AbbVie has treated the first subject in the Phase III CERVINO clinical trial of its investigational product ABBV-383 to treat relapsed/refractory multiple myeloma (r/r MM).
ABBV-383 is a bispecific antibody T-cell engager that binds to both BCMA and CD3, designed to target and engage T-cells to fight cancer cells.
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The multi-centre, open-label, randomised, global trial is designed to assess ABBV-383 against standard available therapies.
It will enrol 380 adult patients with r/r MM who have received a minimum of two lines of treatment previously, including proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAb).
Those previously treated with BCMA-targeted therapies will not be eligible for the trial.
Trial subjects will be randomised into a 1:1 ratio to receive either ABBV-383 administered intravenously every four weeks or the investigator’s choice of standard available therapy (SAT).
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By GlobalDataThe SAT options include combinations of carfilzomib and dexamethasone, elotuzumab with pomalidomide and dexamethasone, or selinexor with bortezomib and dexamethasone.
The company plans to enrol subjects at nearly 140 sites across the globe.
Progression-free survival and overall response rate are the trial’s dual primary endpoints.
Overall survival, complete response or better, very good partial response or better, the rate of minimum residual disease negativity and changes in disease symptoms and physical functioning comprise secondary endpoints.
AbbVie oncology, haematology therapeutic area head and vice-president Mariana Cota Stirner said: “The start of the CERVINO Phase III trial marks an important step forward in AbbVie’s continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients.
“ABBV-383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximising treatment simplicity for physicians and patients, if proven in the clinical trials.”
In April, the company reported positive top-line data from the first period of the Phase III SELECT-GCA study of upadacitinib plus a steroid taper regimen in adults with giant cell arteritis (GCA).
