Venetoclax (Venclexta) in combination with azacytidine met its dual primary endpoints of overall survival and composite complete remission rate in a phase III VIALE-A study, according to a Genentech press release.
The combination showed a statistically significant improvement in overall survival for people with previously untreated acute myeloid leukemia, who were also ineligible for intensive induction chemotherapy. The results were significant compared to treatment with azacytidine, a hypomethylating agent, alone.
“Acute myeloid leukemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health,” Levi Garraway, MD, PhD, chief medical officer and head of global product development said in a press release. “These data validate the benefit that this Venclexta-based combination can bring to patients and we look forward to discussing the results with health authorities.”
The results were from the VIALE-A phase III randomized, double-blind, placebo-controlled multicenter study that analyzed the efficacy and safety of the venetoclax and azacytidine combination in patients with previously untreated acute myeloid leukemia. Of the 431 patients included in the study, two thirds of them received 400 mg of venetoclax, in combination with azacytidine, daily. The other third of the population received a placebo in combination with azacytidine.
Primary endpoints included overall survival and rate of complete remission. Secondary endpoints included event free survival, complete remission with partial hematologic recovery, transfusion independence and patient-reported outcomes.
The resulting data is expected to be shared with global health authorities and presented at an upcoming medical meeting. Venetoclax has been granted a total of 5 breakthrough therapy designations from the FDA to this point, while also being granted accelerated approval in the past.
Acute myeloid leukemia is the most common aggressive leukemia among adults, with an estimated 20,000 new cases diagnosed in the United States for the 2020 calendar year. Most patients of acute myeloid leukemia over the age of 60 are vulnerable to intensive chemotherapy for the disease, which has the lowest survival rate for all leukemia types.
Genentech Announces Venclexta Combination Improved Overall Survival in People With Previously Untreated Acute Myeloid Leukemia [news release]. San Francisco, California. Published March 23, 2020. https://www.gene.com/media/press-releases/14842/2020-03-23/genentech-announces-venclexta-combinatio. Accessed March 23, 2020.