news/GILD/2023.02.10/Kite's tecartus car t-cell therapy demonstrates overall survival benefit in three-year ...txt

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-3ZUMA-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 LeukemiaALL 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 KiteKite, 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.About Gilead SciencesGilead 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.Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead and Kite's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Tecartus; the risk that physicians and patients may not see the potential benefits of Tecartus for the treatment of adult patients with relapsed or refractory B-cell ALL and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.Contact:Email: [email protected](C) 2023 Electronic News Publishing, source ENP Newswire