune Reconstitution After Axicabtagene Ciloleucel Chimeric Antigen Receptor T Cell Therapy in Patients with Relapsed/Refractory Large B-cell Lymphoma (Poster Presentation | Location: Hall A | Board #299)(Large B-Cell Lymphoma) | J Clin Oncol 37, 2019 (suppl; abstr 7545)7545Monday
June 3 (8:00-11:00 am)
ZUMA-8: A Phase 1/2 Multicenter Study Evaluating KTE-X19 in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (Poster Presentation | Location: Hall A | Board #320a)(Chronic Lymphocytic Leukemia) | J Clin Oncol 37, 2019 (suppl; abstr TPS7566)TPS7566 Monday
June 3 (8:00-11:00 am)
ZUMA-12: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel as a First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma (Poster Presentation | Location: Hall A | Board #324a )(Large B-Cell Lymphoma) | J Clin Oncol 37, 2019 (suppl; abstr TPS7574)TPS7574 Monday
June 3 (8:00-11:00 am)