ASCO: Combo Regimen Effective in CLL With Coexisting Conditions
TUESDAY, June 4, 2019 -- Venetoclax-obinutuzumab is associated with longer progression-free survival than chlorambucil-obinutuzumab among patients with untreated chronic lymphocytic leukemia (CLL) and coexisting conditions, according to a study published online June 4 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American Society for Clinical Oncology, held from May 31 to June 4 in Chicago.
Kirsten Fischer, M.D., from the University Hospital of Cologne in Germany, and colleagues conducted an open-label phase 3 trial to examine fixed-duration treatment with venetoclax and obinutuzumab in patients with previously untreated CLL and coexisting conditions. Patients with a score of ≥6 on the Cumulative Illness Rating Scale or a calculated creatinine clearance of less than 70 mL/minute were randomly assigned to venetoclax-obinutuzumab (216 patients) or chlorambucil-obinutuzumab (216 patients).
The researchers found that 30 and 77 primary end-point events (disease progression or death) had occurred in the venetoclax-obinutuzumab and chlorambucil-obinutuzumab groups, respectively, after a median follow-up of 28.1 months (hazard ratio, 0.35). The percentage of patients with progression-free survival at 24 months was significantly higher in the venetoclax-obinutuzumab group versus the chlorambucil-obinutuzumab group (88.2 versus 64.1 percent). For patients with TP53 deletion, mutation, or both and in patients with unmutated immunoglobulin heavy-chain genes, the benefit was also observed. There was no significant difference in all-cause mortality between the groups (9.3 and 7.9 percent, respectively).
"Longer follow-up is necessary to assess the durability of the responses," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including F. Hoffmann-La Roche and AbbVie; AbbVie manufactures venetoclax and funded the study.
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Posted: June 2019
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