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)
| Project | Substrate | Trial | Setting | Regimen | Timing |
|---|---|---|---|---|---|
| Mezigdomide (CC-92480/ BMS-986348) | Aiolos & Ikaros | Successor-1 | R/r multiple myeloma (1-3 prior lines) | + Velcade + dexamethasone, vs Pomalyst + Velcade + dexamethasone | Data due 2027 (previously 2026) |
| Successor-2 | 2nd-line multiple myeloma | + Kyprolis + dexamethasone, vs Kyprolis + dexamethasone | Toplined positive for PFS Mar 2026 | ||
| Iberdomide (CC-220) | Aiolos & Ikaros | Excaliber-RRMM | 2nd-line multiple myeloma | + Darzalex + dexamethasone, vs Darzalex + Velcade + dexamethasone | Toplined positive for MRD negativity rates Sep 2025; PDUFA date 17 Aug 2026; PFS data due 2026* |
| Excaliber-Maintenance | 1st-line multiple myeloma maintenance | Vs Revlimid maintenance following ASCT | Data due 2029 | ||
| Golcadomide (CC-99282/ BMS-986369) | Aiolos & Ikaros | Golseek-1 | 1st-line LBCL | + Rituxan + chemo, vs Rituxan + chemo | Data due 2028 |
| Golseek-4 | 2nd-line follicular lymphoma | + Rituxan, vs Ritxuan + Revlimid or chemo | Data due 2028 |
Note: *MRD-negativity & PFS are co-primary endpoints. Source: OncologyPipeline.
41