So ZUMA-18 was an early access program after the ZUMA-2 data was available, for patients with mantle cell lymphoma having access to tecartus (brexu-cel). Overall, another 22 patients were recruited in ZUMA-18 and then combined together with ZUMA-2 to get a more in-depth look at the patient’s characteristics, response, and toxicity, in the situation. So altogether, the patients that were recruited in the ZUMA-18 are very similar in terms of demographic features, like previously recruited in ZUMA-2...
So ZUMA-18 was an early access program after the ZUMA-2 data was available, for patients with mantle cell lymphoma having access to tecartus (brexu-cel). Overall, another 22 patients were recruited in ZUMA-18 and then combined together with ZUMA-2 to get a more in-depth look at the patient’s characteristics, response, and toxicity, in the situation. So altogether, the patients that were recruited in the ZUMA-18 are very similar in terms of demographic features, like previously recruited in ZUMA-2. The objective response rates that were achieved in ZUMA-18 in the early access program were very similar to the ZUMA-2, with 75% of the patients having a response in the situation, which is durable in the responding patients over a period of more than 47.5 months.
The toxicity profile also in the early access program was very similar with only a very small fraction of patients, less than 10%, getting grade-three or four cytokine release syndromes. Neurotoxicity was seen in about a third of the patients. But these two major toxicities, which you would see with CAR T-cell therapy, were resolved within days under the intervention of steroids and/or tocilizumab. So overall ZUMA-2 and ZUMA-18 proves that brexu-cel is a very valuable approach for patients with relapsed/refractory mantle cell lymphoma.