FDA Grants Fast Track Designation to Inobrodib in R/R Multiple Myeloma

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Inobrodib is under investigation as a treatment for patients with relapsed/refractory multiple myeloma and other hematologic malignancies in a phase 1/2a trial.

According to its manufacturers, inobrodib inhibits p300/CBP, thereby affecting the expression of cancer driving genes such as MYC and IRF4 that are central to the progression of hematological malignancies.

According to its manufacturers, inobrodib inhibits p300/CBP, thereby affecting the expression of cancer driving genes such as MYC and IRF4 that are central to the progression of hematological malignancies.

The investigational agent inobrodib (CCS1477) has received fast track designation from the FDA for the treatment of patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, according to a press release from CellCentric.1

Manufacturers have designed the first-in-class inobrodib to be administered orally to patients without the need for intensive monitoring. The drug is intended for use as a supplement to existing standard-of-care agents in the treatment of patients with progressive disease.

Investigators are currently evaluating inobrodib on its own and in combination with other agents including pomalidomide (Pomalyst) and dexamethasone for patients with multiple myeloma in a phase 1/2a clinical trial (NCT04068597). The study also includes patients with other hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia (AML), and high-risk myelodysplastic syndrome (MDS).

“This fast track designation underlines the potential of inobrodib to positively impact the lives of many people living with cancer, who could benefit from the ability to take the treatment at home,” Debbie Haynes, chief operating officer at CellCentric, said in the press release. “This decision allows us to move faster to develop a new therapeutic option that has shown to be effective even when cancer cells have become resistant to other drugs.”

According to its manufacturers, inobrodib inhibits p300/CBP, thereby affecting the expression of cancer driving genes such as MYC and IRF4 that are central to the progression of hematological malignancies.2 Investigators also hypothesize that inhibiting p300/CBP influences androgen receptor expression, which plays a role in the development of late-stage prostate cancer. It is also believed that targeting the conserved bromodomain pockets of p300/CBP may enable the best balance of selectivity, potency, and desired effects for inobrodib treatment.

In the open-label, phase 1/2a trial, investigators are assessing inobrodib monotherapy in cohorts of patients with non-Hodgkin lymphoma or multiple myeloma, AML or higher risk MDS, and those with non-Hodgkin lymphoma or peripheral T-cell lymphoma. Treatment evaluation also includes inobrodib in combination with pomalidomide plus dexamethasone among patients with multiple myeloma and inobrodib plus azacitidine (Vidaza) and venetoclax (Venclexta) in patients with AML or higher risk MDS.

The primary end points of the trial include treatment-related adverse effects and incidence of laboratory abnormalities. Secondary end points include the response rate, duration of response, area under the plasma concentration time curve of inobrodib, and the maximum observed plasma concentration.

Patients 18 years and older with an ECOG performance status of 0 to 2 and a confirmed diagnosis of a relapsed or refractory hematologic malignancy are eligible for enrollment on the trial. Additional eligibility criteria include receiving previous standard therapy and having adequate organ function.

Patients who receive intervention with any chemotherapy, investigational agents, or other anti-cancer treatment within 14 days of beginning study treatment are not able to enroll on the trial. Patients are also unsuitable for enrollment if they have major surgical procedures within 4 weeks of beginning study treatment, any unresolved reversible toxicities from prior therapy, any evidence of severe or uncontrolled systemic diseases, or any known uncontrolled intercurrent illness.

References

  1. CellCentric receives FDA fast track designation for inobrodib for the treatment of patients with relapsed refractory multiple myeloma. News release. CellCentric. June 13, 2023. Accessed June 13, 2023. bit.ly/43Vr481
  2. Inobrodib: a first in class oral anti-cancer drug. CellCentric. Accessed June 13, 2023. bit.ly/3N7NoVd
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