At the ASH meeting in Atlanta this morning, AbbVie and Genentech unveiled stellar results of its Phase III combination trial of Venclexta and Rituxan to treat patients with relapsed or refractory CLL.
At the American Society of Hematology meeting in Atlanta this morning, AbbVie and Genentech unveiled stellar results of its Phase III combination trial of Venclexta and Rituxan to treat patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Patients in the study who received Venclexta plus Rituxan lived significantly longer without their disease worsening in comparison to the standard of care. Results from the Phase III Murano trial showed that a fixed duration of treatment with this chemotherapy-free combination significantly reduced the risk of disease progression or death by 83 percent compared with bendamustine plus Rituxan (BR), which is a current standard of care. Data released today by both companies show 24-month PFS of 84.9 percent for the AbbVie/ Genentech combination compared to 36.3 percent against the standard of care. The companies said consistent improvement in PFS was observed across the patient subgroups assessed in the trial. Not only that, but data from the joint trial showed complete response rate for the combination therapy was 26.8 percent compared to 8.2 percent for standard of care.
Michael Severino, AbbVie’s chief scientific officer and head of R&D, said the data from the Phase III trial represents the “next evolution” in a potential treatment option for patients with relapsed/refractory CLL. Severino added that both companies are working with regulatory agencies to spur approval of the combination therapy. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL.
“The Murano study results indicate that Venclexta plus Rituxan has the potential to provide an important new chemotherapy-free option for people with previously treated chronic lymphocytic leukemia,” Sandra Horning, Genentech’s chief medical officer and head of global product development, said in a statement. “We are particularly encouraged by the magnitude of benefit observed across key efficacy measures compared to a current standard of care, and we look forward to discussing these results with health authorities.”
In April 2016, the FDA approved Venclexta for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA approved drug to target the BCL-2 protein. Genentech and AbbVie also co-developed the drug for this indication.
Chronic lymphocytic leukemia is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States diagnosed by the end of this year.
“Based on the efficacy and safety results of this trial, the Venclexta and Rituxan combination has the potential to offer a new chemotherapy-free regimen for patients with relapsed/refractory CLL. We continue to monitor safety and efficacy in trial patients to gain further data and information.” John Seymour, lead investigator of the Murano trial, said in a statement.
