AbbVie: 4-year Follow-up Analysis Of Phase 3 Venetoclax Trial Continues To Show Longer PFS In CLL

AbbVie (ABBV) announced Friday results from a four-year follow-up analysis of the Phase 3 CLL14 trial. The new data shows that AbbVie’s VENCLYXTO/VENCLEXTA fixed duration combination demonstrates sustained progression-free survival or PFS in chronic lymphocytic leukemia or CLL patients after three years off treatment.

CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes are found predominantly in the blood and bone marrow.

The data showed that previously untreated patients with CLL with coexisting conditions who were treated with VENCLYXTO/VENCLEXTA (venetoclax) plus obinutuzumab continued to show longer PFS and higher rates of undetectable minimal residual disease or MRD compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.

The data were presented for the first time during the virtual 26th European Hematology Association Annual Congress.

Mohamed Zaki, vice president and head, global oncology development, AbbVie, “The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment.”

The most frequently occurring serious adverse reactions in patients receiving venetoclax in combination with obinutuzumab were pneumonia, sepsis, febrile neutropenia, and TLS.

VENCLYXTO/VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

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