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ASH 2023 | Brexu-cel in the treatment of R/R MCL: insights from the ZUMA-2 and ZUMA-18 trials

Max Topp, MD, University Hospital Wurzburg, Wurzburg, Germany, discusses the efficacy of brexucabtagene autoleucel (brexu-cel), an anti-CD19 CAR-T product, in relapsed/refractory (R/R) mantle cell lymphoma (MCL), which has been evaluated in the ZUMA-18 (NCT04162756) and ZUMA-2 (NCT02601313) trials. The findings indicate a high overall response rate (ORR), which is durable over 47.5 months, with manageable toxicity profiles. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (edited for clarity)

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.

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Disclosures

Regeneron Pharmaceuticals, Inc.: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Travel support, Research Funding; AstraZeneca: Consultancy, Research Funding; AbbVie: Consultancy; Bristol Myers Squibb: Consultancy, Research Funding; GenMab: Consultancy; Takeda: Research Funding; Janssen: Consultancy, Travel support; Roche: Consultancy, Research Funding.