Data from the Phase I/II TRANSCEND CLL 004 study evaluating the combination of Bristol Myers Squibb’s (BMS’s) Breyanzi (lisocabtagene maraleucel) with Johnson & Johnson’s (J&J’s) Imbruvica (ibrutinib) for relapsed/refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) were presented at the American Society of Hematology (ASH) annual meeting held from 7 December to 10 December 2024 in San Diego, California.

The study protocol requires patients to take ibrutinib for varying lengths of time before undergoing leukapheresis. They may continue to take ibrutinib after chimeric antigen receptor (CAR) T cell infusion. At the January 2024 data cutoff, 50% of enrolled patients had completed or were currently participating in the study. The objective response rate was 86%, with a median duration of response of 41.4 months. A total of 45% of the patients achieved complete remission.

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Secondary endpoints included a median progression-free survival of 31.4 months, but no median overall survival was reached. The regimen was well tolerated, with 86% of patients experiencing a grade ≥3 treatment-related adverse event (TRAE). There were no grade 5 cases, and cytopenia was the most common TRAE.

$2.6 billion sales of Breyanzi are predicted by 2030

Breyanzi was granted accelerated approval in early 2024 to treat CLL/SLL based on data from a separate cohort of TRANSCEND CLL 004, in which 20% of patients achieved a complete response (CR). Breyanzi is the first CAR T cell therapy approved for CLL, and it is recommended for patients who have progressed on Bruton’s tyrosine kinase (BTK) and BCL2 inhibitors. Patients who fail both drug classes represent the greatest unmet need in CLL, so the 20% CR rate is significant. To improve CAR T cell efficacy, ibrutinib targets CAR T cell-hindering myeloid-derived suppressor cells that express BTK and are common in CLL. No other CAR T cell therapy is currently approved when combined with a BTK inhibitor.

BMS is also evaluating Breyanzi in combination with AbbVie‘s BCL2 inhibitor Venclexta (venetoclax). Although the combination results in a significant increase in CR when compared to CAR T cell therapy alone, questions remain about the optimal amount of BTK exposure required before T cell collection and the appropriate BTK inhibitor to generate the most potent CAR T cell therapy. The trial sponsors chose ibrutinib, a first-generation BTK inhibitor, over AstraZeneca‘s Calquence (acalabrutinib) or Eli Lilly’s recently approved Jaypirca (pirtobrutinib). Breyanzi generated $364 million in sales in 2023 and is projected to reach $2.6 billion by 2030, according to GlobalData’s analyst consensus forecast.

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