Roche has secured approval from the US Food and Drug Administration (FDA) for its Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) to treat people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Venclexta/Venclyxto is a first-in-class targeted medicine that will selectively bind and restrict the B-cell lymphoma-2 (BCL-2) protein, while Gazyva/Gazyvaro is an engineered monoclonal antibody that will attach to CD20, a protein expressed on certain B cells
FDA approval was based on data from the randomized phase III CLL14 study, which assessed 12-month and fixed-duration treatment with Venclexta plus Gazyva compared against Gazyva plus chlorambucil.
According to the company, the results demonstrated that the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death(progression-free survival [PFS] compared to Gazyva plus chlorambucil.
AbbVie and Roche were involved in the development of Venclext. AbbVie and Roche group member Genentech have taken responsibility to commercialize Venclexta in the US, while AbbVien alone is responsible for commercialization outside of the US.
The CLL14 is a randomized phase III study designed to assess the combination of fixed-duration Venclexta plus Gazyva compared against patients with previously untreated CLL and co-existing medical conditions.
The trial randomly assigned 432 patients with previously untreated CLL to secure either a 12-month duration of Venclexta alongside six-month duration of Gazyva (Arm A) or six-month duration of Gazyva plus chlorambucil followed by an additional six-month duration of chlorambucil (Arm B).
The trial’s primary endpoint is investigator-assessed PFS, while secondary endpoints comprise of PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response (OR), complete response (with or without complete blood count recovery, CR/CRi), overall survival (OS), duration of response (DOR), event-free survival (EFS), time to next CLL treatment (TTNT) and safety.
Roche chief medical officer and global product development head Dr Sandra Horning said: “Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care.
“Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia.”