Results

#ASH17: Late breaker from AbbVie, Roche highlights a blockbuster breakout opportunity for Venclexta in CLL

When AbbVie $ABBV and Roche $RHHBY won approval for Venclexta (venetoclax) back in the spring of 2016 as a new treatment for chronic lymphocytic leukemia, the pharma giants had some big revenue numbers in mind. And with some new data that’s coming out at ASH in a couple of weeks, they may well be on their way to achieving that.

In a late breaker abstract posted on Tuesday, researchers broke down the numbers from the MURANO study on a combination of Venclexta — which targets B-cell lymphoma 2 (BCL-2) protein — and Rituxan against a patient group getting Rituxan and Treanda. They highlighted a trend in their favor on progression-free survival, which isn’t complete, with a 93.3% overall response rate and an impressive 26.8% complete response rate — no visible sign of the disease — in the Venclexta arm compared to only 8.2% in the control arm. The ORR in the control arm was 67.7%.

The bottom line from investigators:

The primary analysis of MURANO, the first Phase III study of V in R/R CLL, shows a profound improvement in PFS vs standard BR chemoimmunotherapy, with consistent effects in all-risk subsets. Key secondary endpoints, including OS, ORR and CR rate, also showed consistent improvements with remarkable rates of peripheral blood MRD– that exceed those previously attained in treatment of R/R CLL.

Why is that important? The drug was given one of the FDA’s increasingly common accelerated approvals for a narrow genetic subset of CLL patients with a 17p deletion, opening up a small market now worth around $30 million a quarter, according to Leerink’s Geoffrey Porges. Opening the full CLL market of treatment-resistant patients will put it on a track to hit $922 million in 2021, with consensus at $1.2 billion. EvaluatePharma has pegged the peak sales estimate at up to $3 billion.


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