New data demonstrates Venclyxto/Venclexta combination sustained progression-free survival in chronic lymphocytic leukemia after four years of treatment.
AbbVie announced five-year follow-up results from the Phase III CLL14 trial, finding that over 60 percent of patients with previously untreated chronic lymphocytic leukemia (CLL) who had received one-year fixed-duration combination treatment of Venclyxto/Venclexta (venetoclax) plus obinutuzumab (Gazyva) continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) after four years off treatment.
The findings were presented at the 2022 European Hematology Association (EHA) Annual Congress (Abstract #S148).
"Long-term data from the CLL14 trial show that the one-year fixed-duration combination regimen of venetoclax and obinutuzumab offers patients the possibility of four years of CLL treatment-free response without disease progression," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology clinical development, AbbVie. "Since its approval, this chemotherapy-free combination option has helped transform the therapeutic landscape for CLL."
Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the Venclyxto/Venclexta and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemotherapy regimen (n=432; median NR vs 36.4 months; hazard ratio [HR] 0.35 [95% CI 0.26-0.46], p<0.0001). the therapies were administered for a fixed-duration of 12 months for venclyxto venclexta in combination with six cycles of obinutuzumab. at five years after randomization, the estimated pfs rate after one-year fixed-duration treatment was 62.6 percent for the venclyxto venclexta-based combination compared to 27.0 percent for the chlorambucil combination. the improvement in pfs was maintained across all risk groups, including patients with tp53 mutation deletion and unmutated ighv status.
Among the secondary endpoints, patients were assessed for MRD in peripheral blood and/or bone marrow, using next generation sequencing. Undetectable MRD (uMRD) was defined as less than one CLL cell being identified per 10,000 lymphocytes sampled. Four years after treatment completion, 18.1 percent of patients treated with the Venclyxto/Venclexta-based combination still had uMRD compared to 1.9 percent of patients in the chlorambucil combination study arm. The estimated overall survival (OS) rate was 81.9 percent in the Venclyxto/Venclexta-based combination and 77.0 percent in the chlorambucil combination group (HR 0.72 [0.48-1.09], p=0.12) at five years after randomization.
No new safety signals were observed in the five-year follow-up analysis. The most frequently occurring serious adverse reactions (>=2%) in patients receiving the Venclyxto/Venlexta-based combination were pneumonia, sepsis, febrile neutropenia, and tumor lysis syndrome.
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