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Bristol touts a marginal zone win
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Bristol Myers Squibb’s CD19-targeting Car-T Breyanzi, already approved in follicular lymphoma, might be heading towards use in another relatively indolent blood cancer, marginal zone lymphoma (MZL). On Monday the company said the MZL cohort of the Transcend FL trial had read out positively; Bristol didn’t disclose any data, but noted a “statistically significant and clinically meaningful” overall response rate, the primary endpoint of the uncontrolled trial. A Bristol spokesperson told ApexOnco that the company would discuss the data with regulators, but declined to speculate on timings. MZL is relatively indolent and accounts for around 7% of non-Hodgkin lymphoma cases. BeiGene’s BTK inhibitor Brukinsa has accelerated approval, while Abbvie/Johnson & Johnson’s Imbruvica was withdrawn after failing to show a survival benefit in its confirmatory study. The project to beat, however, might be ADC Therapeutics’ Zynlonta, which has produced an ORR of 91%. Still that study, as well as being small and investigator-sponsored, enrolled second-line or later patients, while Transcend FL included MZL patients who had received two or more prior therapy lines. Given MZL’s slow-growing nature, Breyanzi’s side-effect profile will also be watched; the therapy, which sold $591m in 2024, has warnings of serious infection, cytopenias and secondary malignancies.
Cross-trial comparison in marginal zone lymphoma
Drug | Mechanism | Company | Status in MZL | Trial | N | ORR | CR rate |
---|---|---|---|---|---|---|---|
Imbruvica | BTK inhibitor | AbbVie/J&J | 2017 AA for post-CD20 use; rescinded 2023 | PCYC-1121 | 63 | 46% | 3% |
Brukinsa | BTK inhibitor | BeiGene | 2021 AA for post-CD20 use | Magnolia | 66 | 56% | 20% |
NCT02343120 | 20 | 80% | 20% | ||||
Zynlonta | Anti-CD19 ADC | ADC Therapeutics | Not approved | NCT05296070* | 23 | 91% | 70% |
Breyanzi | Anti-CD19 Car-T | Bristol Myers Squibb | Not approved | Transcend FL | ? | ? | ? |
Note: *investigator-sponsored. Source: OncologyPipeline.
This story has been updated with comments from Bristol Myers Squibb.
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