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Bristol gets another celmod victory

Bristol Myers Squibb, positioning its celmods as potential follow-ons to Revlimid and Pomalyst, has notched up another win, this time with mezigdomide. The company said on Monday that the Successor-2 trial, in relapsed/refractory multiple myeloma, had met its primary endpoint of progression-free survival. The study tests mezigdomide plus Kyprolis and dexamethasone versus Kyprolis/dexamethasone alone. Data will be presented at an upcoming medical meeting; for now, overall survival, a secondary endpoint, is immature. Meanwhile, readout from another mezigdomide trial, Successor-1, was recently delayed from 2026 to 2027. That’s also in relapsed multiple myeloma, but evaluates a different combo: mezigdomide plus Velcade and dexamethasone. The latest win comes after Bristol toplined success last year with another celmod, iberdomide; this project is now awaiting an FDA decision by August in relapsed multiple myeloma, based on minimal residual disease (MRD) negativity, an endpoint that’s gaining momentum with regulators. Data on a more conventional endpoint, progression-free survival, are expected this year. Bristol’s final late-stage celmod, golcadomide, is being tested in lymphomas and is further behind, with data from its pivotal programme not due until 2028.

 

Bristol’s pivotal-stage cereblon E3 ligase modulators (celmods)

ProjectSubstrateTrialSettingRegimenTiming
Mezigdomide (CC-92480/ BMS-986348)Aiolos & IkarosSuccessor-1R/r multiple myeloma (1-3 prior lines)+ Velcade + dexamethasone, vs Pomalyst + Velcade + dexamethasoneData due 2027 (previously 2026)
Successor-22nd-line multiple myeloma+ Kyprolis + dexamethasone, vs Kyprolis + dexamethasoneToplined positive for PFS Mar 2026
Iberdomide (CC-220)Aiolos & IkarosExcaliber-RRMM2nd-line multiple myeloma+ Darzalex + dexamethasone, vs Darzalex + Velcade + dexamethasoneToplined positive for MRD negativity rates Sep 2025; PDUFA date 17 Aug 2026; PFS data due 2026*
Excaliber-Maintenance1st-line multiple myeloma maintenanceVs Revlimid maintenance following ASCTData due 2029
Golcadomide (CC-99282/ BMS-986369)Aiolos & IkarosGolseek-11st-line LBCL+ Rituxan + chemo, vs Rituxan + chemoData due 2028
Golseek-42nd-line follicular lymphoma+ Rituxan, vs Ritxuan + Revlimid or chemoData due 2028

Note: *MRD-negativity & PFS are co-primary endpoints. Source: OncologyPipeline.

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