BT-062, an antibody drug conjugate (ADC) is in clinical development for treating patients with relapsed/refractory multiple myeloma. BT-062 as monotherapy had shown good tolerability in two clinical trials investigating various dose schedules in addition to anti-tumor activity.
Multiple myeloma patients are administered a variety of combination therapies to improve overall response rates. BT-062 has been found to increase efficacy when combined with lenalidomide in preclinical studies, suggesting a synergistic effect on tumor cells.
German pharmaceutical company, Biotest, is expanding BT-062 development into combination therapy. The phase I/IIa studies would evaluate and investigate the efficacy of the ADC in combination with lenalidomide and dexamethasone when administered to patients on days 1, 8, and 15 in a 4 week cycle.
In January 2012, The Myeloma Beacon had reported the activity of the antibody-drug conjugate, BT-062 in patients with advanced multiple myeloma in a small phase 1 clinical trial. Dr.Sundar Jagannath of Mount Sinai Medical Center, New York City presented the results of the trial at the 2011 American Society of Hematology.
The Phase 1 study was designed to determine the safety and efficacy of BT-062 and to determine its maximum tolerated dose in a small number of relapsed/refractory multiple myeloma patients.
The study included 32 patients who had received a median of seven prior anti-myeloma therapies. All patients had previously failed treatment with at least one immunomodulatory agent, such as Revlimid(lenalidomide) or thalidomide (Thalomid), and at least one protease inhibitor, such as Velcade (bortezomib) or carfilzomib (Kyprolis).
Participants received treatment with one of seven doses of BT-062, ranging from 10 mg/m2 to 200 mg/m2.
Of the 28 patients who were evaluated for response, 4 percent achieved a partial response, 8 percent had a minor response, and 38 percent showed stable disease.
The maximum tolerated dose was 200 mg/m2, with mucositis (inflammation and ulceration of the mucous membranes lining the digestive tract) being the dose-limiting side effect.
Side effects included mucositis, hand-foot syndrome, blurred vision, and dry eyes, with the last two side effects primarily reported at very high doses.
Dr. Jagannath reported that most patients discontinued treatment due to disease progression, not side effects.
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