• The outcome of the Phase 1 ZUMA-3 study was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
   
• The results would be facilitating guidance on KTE-X19 safety & dosing management to help the ongoing Phase 2 study.

Kite, a Gilead Company (Kite) and a renowned firm developing innovative methods of treating cancer, has reportedly announced the results of a Phase 1 ZUMA-3 clinical study that evaluates a novel Chimeric Antigen Receptor T (CAR T) cancer therapy, KTE-X19 in treating refractory or relapsed Acute Lymphoblastic Leukemia (ALL).

Reports cite, the outcome of the ZUMA-3 study was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois under abstract number 7006. The results would be facilitating guidance on KTE-X19 safety & dosing management to help the ongoing Phase 2 study.

According to a press release by Kite, approximately 45 patients participated in the Phase 1 study and received one of three predetermined KTE-X19 doses. Of the 45 patients, 41 were evaluable after a minimum period of two months, 68% of this demographic attained Complete Response (CR) with incomplete Hematological Recovery (CRi). Moreover 100% of responders showed undetectable Minimal Residual Disease (MRD).

The study identified no dose limiting toxicities (DLTs). Additionally, Grade ≥3 neurologic events & cytokine release syndrome (CRS) occurred in over 38% and 29% of people, respectively. While, two patients developed grade-5 adverse events, a revised AE-management protocol was implemented to mitigate the problem.

ZUMA-3 investigator & medical oncologist at Moffitt Cancer Center, Bijal Shah, MD stated that adults suffering from refractory or relapsed ALL represent a patient population that is significantly difficult to treat. Dr. Shah further added that the center was encouraged by the study’s high response rates along with the reduced severity & incidence of neurologic events & CRS, which were observed after the revised safety-management protocol implementation.

According to reports, the firm is now evaluating KTE-X19 at a selected dose that follows the safety management protocol under the ongoing ZUMA-3 Phase 2 clinical study.

Source Credit:

https://www.apnews.com/Business%20Wire/89eaab7f7a6f4395954fa90c49528e12

https://www.businesswire.com/news/home/20190601005017/en/