Breyanzi Shows Significant Results in B-Cell Malignancies at 2024 ASCO Meeting

Bristol Myers Squibb has announced promising data from three key studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel). This includes long-term follow-up data from the Phase 3 TRANSFORM trial for large B-cell lymphoma (LBCL) patients, as well as subgroup analyses from the TRANSCEND NHL 001 and TRANSCEND FL trials. The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting Breyanzi's transformative potential across a range of B-cell malignancies.

Long-Term Results from TRANSFORM Trial

The Phase 3 TRANSFORM trial evaluated Breyanzi as a second-line therapy in patients with relapsed or refractory LBCL. Involving 184 patients randomized to receive either Breyanzi or the standard of care (salvage chemotherapy followed by high-dose chemotherapy and autologous hematopoietic stem cell transplant), the trial demonstrated significant clinical benefits for Breyanzi over a median follow-up of 33.9 months.

Key outcomes showed that Breyanzi markedly improved event-free survival (EFS) with a median of 29.5 months compared to 2.4 months for the standard of care. The 36-month EFS rate was 45.8% for Breyanzi versus 19.1% for standard therapy. Additionally, Breyanzi achieved a higher overall response rate (87%) and a complete response rate (74%) in comparison to the standard regimen. Other efficacy endpoints like progression-free survival (PFS) and duration of response (DOR) also favored Breyanzi.

Lead investigator, Dr. Manali Kamdar, emphasized the importance of these sustained benefits, noting the advantage of incorporating CAR T cell therapy earlier in treatment for LBCL patients.

Subgroup Analyses from TRANSCEND Trials

TRANSCEND NHL 001

The TRANSCEND NHL 001 study focused on adults with relapsed or refractory mantle cell lymphoma (MCL) who had undergone at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. The analysis showed Breyanzi's consistent efficacy across various subgroups. Patients with 2-4 prior lines of therapy showed the greatest benefit, although those with more than five prior treatments exhibited shorter DOR. Overall, Breyanzi maintained a favorable safety profile with low incidences of severe cytokine release syndrome (CRS) and neurologic events (NE).

TRANSCEND FL

This study assessed Breyanzi in relapsed or refractory follicular lymphoma (FL), evaluating the impact of bridging therapy. Results indicated high overall response rates (ORR) regardless of bridging therapy status, with complete response rates remaining high in both subgroups. Median DOR, PFS, and overall survival (OS) were not reached, indicating durable responses. Safety data were consistent across both groups.

Regulatory Milestones

Breyanzi has recently received accelerated FDA approval for adults with relapsed or refractory FL after two or more lines of therapy. Similarly, it gained approval for relapsed or refractory MCL patients who had at least two prior lines of therapy, including a BTK inhibitor. These approvals extend Breyanzi's use to several types of B-cell lymphomas.

Conclusion

The data presented at ASCO 2024 underscore Breyanzi's role as a transformative CAR T cell therapy. Bristol Myers Squibb remains committed to advancing innovative treatments to improve patient outcomes across a variety of B-cell malignancies. The recent studies demonstrate Breyanzi's potential as a high-impact therapy, particularly for patients with relapsed or refractory conditions, offering sustained clinical benefits and a consistent safety profile.

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