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NORTH CHICAGO, Ill., June 9, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new findings demonstrating sustained long-term safety and efficacy of VENCLYXTO®/ VENCLEXTA® (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL. The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
"Results from the CLL14 and MURANO studies demonstrate the long-term benefits of fixed-duration venetoclax combinations for patients living with CLL," said Mariana Cota Stirner, M.D., Ph.D., vice president, hematology, AbbVie. "These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off treatment."
CLL14 Long-Term Analysis
New six-year follow-up results from the Phase 3 CLL14 study showcase updated outcomes in previously untreated patients with CLL and co-existing conditions. Patients treated with fixed-duration venetoclax plus obinutuzumab continued to experience improved PFS (95% Confidence Interval (CI) 0.31-0.52; Hazard Ratio (HR) 0.40) and higher rates of undetectable minimal residual disease (uMRD) when treated with fixed-duration venetoclax plus obinutuzumab compared to those who received chlorambucil plus obinutuzumab (53.1% vs 21.7%, respectively).
The data also showed significantly improved rates of time to next treatment (TTNT) with venetoclax plus obinutuzumab at 65.2 percent (95% CI 0.33-0.58; HR 0.44) compared to chlorambucil plus obinutuzumab at 37.1 percent.1 The observed differences in PFS and TTNT benefits between venetoclax-based treatment and chemoimmunotherapy were maintained across all risk groups, including patients with high-risk molecular features of CLL.
No new safety signals were observed in this six-year analysis. The most frequently occurring Grade 3 (≥2%) adverse events (AEs) in patients receiving the venetoclax-based combination were neutropenia, thrombocytopenia, infusion-related reaction (during treatment), anemia, febrile neutropenia, pneumonia and leukopenia.1
"The latest findings show that patients can experience long-term disease control, five years after stopping treatment," said Othman Al-Sawaf, M.D., investigator in the CLL14 study, hematologist-oncologist at the University Hospital Cologne in Germany, and study physician at the German CLL Study Group. "These results confirm the treatment benefits of fixed-duration venetoclax and obinutuzumab for previously untreated CLL patients with co-existing conditions."
Results will also be featured at EHA's Press Briefing.
MURANO Long-Term Analysis
Final data from the Phase 3 MURANO trial showcase that R/R CLL patients treated with two-year fixed-duration venetoclax plus rituximab sustained significantly longer median PFS at 54.7 months (95% CI 52.3, 59.9), the study's primary endpoint, compared to 17.0 months (95% CI 15.5, 21.7; HR 0.23) with bendamustine plus rituximab after 7 years of median follow-up.2
Seven-year OS rates were 69.6 percent (95% CI 62.8, 76.5) for patients treated with the venetoclax-based combination versus 51 percent (95% CI 43.3, 58.7) for study participants who received bendamustine-based combination (HR 0.53).2 Furthermore, most of the patients treated with the full two-year venetoclax-based combination achieved uMRD (70.3%) at the end of their treatment course, and those patients were shown to have improved PFS and OS compared to patients with detectable MRD (29.7%).
The safety profile of the venetoclax-rituximab combination is consistent with the known safety profile of each individual therapy alone. No new serious safety issues were observed in the MURANO updated analysis. The most common adverse reactions (ARs) (≥20%) of any grade were neutropenia, diarrhea, upper respiratory tract infection, fatigue, and nausea.
"We are pleased to find that uMRD was associated with prolonged PFS in R/R CLL patients after seven years," said study investigator Prof. John Seymour, Director of the Integrated Haematology Department of the Peter MacCallum Cancer Center and the Royal Melbourne Hospital in Melbourne. "Overall, these findings continue to support the use of treatment with venetoclax plus rituximab in this patient population."
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.
About the CLL14 Phase 3 Trial1,3The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLYXTO/VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and co-existing medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance
