Bristol Myers Squibb (BMS) has announced that it has received FDA approval for its oral CELMoD therapy, Zenbexus, in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).
The combination treats patients with multiple myeloma who have already received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. It will be available to patients from first relapse onward.
Approval comes after positive results from the phase 3 EXCALIBER-RRMM trial in relapse or refractory multiple myeloma (RRMM). ZDb resulted in minimal residual disease (MRD)-negative complete response (CR) rates of 41% at 16 months compared to MDR-negative CR rates of 21% with daratumumab, bortezomib, and dexamethasone.
Zenbexus is the first CELMoD to receive FDA approval. However, BMS has another oral CELMoD candidate in its pipeline: mezigdomide with carfilzomib and dexamethasone. In a phase 3 trial comparing the combination to carfilzomib and dexamethasone alone in patients with RRMM, the therapy led to a clinically-meaningful and statistically-significant improvement in progression-free survival of 18 months vs. 8.3 months.