FDA grants fast track designation to inobrodib for RRMM

On June 13, 2023, the U.S. Food and Drug Administration (FDA) granted fast track designation to inobrodib (CCS1477) for the treatment of patients with relapsed/refractory multiple myeloma (MM) who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.¹ Inobrodib was then granted orphan drug designation for the same indication by the U.S. FDA on June 29, 2023.²

Inobrodib is a first-in-class oral selective small molecule inhibitor of the p300 and the CREB-binding protein (CBP) bromodomain. By inhibiting the bromodomain on these twin proteins, the expression of key cancer drivers, including MYC, interferon regulatory factor 4, and the androgen receptor, is limited.³

Clinical development⁴

Inobrodib is currently being investigated as part of an ongoing phase I/IIa trial (NCT04068597) to evaluate its safety and tolerability in patients with MM, non-Hodgkin lymphoma, acute myeloid leukemia, and high-risk myelodysplastic syndromes. Inobrodib is being evaluated in MM as a monotherapy and in combination with pomalidomide and dexamethasone.

Key eligibility criteria

• 18 years or older
• ECOG performance status 0–2
• Relapsed/refractory disease status
• Previous treatment with standard therapy
• Adequate organ function

Endpoints

Primary endpoints:

• Incidence of treatment-related adverse events (within 12 months)
• Incidence of laboratory abnormalities (within 12 months)

Secondary endpoints:

• Response rate
• Duration of response
• Pharmacokinetic metrics of inobrodib