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VIALE-A injects new vigour into AbbVie, Roche’s Venclexta

Trial shows combining Venclexta with azacitidine more effective than azacitidine alone


AbbVie and Roche’s Venclexta has bounced back from a failed trial in previously-untreated acute myeloid leukaemia (AML) after hitting the mark with a different chemotherapy combination.

The results of the VIALE-A trial showed that combining Venclexta (venetoclax) with azacitidine was more effective than azacitidine alone as a frontline therapy for adults with AML who weren’t eligible for standard, aggressive chemo.

Data from the study was described as “practice changing” by lead investigator Courtney DiNardo of MD Anderson Cancer Centre, while presenting the results at the European Haematology Association (EHA) virtual congress.

While standard treatment for AML is intensive induction chemo, some patients are not strong enough to tolerate this, and so get treated with a milder therapy based on either azacitidine or decitabine. Patient treated with these therapies typically only live for 9-10 months with complete remission (CR)/complete remission with incomplete count recovery (CRi) rates  of less than 40%.

In VIALE-A, adding Venclexta to azacitidine boosted overall survival to 14.7 months compared to 9.6 months with azacitidine on its own, with CR/Cri rates of 66% and 28%, respectively.

AbbVie and Roche have already filed for approval of Venclexta plus azacitidine in this setting, providing some comfort for the two partners after Venclexta flunked the VIALE-C trial of the BCL-2 inhibitor alongside low-dose cytarabine (LDAC).

The trial was intended to confirm that LDAC section of Venclexta’s 2018 FDA approval for Venclexta in first-line AML, which gave a green light for its drug alongside LDAC, azacitidine or decitabine.

As a condition of speedy approval, Roche and AbbVie committed to carrying out phase 3 trials with the combinations to confirm their efficacy. AbbVie has suggested VIALE-C failed to show a statistically significant improvement on survival because it was too small, and that its 25% improvement over LDAC alone means it should continue to be approved for this use.

Venclexta – known as Venclyxto in Europe – is also used as a first-line therapy for chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL)  in combination with Roche’s anti-CD20 drug Gazyva (obinutuzumab), and as a treatment for relapsed patients with CLL/SLL.

AbbVie posted sales of $792m for Venclexta last year, more than double the prior year with the approval in AML a key factor in its growth. With Roche, the company is also hoping to extend use of the drug into less frail AML patients as well as high-risk myelofibrosis.

AML is one of the most common forms of leukaemia in adults, with around 21,000 new cases in the US per year, and is also a particularly aggressive form of the disease.

Article by
Phil Taylor

15th June 2020

From: Research



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