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AbbVie and Roche plan Venclexta combo filings in leukaemia

MURANO trial shows the duo’s treatment extends PFS

abbvieAbbVie and Roche's long-anticipated combination trial of Venclexta/Venclyxto and Rituxan in chronic lymphocytic leukaemia, setting up regulatory filings for the duo.

The phase III MURANO trial pithed the combination of Venclexta (venetoclax) plus Rituxan (rituximab) against chemotherapy drug bendamustine plus Rituxan in patients with relapse/refractory CLL, and showed that AbbVie's drug extended progression-free survival (PFS).

There are no further details on the data available just yet, but AbbVie says intends to move quickly ahead with regulatory filings for first-in-class BCL-2 inhibitor Venclexta plus Rituxan in this indication based on the trial findings. The combination was previously awarded breakthrough designation by the FDA so could enjoy a speedy ride through review.

Roche's Genentech unit is collaborating with the company on Venclexta's development and the two firms will co-market the drug in the US, with AbbVie selling it on its own outside the US.

"The analysis of the MURANO trial showed that Venclexta…in combination with Rituxan may offer another option for patients with relapsed/refractory CLL, potentially providing them with a chemotherapy-free therapy," said AbbVie's chief scientific officer Michael Severino.

AbbVie, which has said it expects to make $125m in sales with Venclexta this year, thinks MURANO is the key to unlocking the blockbuster sales potential for the drug. The company's chief executive Rick Gonzalez said recently that the trial "will significantly expand the market opportunity for this important therapy".

As it stands, Venclexta is currently approved for a subset of CLL patients with a specific type of mutation (17p deletion), but combining the drug with Rituxan as in MURANO would make it suitable for the broader relapse/refractory CLL patient population.

Previously, AbbVie has said it is eyeing sales of up to $2bn for Venclexta by 2020, while EvaluatePharma suggesting that is entirely achievable if it picks up additional indication and predicting sales of the drug would hit $1.5bn in the US alone by 2021, rising to almost $3bn globally the following year.

AbbVie and Roche have ambitions to extend the use of the drug into non-Hodgkin's lymphoma (NHL) and acute myeloid leukaemia (AML), picking up a breakthrough designation from the FDA this year for the drug as a combination treatment with low-dose chemotherapy in treatment-naïve AML patients who are ineligible for intensive induction chemo.

Meanwhile, AbbVie is also looking at combining Venclexta with its flagship cancer drug, BTK inhibitor Imbruvica (ibrutinib) for haematological cancer, which has already hit the blockbuster mark with sales topping $1.8bn last year in CLL, mantle cell lymphoma (MCL), Waldenström macroglobulinaemia and marginal zone lymphoma (MZL). AbbVie has said it is targeting $7bn in peak sales for Imbruvica.

Article by
Phil Taylor

19th September 2017

From: Regulatory



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