#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.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 41,800+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Head of Business Development
Wren Therapeutics Boston, MA
Life Sciences Venture Professional
Northpond Ventures Washington, DC
Senior Drug Discovery Oncologist
Schrödinger New York, NY

Visit Endpoints Careers ->