Roche reports positive results from CLL11 study of obinutuzumab

18th June 2018 (Last Updated June 18th, 2018 00:00)

Roche has reported positive results from the final analysis of the phase III study CLL11 assessing Gazyva/Gazyvaro (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL).

Roche has reported positive results from the final analysis of the phase III study CLL11 assessing Gazyva/Gazyvaro (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL).

The multi-centre, open-label, randomised three-arm investigated the safety and efficacy profile of Gazyva/Gazyvaro plus chlorambucil in comparison with MabThera/Rituxan plus chlorambucil or chlorambucil alone in nearly 800 people with previously untreated CLL and comorbidities.

The study’s primary endpoint is progression-free survival (PFS) and secondary endpoint included response rate, molecular remission rate, overall survival (OS), TTNT and safety profile.

Final results after a follow-up of nearly five years showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including PFS and OS, when compared with MabThera/Rituxan (rituximab) plus chlorambucil.

Roche noted that the treatment with Gazyva/Gazyvaro reduced the risk of death by 24% compared to MabThera/Rituxan-based treatment.

"This meaningful survival benefit compared to MabThera/Rituxan-based therapy reinforces that Gazyva/Gazyvaro-based therapy is an important option for people with previously untreated CLL."

Roche chief medical officer and Global Product Development head Sandra Horning said: “We are very pleased that the majority of patients treated with Gazyva/Gazyvaro are still alive after nearly five years of follow-up in the CLL11 study.

“This meaningful survival benefit compared to MabThera/Rituxan-based therapy reinforces that Gazyva/Gazyvaro-based therapy is an important option for people with previously untreated CLL.”

The final analysis of the CLL11 study demonstrated a reduction in the risk of disease progression or death of 51% for patients treated with Gazyva/Gazyvaro plus chlorambucil, clinically meaningful improvement in OS for patients receiving the combination and a prolonged time to initiation of the next therapy.

Patients also achieved a higher rate of minimal residual disease negativity versus those treated with MabThera/Rituxan plus chlorambucil.

At present, Gazyva/Gazyvaro is approved in more than 90 countries in combination with chlorambucil for people with previously untreated CLL, based on previously reported data from the CLL11 study.