AbbVie and Roche tout a positive PhIII combo study of Venclexta, Rituxan in CLL — ahead of FDA pitch

AbbVie and Roche are getting a boost out of the news that their combination of Venclexta and Rituxan met their primary endpoint on progression-free survival, beating out a combination of chemotherapy and Rituxan for treatment-resistant cases of chronic lymphocytic leukemia.

AbbVie says they’ll be hustling along the data — none of which was on display today — to regulators after picking up a breakthrough drug designation on the combo for CLL, which has attracted a number of drugs.

Michael Severino

The results from the MURANO study have been awaited by a couple of the analysts covering AbbVie to see how the company can fare this year in expanding its prospects in oncology. Its big cancer drug driver is Imbruvica, with Humira providing the bulk of its revenue.

Leerink’s Geoffrey Porges counts himself as a happy camper on the news. He noted:

 We anticipate an expedited regulatory filing and approval based on these data, which will expand the labeled indication for Venclexta from a narrow subset of CLL patients (17p deletion) to the broader R/R CLL population and will accelerate the Venclexta revenue opportunity by H2 2018. Venclexta’s current quarterly revenue run rate of $20-30mm (our estimate) should increase significantly with the label expansion that is likely to follow this result.

Expanding the number of FDA OKs for this drug is crucial to AbbVie’s plan to expand revenue from about $125 million this year to as much as $1.5 billion to $2 billion a year by the end of the decade. The drug was originally approved for patients with CLL with 17p deletion back in April of 2016.

Researchers are also staying mum about the safety results from the study, saying they’re examining adverse events registered in the study.

CLL accounts for about a quarter of all the new leukemia cases diagnosed every year.

“AbbVie is committed to researching the full potential of Venclexta both as monotherapy and combination therapy in patients with CLL and other hematologic malignancies. The analysis of the MURANO trial showed that Venclexta in combination with Rituxan may offer another option for patients with R/R CLL, potentially providing them with a chemotherapy-free therapy,” said Michael Severino, AbbVie’s chief scientific officer. “We are looking forward to working with regulatory authorities around the world to bring this additional treatment regimen to R/R CLL patients.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Flatiron Health New York City or San Francisco

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