New Drug Will Be Studied in Relapsed/Refractory Myeloma, Other Blood Cancers


The myeloma treatment group of the COVALENT-101 clinical trial recently started, analyzing the new drug BMF-219 in patients with relapsed or refractory disease.

The first patient with multiple myeloma has been dosed in the phase 1 COVALENT-101 clinical trial, which is evaluating BMF-219 in patients with certain types of blood cancers that have relapsed or are refractory toward other treatments, according to Biomea Fusion, Inc., the manufacturer of the covalent menin inhibitor.

COVALENT-101 is a dose-escalation and dose-expansion study geared toward finding the right dose of BMF-219, as well as studying its safety, tolerability and how it moves and works within the body to fight cancer.

The drug will be administered at increasing doses until the patient experiences a grade 2 or higher side effect (moderate or worse) or has a dose-limiting toxicity. Then, treatment will continue in 28-day cycles until disease progression or BMF-219 becomes intolerable.

“Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. This represents the second cancer type, as well as the first cancer type outside of (acute myeloid leukemia), to be studied with BMF-219,” Tomas Butler, CEO of Biomea, said in a press release.

BMF-219 is also being studied in the relapsed/refractory setting for the following diseases: acute myeloid leukemia, acute lymphoblastic leukemia and diffuse large B-cell lymphoma.

To be eligible for enrollment in COVALENT-101 (which is recruiting in cancer centers across the United States), patients must have experienced disease progression on or are ineligible for other therapies. Their ECOG performance status must be 2 or lower, meaning that they can perform all of their daily activities with little to no assistance, and have adequate organ function.

Patients who have central nervous system disease, received prior menin inhibitor treatment or who have known clinically significant cardiovascular disease will not be eligible for COVALENT-101.

According to the press release, BMF-219 is the first menin inhibitor to be given to patients with relapsed/refractory myeloma. The drug works by stopping menin, which is a protein that can play a role in tumor proliferation in myeloma and other blood cancers.

“From the very beginning of our journey, we have been exploring and validating the broad potential of covalently inhibiting the scaffold protein, menin, in a host of liquid and solid tumors,” said Dr. Steve Morris, chief medical officer of Biomea Fusion, in the press release. “Menin’s broad role in a variety of tumor types is rather striking. Based on the outstanding translational work of our team, we have seen compelling preclinical activity using BMF-219 in MM subtypes, especially those that are driven by MYC, a protein essential to the growth of numerous tumor types.”

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