Roche has announced updated results from its pivotal CLL11 multicentre, open-label, randomized clinical trial confirming that Gazyva/Gazyvaro (obinutuzumab) in combination with chlorambucil in previously untreated Chronic Lymphocytic Leukaemia (CLL) patients significantly reduced the risk of disease deterioration or death by over a half in comparison to MabThera/Rituxan (rituximab) combined with chlorambucil.
The results, presented during the Annual Meeting of the American Society of Hematology (ASH), December 5-8 in Orlando, Florida, were from a secondary endpoint that assessed time to next treatment (TTNT) revealing that following completion of a six-month Gazyva/Gazyvaro regimen, patients remained free from treatment for approximately four years on average before needing their next cancer treatment. The progression-free survival (PFS) was of 28.7 months versus 15.7 months and researchers reported no unexpected safety signals.
“These updated CLL11 data confirmed that Gazyva/Gazyvaro helped people with previously untreated chronic lymphocytic leukaemia live significantly longer without disease worsening or death compared to MabThera/Rituxan,” Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said in a press release. “After a fixed course of therapy with Gazyva/Gazyvaro, people remained treatment-free for nearly four years on average. Time free from treatment is an important consideration for a disease like CLL, which occurs in older adults who frequently have other health issues. ”
GAZYVA is a type of antibody therapy that targets and attaches to the CD20 protein found on the surface of both CLL cells and some healthy blood cells. Chlorambucil is a chemotherapy drug used mainly to treat CLL, low grade non Hodgkin lymphoma and Hodgkin lymphoma.
Data from the GREEN study, an ongoing Phase IIIb safety study evaluating the safety and efficacy of Gazyva/Gazyvaro alone or in combination with chemotherapy, including bendamustine, in people with previously untreated or relapsed/refractory CLL, was also presented. The primary endpoint of the study was safety and secondary endpoints were overall response rate (ORR) and minimal residual disease (MRD) negativity.
Trial results revealed no unexpected safety signals when Gazyva/Gazyvaro was used in combination with bendamustine. Additionally, approximately 80% of the patients taking part in the study responded to Gazyva/Gazyvaro in combination with bendamustine and 32.3% of the patients reached complete response. A substantial proportion of treated patients were minimal residual disease(MRD) negative in the blood or in the bone marrow (59% and 28%, respectively), meaning that no cancer could be detected using a specific test.
Gazyva/Gazyvaro used in combination with chlorambucil is approved in the US for people with previously untreated CLL and in the EU it is approved for the treatment of patients with previously untreated CLL who have other comorbidities, which means they are ineligible for an intensive treatment (full-dose fludarabine based therapy).