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#ASH17: AbbVie, Roche boast stellar PhIII leukemia data for a “breakthrough” combo with blockbuster ambitions

AbbVie and Roche rolled out the full battery of impressivePhase III data for their combination of Venclexta and Rituxan, making a case at ASH that they’ve nailed down all the data needed to prove it should be used for second line cases of chronic lymphocytic leukemia.

And the sooner the better.

Michael Severino

Their matchup handily beat out the standard CLL combo of bendamustine and Rituxan on both progression-free survival as well as complete responses. The 24-month PFS rate hit 84.9% for the AbbVie $ABBV/Roche $RHHBY combo against 36.3% for chemo/Rituxan. And the complete response rate — no sign of the disease — registered at 26.8% against 8.2%.

The hazard ratio was 0.17. The median PFS rate had not been hit yet when the review committee opted to unblind the results.

That all fits with Geoffrey Porges’ theory that the combo is on a short path to breaking out of a small, biomarker defined set of patients for the full second-line setting. (Further down the road the pharma partners hope to add frontline approval for CLL.) Leerink’s Porges is looking for a 2018 OK and $690 million in 2019 sales, with Evaluate pegging consensus peak estimates at around $3 billion.

This is all good news for AbbVie, which is in the business of building new franchise therapeutics that can eventually withstand generic competition in the US to Humira — though that appears to still be a few years away. Roche has more immediate issues with generics that will be helped by its partnership with AbbVie.

“The data from the MURANO trial represents the next evolution in a potential treatment option for patients with relapsed/refractory CLL, an indication for which we received Breakthrough Therapy Designation,” said Michael Severino, executive vice president, research and development, and chief scientific officer, AbbVie. “We are proud to present these findings at the ASH annual meeting and are working closely with regulatory authorities to bring this combination therapy to appropriate patients as soon as possible.”


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