Encouraging New Data Presented on Kite’s YESCARTA (Axicabtagene Ciloleucel) for Relapsed/Refractory Central Nervous System Lymphoma
June 3, 2024 – Biotechnology, Clinical Trials, Pharmaceutical – ASCO 2024, Gilead Sciences, Kite Pharma, R/R CNSL, oncology
- At median follow-up of 24.2 months, no apparent additional risks of adverse events related to axicabtagene ciloleucel were seen
- Findings also suggest efficacy trend with median progression-free survival and durability of response of more than 12 months
- Data presented orally at the 2024 American Society Of Clinical Oncology (ASCO) Annual Meeting.
3 June 2024 — Stockley Park, UK — Kite, a Gilead Company, announced data from a pilot study in collaboration with Dana-Farber Cancer Institute, that demonstrate Yescarta (axicabtagene ciloleucel) is well-tolerated in patients living with relapsed or refractory (R/R) primary or secondary central nervous system lymphoma (PCNSL and SCNSL). The findings, which also showed efficacy benefits, were presented today in an oral session (Abstract #2006) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Central nervous system lymphoma (CNSL) is an aggressive and rare form of non-Hodgkin lymphoma that has either originated in (primary) or spread to (secondary) the brain, eye, spinal cord or cerebrospinal fluid. The prognosis of PCNSL has historically been poor with a five-year survival rate of only 30%. More than half of the patients experience a relapse after front-line treatment, with a median survival of approximately two months. R/R CNSL is considered an area of unmet clinical need with no standard of care treatment options.
“Patients with central nervous system involvement of large B-cell lymphoma were excluded from the studies that led to the FDA approval of axi-cel in relapsed/refractory large B-cell lymphoma,” said Lakshmi Nayak MD, associate professor of Neurology, Harvard Medical School and Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute. “We conducted this pilot study to evaluate the safety of axi-cel in CNSL patients and to see if there would be a preliminary signal of efficacy. Not only did we see a high response rate with axi-cel in this heavily pre-treated population, but they were durable. While we need more data to evaluate axi-cel in a larger study, these results are promising and represent a significant breakthrough in the treatment of this particularly rare and aggressive brain cancer for which there are limited options when it recurs.”
In this pilot study of 18 patients with CNSL, at a median follow-up of 24.2 months, no treatment-limiting toxicities and no apparent additional risk of adverse events were reported. Immune effector cell-associated neurologic syndrome (ICANS) were observed among 44% of patients (27.8% were Grade >3).
The objective response rate was 94.4% and the complete response rate was 66.7%. The median time to best response was three months. The median duration of response was 13.4 months and 9 patients had progressed. At a median follow-up of 24 months, the median progression-free survival was 14.3 months (95% CI: 6.3-NR) and median overall survival was 26.4 months (95% CI: 11.2-NR).
90% of patients developed grade 1 or 2 cytokine release syndrome; two patients developed Ommaya-related meningitis requiring explant with subsequent recovery. One patient developed grade 3 electrographic focal status epilepticus that resolved with anti-epileptic agents. Seven patients have died, all from disease progression.
“We are very encouraged by the data presented today indicates the potential to extend the benefits of axicabtagene ciloleucel to people with both primary and secondary CNSL, whose prognoses are typically very poor,” said Ibrahim Elhoussieny MD, vice president, Medical Affairs, Kite. “This early data supports that CAR T-cell therapy may potentially offer a treatment option to these patients.”
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.
