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**What happened**
Bristol Myers Squibb presented the first full Phase 3 results for ZENBEXUS (iberdomide) on September 25, 2026, from the EXCALIBER-RRMM trial in relapsed or refractory multiple myeloma, with results published the same day in The Lancet Oncology. Iberdomide combined with daratumumab and dexamethasone (ZDd) went head-to-head against daratumumab, bortezomib, and dexamethasone (DVd) — and ZENBEXUS became the **first therapy in multiple myeloma to show superiority on an MRD-negative complete response primary endpoint**.
Zenbexus is a CELMoD — the next-generation cousin of lenalidomide and pomalidomide — designed to work through targeted protein degradation, and this is the new drug class’s first full approval-stage readout.
**Why it matters**
Two things make this a serious data point for investors. First, depth of response: adding oral iberdomide to the triplet roughly **doubled the rate of MRD-negative complete responses** across subgroups versus the standard DVd triplet — MRD-negativity is the benchmark that increasingly predicts how long patients stay in remission.
– **Trial:** Phase 3 EXCALIBER-RRMM (iberdomide + daratumumab + dexamethasone vs. daratumumab + bortezomib + dexamethasone)
– **Deepest response:** MRD-negative complete response roughly doubled with ZDd — first superiority win on this endpoint in myeloma
– **Neuropathy (any grade):** 12.3% vs. 42.6% — markedly lower with the iberdomide triplet
– **Grade 3/4 neutropenia:** 84.3% vs. 11.3% — the main trade-off, mostly in the first two cycles, managed with G-CSF support
– **Grade 3/4 infections:** 39.2% vs. 21.6%; fatal infections stayed low at 2.0% vs. 1.5%Second, the regulatory path: Zenbexus already received FDA accelerated approval on August 13, 2026, and these results are the foundation for full approval. The dual primary endpoint of progression-free survival in an 800-patient confirmatory cohort is still being evaluated — that readout is the real catalyst left.
**What to watch**
Watch for the confirmatory progression-free survival readout — full approval hinges on it. Also track how quickly community oncology practices adopt an oral triplet, since ease of administration was a highlighted advantage. And keep an eye on pricing and payer positioning against existing relapsed-myeloma options.
Related reading: [FDA Approves Elevar’s Lyrfigtu for FGFR2 Bile Duct Cancer](https://bullounge.com/forums/topic/fda-approves-elevars-lyrfigtu-for-fgfr2-bile-duct-cancer/) and [Genentech Signs $1.5B Deal With Earendil for AI-Designed Cancer Antibodies](https://bullounge.com/forums/topic/genentech-signs-1-5b-deal-with-earendil-for-ai-designed-cancer-antibodies/)
Does a cleaner neuropathy profile and an oral triplet make Zenbexus a serious challenger in relapsed myeloma — or does the 84% Grade 3/4 neutropenia rate keep it a niche option?
Sources:
– https://www.businesswire.com/news/home/20260924614211/en/Bristol-Myers-Squibb-Announces-First-Presentation-of-Results-for-ZENBEXUS-iberdomide-in-Combination-with-Daratumumab-from-Phase-3-EXCALIBER-RRMM-Trial-in-Relapsed-or-Refractory-Multiple-Myeloma
– https://www.morningstar.com/news/business-wire/20260924614211/bristol-myers-squibb-announces-first-presentation-of-results-for-zenbexus-iberdomide-in-combination-with-daratumumab-from-phase-3-excaliber-rrmm-trial-in-relapsed-or-refractory-multiple-myeloma
– https://pharmacally.com/zenbexus-iberdomide-multiple-myeloma-excaliber-rrmm/Auto-posted by the Bull Lounge news desk.
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