AbbVie's Venclexta and Chemo Combination Decreases Death by 34% in AML

AbbVie reported positive results from the VIALE-A clinical trial of Venclex

ta plus azacytidine in previously untreated acute myeloid leukemia (AML) patients who were ineligible for intensive chemotherapy.

The trial showed a 34% decrease in the risk of death compared to azacytidine in combination with placebo alone. Patients receiving the venetoclax combination showed improved median overall survival of 14.7 months compared to 9.6 months in the placebo arm and 66.4% of patients receiving the combination had a composite complete remission compared to 28.3% with the azacytidine-placebo arm.

Venclexta/Venclyxto (venetoclax) is a first-in-class drug that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. It is being developed by AbbVie and Roche and jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S., and by AbbVie outside the U.S. The drug is approved in more than 50 countries for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), in combination with azacitidine or decitabine or low-dose cytarabine in newly diagnosed AML.

“Patients living with AML may be too sick to endure chemotherapy, and they face one of the most aggressive types of blood cancer,” said Neil Gallagher, chief medical officer of AbbVie. “The positive results from the VIALE-A study underscore the significant impact venetoclax plus azacytidine can have on improved survival and complete response in a previously-untreated patient population.”

In addition to meeting the primary endpoint, the trial met all secondary endpoints, with a complete response rate of 36.7%, a complete response rate with partial hematologic recovery of 64.7% and a composite complete remission rate of 66.4%. The safety profile was consistent with the known safe profiles.

AML is the most common acute leukemia. About 160,000 people are living with the disease around the world and there is an incidence rate of 103 new cases per 100,000 people. It is also one of the most difficult blood cancers to treat. The five-year survival rate for patients diagnosed with AML is about 28%. The disease typically gets worse quickly, and because of age and comorbidities, not all patients can tolerate intensive induction chemotherapy.

“When you don’t treat these people, they might live about three months,” said Mohamed Zaki, vice president and global head of hematology development at AbbVie. “We’re talking about a death sentence.”

Approximately 20% to 30% of patients have even less time, “so we’re dealing with a ticking bomb—a patient where we’re just running around trying to help them in any way we can.” The combination, he adds, has “clear potential to change how we are treating the patients and what benefits we can bring to them in the future.”

Allergan Aesthetics, an AbbVie company, also announced today that the U.S. Food and Drug Administration (FDA) approved Juvederm Voluma XC for the augmentation fo the chin to improve the chin profile in adults over the age of 21. It is the first and only filler to receive FDA approval for the augmentation of the chin region. It is the second indication approved for the drug, which was approved in 2013 for cheek augmentation to correct age-related mid-face volume deficit.