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BREAKING NEWS
Source: Roche  Nov 05, 2018  5 years, 5 months, 1 week, 5 days, 18 hours, 28 minutes ago

Phase III data showed that Venclexta Venclyxto plus Gazyva Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities

Phase III data showed that Venclexta Venclyxto plus Gazyva Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities
Source: Roche  Nov 05, 2018  5 years, 5 months, 1 week, 5 days, 18 hours, 28 minutes ago

 • The phase III CLL14 study compared Venclexta/Venclyxto in combination with Gazyva/Gazyvaro to standard-of-care Gazyva/Gazyvaro plus chlorambucil
 • Data will be submitted to health authorities and presented at an upcoming medical meeting
 
 

Basel,

1 November 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the randomised phase III CLL14 study, which evaluated fixed-duration Venclexta®/Venclyxto® (venetoclax) in combination with Gazyva®/Gazyvaro® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (PFS; as assessed by investigator) compared to standard-of-care Gazyva/Gazyvaro plus chlorambucil. The results showed that no new safety signals or increase in known toxicities of Venclexta/Venclyxto or Gazyva/Gazyvaro were observed with the treatment combination.
 
“People with chronic lymphocytic leukaemia continue to need more treatment options because some patients are unable to tolerate chemotherapy regimens due to their underlying health,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “CLL14 is the first study to show superior progression-free survival for Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to a standardof-care regimen. We will work with health authorities to bring this potential chemotherapy-free treatment option to people who need it as quickly as possible.”
 
Data from the CLL14 study will be submitted to global health authorities. Venclexta in combination with Rituxan® (rituximab) has been approved by the US Food and Drug Administration (FDA) for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Venclyxto in combination with MabThera® (rituximab) has recently been approved in Europe for people with previously treated CLL, who have received at least one prior therapy, based on results from the randomised phase III MURANO study.
 
A robust clinical development programme for Venclexta/Venclyxto is ongoing in several types of blood cancer, including acute myeloid leukaemia and multiple myeloma. Gazyva/Gazyvaro continues to be investigated in combination with approved and investigational Roche and non-Roche molecules in CLL and follicular lymphoma.
 
Venclexta/Venclyxto (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

About the CLL14 study

CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil in patients with previously untreated chronic lymphocytic leukaemia (CLL) with coexisting medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either Venclexta/Venclyxto plus Gazyva/Gazyvaro (Arm A) or Gazyva/Gazyvaro plus chlorambucil (Arm B). The primary endpoint of the study is investigator-assessed progression free survival (PFS). Secondary endpoints include PFS assessed by independent review committee, best overall response, complete response, duration of response, overall survival, event-free survival, time to next CLL treatment, minimal residual disease status and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.