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Roche, AbbVie hit by clinical hold for Venclexta in myeloma

Safety concerns could hit blockbuster expectations

Venclexta

AbbVie and Roche have been forced to halt recruitment of patients into all clinical trials of Venclexta in multiple myeloma after the FDA slapped a partial clinical hold on the programme.

The regulator is concerned about what appears to be a higher death rate in patients taking the drug compared to those on control, and wants to take a good look at the data before exposing any new subjects to drug treatment. Patients already on the drug in myeloma trials can however continue to receive the drug.

It’s a big worry for AbbVie and Roche, which have blockbuster aspirations for Venclexta (venetoclax) that are tied in no small part to its potential in multiple myeloma.

The partial clinical hold follows a review of data from the ongoing phase 3 BELLINI trial (M14-031) of the drug in relapsed/refractory multiple myeloma, according to the companies, who say they “remain confident in the benefit/risk profile of venetoclax in [its] approved indications.”

The trial was due to generate preliminary results in the first half of this year, and for now it is unclear whether AbbVie and Roche will be able to stick to that schedule given the recruitment hold.

The drug has been approved for chronic lymphocytic leukaemia (CLL) since 2016 and picked up a second indication in acute myeloid leukaemia (AML) last year, but analyst Steve Scala at Cowen & Co said earlier this month that BELLINI is “one of the most exciting…readouts” for the drug in 2019.

AbbVie and Roche certainly have high sales expectations for venetoclax, which is sold as Venclyxto outside the US, and have been steadily extending the drug’s uses as it heads towards blockbuster sales. An approval in first-line CLL should help accelerate growth, and AbbVie has said it expects sales to reach $725m this year.

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AbbVie's Michael Severino

“We are committed to patient safety and are thoroughly analysing the results observed in the BELLINI trial,” said Michael Severino, AbbVie’s vice chairman and president.

“We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma programme,” he added.

In myeloma, they are adopting a two-pronged strategy, according to Severino. The first involves going after a broad, unselected patient population in relapsed/refractory patients, which is the group enrolled in BELLINI, and the second will zero in on myeloma patients with a specific biomarker that in early trials seem to be strong responders to venetoclax.

The latter approach could be particularly important as a differentiator, as myeloma is becoming an increasingly crowded category, said Severino. Both approaches will of course be undermined if the excess mortality in BELLINI leads to a protracted clinical hold.

19th March 2019

From: Regulatory

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