On January 26, Bristol Myers Squibb (BMS) announced positive results from the pivotal Phase I/II TRANSCEND CLL 004 clinical trial evaluating its chimeric antigen receptor (CAR) T-cell therapy Breyanzi (lisocabtagene maraleucel) in adults with relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) who were refractory to a Bruton’s tyrosine kinase (BTK) inhibitor and pre-treated with a BCL-2 inhibitor. These results indicate that the trial met the primary endpoint of complete response rate and provides hope to patients in this underserved subpopulation.

CLL is a haematological cancer that originates from lymphocytes in the bone marrow and later invades the blood and/or lymphoid tissues. It is the most common form of leukaemia in adults, with an estimated 18,740 new cases of CLL in 2023 in the US. While patients with R/R CLL can be treated with agents such as BTK and BCL-2 inhibitors, those who progress on these drugs have a high unmet need as there is no standard of care for these patients after prior therapy with targeted agents. Therefore, developing therapies with novel mechanisms of action for this patient subpopulation remains a key unmet need. Breyanzi is a CD19-directed CAR T-cell therapy approved by the US Food and Drug Administration (FDA) for use in later-line settings for other haematological cancers, including diffuse large B-cell lymphoma and follicular lymphoma.

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TRANSCEND CLL 004 is the first multi-centre trial to investigate a CAR T-cell therapy in heavily pre-treated patients with R/R CLL. Anne Kerber, senior vice-president and head of Cell Therapy Development at BMS, states that: “CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging.” Previously, Phase I results from this trial showed that 22 patients with R/R CLL who developed resistance to BTK inhibitors exhibited an overall response of 82% and a complete response of 45%. In the Phase II portion of the trial, no new safety signals for Breyanzi were outlined, and the company aims to present this efficacy data at an upcoming medical meeting. BMS is confident that Breyanzi monotherapy can be a one-time administered therapy for these difficult-to-treat patients.

According to GlobalData’s recently published ‘CLL: Cell Therapies 15-Market Assessment and Sales Forecast’ report, Breyanzi’s CLL sales in the US are expected to reach $230m by 2031, while Autolous Therapeutics’s CAR-T cell therapy AUTO1 is anticipated to reach sales of $253m in the US by 2031. Despite Breyanzi being forecast to gain the first-to-market advantage, GlobalData expects Breyanzi’s high instances of neurological toxicity to sway patients toward AUTO1. Nevertheless, BMS is expected to pursue label expansions for Breyanzi in multiple haematological cancers, including in earlier-line settings.