Bristol Myers Squibb Reports First Data From Phase 3 EXCALIBER-RRMM Trial
核心洞察
Bristol Myers Squibb (搜索) reported first Phase 3 EXCALIBER-RRMM results for iberdomide plus daratumumab and dexamethasone in relapsed or refractory multiple myeloma (搜索).
The iberdomide regimen produced a 41% MRD-negative complete response rate versus 21% for daratumumab, bortezomib and dexamethasone in 420 patients.
The FDA granted accelerated approval to ZENBEXUS (搜索) (iberdomide) in August 2026, the first myeloma approval based on MRD-negative complete response data.
Bristol Myers Squibb (搜索) has presented the first results from the Phase 3 EXCALIBER-RRMM trial of iberdomide (ZENBEXUS (搜索)) plus daratumumab and dexamethasone in relapsed or refractory multiple myeloma (搜索). In the primary efficacy analysis of the first 420 randomized patients, the iberdomide-based regimen (IberDd) achieved a 41% MRD-negative complete response rate versus 21% for daratumumab, bortezomib and dexamethasone (DVd), a statistically significant difference (p < 0.0001).
EXCALIBER-RRMM (NCT04975997) is a randomized, multicenter, open-label study that enrolled 939 patients with progressive disease after one to two prior lines of anti-myeloma therapy. Dual primary endpoints are MRD negativity and progression-free survival, with overall survival, overall response rate, duration of response, safety and sustained MRD negativity as additional endpoints. The trial remains ongoing for progression-free survival.
Safety was consistent with the known profiles of the individual agents and the relapsed or refractory myeloma treatment landscape. Neutropenia, anemia, thrombocytopenia, infections, fatigue and gastrointestinal events were most commonly reported, with hematologic toxicities, particularly neutropenia, the most frequent grade 3 or higher events. Iberdomide is a next-generation cereblon (搜索) E3 ligase modulator (CELMoD) designed to enhance anti-myeloma activity through targeted protein degradation and immune activation. In August 2026, the FDA granted accelerated approval to ZENBEXUS (搜索) with daratumumab and dexamethasone for adults with multiple myeloma (搜索) who have received at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent, based on the EXCALIBER-RRMM MRD-negative complete response findings.
Source: OncoDaily