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Breyanzi battles CAR-T rivals with back-to-back approvals in lymphoma

On 15 May 2024, Bristol Myers Squibb (BMS) announced accelerated FDA approval of its agent Breyanzi (lisocabtagene maraleucel) for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more previous lines of systemic therapy, based on the Phase III TRANSCEND FL study. Breyanzi has announced the approval for the treatment of large B-cell lymphoma in the second-line-plus setting, and obtained a first-in-class approval earlier in 2024 for patients with R/R chronic lymphocytic leukaemia or small lymphocytic leukaemia in the third-line-plus setting. The succession of approvals has contributed to a doubling of total global sales from $182 million in 2022 to $364 million in 2023, according to GlobalData’s analyst consensus forecast.

Despite this, Breyanzi’s 2023 sales still lagged behind its chimeric antigen receptor (CAR)-T cell therapy competitors: Gilead and Kite Pharma’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), both of which have received accelerated approval for the same R/R FL setting. However, with this approval and considering other factors, such as treatment response and overall toxicity, Breyanzi emerges as a formidable contender that could potentially take the lead in treating FL.

In the Phase III TRANSCEND FL trial, Breyanzi demonstrated a durable clinical benefit with an overall response rate (ORR) of 95.7% and a complete response (CR) rate of 73.4%, based on a confirmatory negative bone marrow biopsy. Additionally, the median time to response was one month, while the median duration of response was not achieved. In the pivotal trials that led to the approval for Yescarta and Kymriah in the R/R FL setting, the ORR was 91% and 86%, and the CR rate was 74% and 68% respectively. While cross-trial comparisons should be made with caution, Breyanzi exhibits a higher ORR than its counterparts. Furthermore, all three agents display comparable effectiveness in achieving CR, with Kymriah slightly behind.

In terms of side effects associated with CAR-T cell therapies, significant advancements are made in managing cytokine release syndrome (CRS) and neurotoxicity. However, fewer toxicities could influence the choice among CAR-T cell agents. In the pivotal Phase II ZUMA-5 trial, Yescarta showed a higher rate of CRS and neurologic events compared to Kymriah in the pivotal Phase II ELARA trial. Conversely, Breyanzi exhibited fewer side effects, with the most common treatment-related adverse event being any grade CRS in 53% of patients and grade 3 or 4 CRS events in 4% of patients.

Regarding neurotoxicity, neurologic events of any grade occurred in 31% of patients, with grade 3 or 4 events occurring in 10%. However, Breyanzi now carries a boxed warning, indicating the potential risk of developing secondary T-cell malignancies following CD19-directed genetically modified autologous T-cell immunotherapies.

Despite this warning, Breyanzi presents a favourable option for the third-line or later setting in R/R FL due to its overall efficacy and safety. Following positive results of the confirmatory Phase III study currently underway to validate Breyanzi against standard-of-care treatment, GlobalData’s analyst consensus forecast projects the drug’s global sales to reach $2.3 billion and potentially rival Yescarta’s projected global total sales of $2.5 billion by 2030. However, Yescarta may sustain its lead as it pursues expansion into the second-line setting and solidifies its position in R/R FL through the Phase III ZUMA-22 trial.

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