AbbVie-Roche's Venclexta Shows Progression-Free Survival Of 74% In CLL Patients After Three Years Treatment

  • Genentech, a unit of Roche Holdings AG RHHBY, and its collaborating partner AbbVie Inc ABBV have announced long-term follow-up data from two Phase 3 trials of Venclexta (venetoclax) in chronic lymphocytic leukemia (CLL). A post-hoc analysis from a Phase 3 trial in AML was also presented.
  • Data will be presented at the European Hematology Association Virtual Congress.
  • The four-year posthoc analysis of investigator-assessed progression-free survival (PFS) had a median follow-up of 52.4 months.
  • The study indicated that the chemotherapy-free Venclexta plus Gazyva (obinutuzumab) regimen had an estimated progression-free survival (PFS) of 74.0% vs. 35.4% for Gazyva plus chlorambucil.
  • The time to subsequent treatment (TTNT) was significantly longer among patients treated with the Venclexta plus Gazyva regimen versus the comparator (four-year TTNT 81.1% versus 59.9%).
  • Furthermore, 30 months after the end of treatment, 26.9% of the Venclexta-treated patients still had undetectable minimal residual disease compared with 3.2% of those treated with the comparator.
  • The most common serious/severe adverse events with Venclexta and Gazyva at 28 months follow-up were low white blood cell count and infections.
  • The European Commission recently approved Venclyxto for newly diagnosed acute myeloid leukemia combined with a hypomethylating agent, azacitidine or decitabine.
  • Price Action: ABBV shares are down 0.57% at $115.56 during the market session on the last check Friday.
  • Editor's note: The first bullet has been updated to correct 'three phase 3 trials' to '2 Phase 3 trials and one post-hoc analysis.'
Posted In: BiotechNewsHealth CareFDAGeneralBriefsleukemia