— In Three-Year Follow-up in Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia, Tecartus Shows High Rates of Durable Response (CR+CRi 71%) and a Median Overall Survival of 26 Months —

SANTA MONICA, CA, USA I February 09, 2023 I Kite, a Gilead Company (Nasdaq: GILD), today announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel). Results from the analysis showed a median overall survival (OS) of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) with a consistent safety profile observed since the two-year analysis. These findings were presented today during a poster session at the 5th European CAR T-cell Meeting, taking place in Rotterdam, the Netherlands.

“For adult patients living with ALL, there is a need for therapeutic options that provide long-term responses,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. “The continued durable response and significant improvement in survival indicated by these new data can potentially establish a new standard of care for adult patients living with this aggressive form of leukemia.”

In the Phase 2 treated patient cohort (n=55) the median follow-up was 38.8 months (range, 32.7-44.6). The OS rate at 36.0 months was 47.1% (95% CI, 32.7-60.2), with a median OS of 26.0 months among all treated Phase 2 patients (n=55) and 38.9 months in patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi; n=39). Overall CR rate (CR + CRi), CR, and subsequent allogeneic stem cell transplant (alloSCT) rates remained unchanged since the prior data cut at 71%, 56%, and 20%, respectively. Median (95% CI) relapse-free survival (RFS) censored and not censored at subsequent alloSCT were both 11.6 (2.7-20.5) and 11.7 months (2.8-20.5), respectively.

For patients treated at the pivotal dose in both Phase 1 and 2 (n=78), the median follow-up at data cutoff was 41.6 months (range, 32.7-70.3). Median (95% CI) DOR censored and not censored at subsequent alloSCT was 18.6 (9.6-24.1) and 20.0 (10.3-24.1) months, respectively. Median (95% CI) RFS were both 11.7 (6.1-20.5) months. At data cutoff, 36% of patients (28) were still alive with a median OS of 25.6 months (95% CI, 16.2-47.0) in all treated patients (n=78). The proportion of pooled Phase 1 and 2 patients with Grade ≥3 AEs that were deemed treatment-related was unchanged since the prior data cut. No Grade 5 AEs occurred since the prior data cut off.

“We are encouraged by the sustained benefit that a single one-time treatment of Tecartus continues to provide for patients living with this difficult-to-treat blood cancer,” said Frank Neumann, MD, PhD, SVP, Kite’s Global Head of Clinical Development. “Our hope is that these results, along with our commitment to long-term research of Tecartus, will continue to provide clarity to physicians on optimal treatment methods for these patients living with this rare disease who have suffered historically poor outcomes.”

In this trial, longer follow-up of the pivotal analysis and outcomes of a larger pooled analysis of Phase 1 and 2 patients who received the pivotal dose of Tecartus were reported. Most patients in the analysis were heavily pre-treated, with a median of two prior therapies, and 47% had received three or more prior therapies.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, Europe), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and alloSCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive and rare type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. While 80% of ALL occurs in children, it represents a devastating disease in adults. In adults, B-cell precursor ALL is the most common form, accounting for 75% of cases. Survival rates in adults with R/R B-ALL are poor, with median OS at less than eight months.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

  • Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences acquired Kite in 2017.

SOURCE: Gilead Sciences