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AbbVie’s Venclexta plus azacitidine shows improved survival and remissions rates in leukaemia patients

pharmafile | June 15, 2020 | News story | Sales and Marketing AbbVie, leukaemia 

AbbVie have announced positive results from its latest Phase 3 clinical trial where Venclexta plus azacitidine improved survival and remission rates in treatment-naïve acute myeloid leukaemia patients (AML).

The VIALE-A trial showed that the drug combination achieved a 34% reduction in the risk of death compared to azacitidine in combination with a placebo. It also improved median survival with 14.7 months with the drug combination versus 9.6 months with the placebo, and 66.4% of patients treated with the combination also had a complete remission compared to 28.3% in the placebo patients.

The trial evaluated efficacy and safety of the combination in acute myeloid leukaemia patients who are ineligible for standard induction therapy. The trial met its primary endpoints of improvement and complete remission. The data was presented for the first time during the 25th European Hematology Association Annual Congress which was presented virtually due to the pandemic.

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

AML is the common form of acute leukaemia, with an estimated 160,000 people currently living with the disease , with it being one of the most difficult blood cancers to treat. It usually worsens with age and not all patients can tolerate induction chemotherapy.

Dr Courtney D. DiNardo, Department of Leukemia, Division of Cancer Medicine at MD Anderson and the lead study investigator, said: “AML is a challenging blood cancer marked by low survival rates – especially among older patients who are not eligible for intensive induction chemotherapy – which leaves them with few treatment options.

“The VIALE-A results provide further insights in venetoclax to significantly extend overall survival and achieve better response rates than azacitidine alone. Venetoclax in combination with azacitidine is an effective therapeutic approach for previously-untreated AML in patients who cannot withstand chemotherapy.”

Conor Kavanagh

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