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Bristol touts a marginal zone win

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 BeiGene’s BTK inhibitor Brukinsa has accelerated approval, while Abbvie/Johnson & Johnson’s Imbruvica was withdrawn after failing to show a survival benefit in its confirmatory study.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

DrugMechanismCompanyStatus in MZLTrialNORRCR rate
ImbruvicaBTK inhibitorAbbVie/J&J2017 AA for post-CD20 use; rescinded 2023PCYC-11216346%3%
BrukinsaBTK inhibitorBeiGene2021 AA for post-CD20 useMagnolia6656%20%
NCT023431202080%20%
ZynlontaAnti-CD19 ADCADC TherapeuticsNot approvedNCT05296070*2391%70%
BreyanziAnti-CD19 Car-TBristol Myers SquibbNot approvedTranscend FL???

Note: *investigator-sponsored. Source: OncologyPipeline.

This story has been updated with comments from Bristol Myers Squibb.

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Molecular Drug Targets