Kite’s TECARTUS (Brexucabtagene Autoelucel) Demonstrates Sustained Overall Survival in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia
June 3, 2024 – Biotechnology, Clinical Trials, Pharmaceutical – Gilead Sciences, Kite Pharma, clinical trials, oncology
- After more than four years of follow-up in the pivotal ZUMA-3 study, median overall survival was 26 months and four-year overall survival rate was 40% at 48 months
- Survival benefit was seen regardless of age, prior treatment or subsequent allogeneic stem cell transplant status
- Data being presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
3 June 2024 — Stockley Park, UK — Kite, a Gilead Company, today announced updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia (R/R B-ALL). The findings showed a median OS of 25.6 months and a four-year OS rate of 40% (95% CI, 28-52) in all treated patients with a safety profile consistent with that observed in the three-year analysis. The results were presented today in a poster presentation (Abstract #6531) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
“B-ALL is a rare and aggressive form of blood cancer associated with poor prognosis – with a median survival rate of less than eight months in those with relapsed or refractory disease – so to see 40% of these patients treated with one infusion of brexu-cel still alive after four years is quite meaningful indeed,” said Olalekan O Oluwole MBBS MD MPH, associate professor of Medicine, Haematology/Oncology at Vanderbilt University and primary investigator for the study. “Additionally, the duration of response and survival benefits were demonstrated regardless of the patients’ subsequent allogeneic stem cell transplant status.”
In the poster being presented, patients treated with the pivotal dose of brexucabtagene autoleucel in the pooled analysis phase 1 and 2 (n=78), the median follow-up time was 53.6 months (range 44.7-82.3) with 4-year minimum follow-up. Among all treated patients, the median OS was 25.6 months, and 47 months in patients with complete remission or complete remission with incomplete haematologic recovery (n=57), the primary endpoint. In patients <26 years (n=15), median OS (95% CI) was 23.2 months (9.0-NE) and was 26.0 months (15.9-NE) in patients ≥26 years (n=63), OS was a key secondary endpoint. Median OS (95% CI) in patients with one prior therapy (n=15) was 60.4 months (7.6-NE) and was 25.4 months (15.9-47.0) in patients with ≥2 prior therapies (n=63).1
Medians for OS (95% CI) in patients with (n=38) and without (n=40) prior blinatumomab were 15.9 (8.3-26.0) and 60.4 months (18.6-NE), respectively (unbalanced patient characteristics and small numbers limit interpretation of these results). Median OS (95% CI) was 36.3 months (10.2-NE) in responders who went on to subsequent allogeneic stem cell transplant (n=14) and 60.4 months (23.2-NE) in those who did not (n=43). No new adverse events or deaths occurred since the three-year analysis. Rates of infection were Grade ≥3 and higher in patients over 26 years and in patients with prior blinatumomab.
“We are pleased that brexucabtagene autoleucel continues to demonstrate improved survival outcomes after four years of follow-up in adult patients who would otherwise have very few treatment options,” said Ibrahim Elhoussieny MD, vice president, Medical Affairs, Kite. “Notably, brexucabtagene autoleucel numerically improved overall survival particularly for patients when given in earlier lines of therapy, and is an important treatment option for the large portion of adult B-ALL patients who relapse or are refractory to other treatments. We look forward to continuing to improve survival in more people with this challenging blood cancer.”
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, US, 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. Visit: www.kitepharma.com.
About Gilead Sciences
Gilead Sciences 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, US. Gilead acquired Kite in 2017. Visit: www.gilead.com.
