Armed with new data, AbbVie, Roche likely to file early for bigger Venclexta use in CLL: analyst

Venclexta
AbbVie and Roche partnered up on Venclexta, approved in 2016 for CLL with a 17p deletion, and now they're eyeing a leap into a broader market.

AbbVie and Roche have pinned big blockbuster hopes on Venclexta, their targeted blood cancer drug that’s approved for a rare form of leukemia. That kind of growth means expanding the drug’s list of indications, and it just took another step toward a big one.

A closely watched study, Murano, was stopped early Monday, after an interim analysis positive enough to open up Venclexta treatment to patients in the control arm. The trial evaluated Venclexta paired with Roche’s Rituxan against Rituxan plus a standard therapy, bendamustine.

The companies said the Venclexta combo had hit its primary goal—staving off cancer progression better than the Rituxan/bendamustine pairing—with details forthcoming at a future conference. And analysts figure the data will soon be submitted to the FDA for a new Venclexta approval.

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That’s because Murano focused on a much bigger group of patients than the drug is currently approved to treat: chronic lymphocytic leukemia (CLL) associated with a mutation called the 17p deletion. The new trial enrolled CLL patients with or without that mutation, who had either relapsed after at least one round of chemo-containing therapy or failed to respond to prior regimens.

“We anticipate an expedited regulatory filing and approval based on these data, which will expand the labeled indication for Venclexta ... and will accelerate the Venclexta revenue opportunity” by the second half of next year, Leerink analyst Geoffrey Porges said in a Monday note. Venclexta has so far been selling at a rate of $20 million to $30 million per quarter, he said.

With the help of this new use, Venclexta is expected to hit $1.5 billion to $2 billion in sales by the end of the decade. EvaluatePharma early this year predicted the drug would grow to $3 billion by 2022, putting it among the top-selling cancer meds that year.

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Venclexta hit the market last year at a list price of $110,000, and it faces competition from Celgene’s megablockbuster Revlimid as well as newer entrants like Gilead Sciences’ Zydelig. AbbVie itself sells Imbruvica for CLL patients, including those new to treatment and those who’ve relapsed or are treatment-resistant.

But Porges sees Venclexta as a partner to Imbruvica: Patients are likely to develop resistance to Imbruvica and need to move on to a new treatment that works differently, he says. And as a first-in-class BCL-2 inhibitor, Venclexta is certainly that.

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Venclexta is important to Roche and AbbVie both; they need to build up their portfolios ahead of biosimilar competition for their biggest meds. Roche expects Rituxan biosims by the end of 2017 in some countries and in the U.S. after 2019, putting $7 billion in sales at risk. Meanwhile, Herceptin knockoffs have already hit overseas, though one from Biocon and Mylan has snagged in Europe. The FDA accepted approval apps for two in the U.S. And just last week, an Avastin biosim from Amgen and Allergan nabbed an FDA nod.

Roche has several follow-up drugs already on the market, though. Some analysts figure AbbVie’s best-seller, the $16 billion Humira, could see a major sales drop off fairly quickly. AbbVie's next-best seller is actually Imbruvica, with 1.8 billion in 2016 sales, its share of the med, which it markets in partnership with Johnson & Johnson.