Ongoing Phase III Trial Compares Venetoclax With Standard Therapy for Resistant Myeloma
Posted: Wednesday, August 5, 2020
The phase III, open-label CANOVA trial evaluating the selective oral BCL2 inhibitor venetoclax in the treatment for patients with relapsed or refractory multiple myeloma to the standard therapy of pomalidomide, is underway, according an abstract from the ASCO20 Virtual Scientific Program (Abstract TPS8554). The two treatments are being evaluated in combination with dexamethasone, noted Maria-Victoria Mateos, PhD, of Hospital Clinico Univ de Salamanca, Salamanca, Spain, and colleagues.
“Notably, t(11;14)-positive multiple myeloma is more dependent on BCL2 for cell survival, which, together with these clinical data, suggest that venetoclax combined with dexamethasone may provide greater clinical benefit versus standard therapies, like pomalidomide, in this biomarker-defined patient population,” the authors explained.
In this randomized, multicenter study, the authors are enrolling patients with t(11;14)-positive relapsed or refractory multiple myeloma. To be eligible, patients must have an Eastern Cooperative Oncology Group performance status score of no more than 2, have received at least two prior lines of therapy, have previously received a proteasome inhibitor, and must have disease refractory to lenalidomide and the last line of therapy. Patients can also not have been previously treated with venetoclax, pomalidomide, or any other BCL2 inhibitors.
The patients will receive either 800 mg of venetoclax a day or 4 mg of pomalidomide per day, with both groups also being treated with 40 mg of dexamethasone once a week. The final progression-free survival analysis will be performed when approximately 147 progression-free survival events are observed by the study authors. Secondary endpoints are response rate, patient-reported outcomes, overall survival, duration of response, times to response and disease progression, minimal residual disease negativity rate, safety, and venetoclax pharmacokinetics.
As of January 2020, 28 patients had been enrolled and randomly selected for treatment.
Disclosure: For a full disclosure of the study authors, visit coi.asco.org.
