Genentech has reported positive results from its Phase III CLL14 trial after meeting the primary endpoint of progression-free survival (PFS).
The trial analysed fixed-duration venclexta (venetoclax) in combination with gazyva (obinutuzumab) for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions.
During the trial, 432 patients were randomly distributed to receive either venclexta plus gazyva (Arm A) or gazyva plus chlorambucil (Arm B).
Results demonstrated a statistically significant reduction in the risk of disease worsening or death compared to standard-of-care gazyva plus chlorambucil, as assessed by the investigator.
No new safety signals or increase in known toxicities of venclexta or gazyva were reported among the patients treated with the drug combination.
The CLL14 study’s secondary endpoints include best overall response, complete response, duration of response and overall survival.
Genentech chief medical officer and global product development head Sandra Horning said: “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.
“CLL14 is the first study to show superior progression-free survival for venclexta plus gazyva compared to a standard-of-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.”
Venclexta is a small molecule that is capable of selectively binding and inhibiting the BCL-2 protein, which plays an important role in the programmed cell death process.
In collaboration with AbbVie, Genentech is currently developing venclexta, which is used to treat people with CLL or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.