Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia

• Long-term follow-up data from the phase III MURANO trial showed sustained progression-free survival with fixed-duration Venclexta/Venclyxto plus MabThera/Rituxan
• MURANO and phase III CLL14 trials confirm chronic lymphocytic leukaemia patients treated with Venclexta/Venclyxto-based regimens achieve higher rates of undetectable minimal residual disease*, which may be associated with a lower risk of future disease progression or death

             
Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta/Venclyxto (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020.

“These results reinforce the long-term value of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based combinations in CLL, potentially offering patients a significant period of time without treatment following initial therapy,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These data also reflect our ongoing commitment to accelerating clinical advancements for patients by exploring the novel endpoint minimal residual disease as a potential predictor of patient outcomes.”

Five-year data from the pivotal phase III MURANO trial continue to show sustained investigator-assessed progression-free survival (PFS) with Venclexta/Venclyxto plus MabThera/Rituxan (rituximab). Data, presented in an oral session, showed:

• Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 81% (HR= 0.19; 95% CI: 0.15, 0.26; p<0.0001) compared to bendamustine plus MabThera/Rituxan (BR) in people with relapsed or refractory (R/R) CLL.
• At the time of analysis, median overall survival (OS) had not been reached in either arm, however, five-year OS was 82.1% in the Venclexta/Venclyxto plus MabThera/Rituxan arm, compared to 62.2% in the BR arm (HR=0.40; 95% CI: 0.26, 0.62).
• In the Venclexta/Venclyxto arm, among the 130 patients who completed two years of treatment without progressive disease, 63.8% (n=83/130) had undetectable MRD (uMRD) levels at the end of treatment. In an analysis of this patient subgroup, uMRD was associated with improved progression-free survival. Undetectable MRD, sometimes referred to as MRD-negativity, means that no cancer cells could be detected using a specific and highly sensitive test, and is defined as less than one cancer cell in 10,000 leukocytes.
• No new safety events were reported in the study.¹