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#ASH17: Roche unveils stellar PhII DLBCL data for one of its top hematology drugs in the pipeline

One of Genentech’s top experimental hematology drugs has delivered outstanding results in a mid-stage study for aggressive cases of diffuse large B-cell lymphoma, a field that has been overshadowed by the two approved CAR-Ts in the field.

Sandra Horning

Newly rewarded a breakthrough therapy designation from the FDA — and a similar status from the EMA — investigators say they tracked a complete response rate of 40% in the Phase II trial. The drug — polatuzumab vedotin — was added to bendamustine and Rituxan (BR), a combo that provided a 15% CR rate in the control arm that was clearly overshadowed by the triplet.

The study also gathered promising overall survival rates, with the triplet group achieving a median OS of 11.8 months compared to 4.7 months in the control group.

Promising Phase II data with a BTD qualifies for a quick review at the FDA, and Roche CMO Sandra Horning says they’re headed to regulators to discuss the path forward.

The drug — which uses ADC tech from Seattle Genetics — is a first-in-class anti-CD79b antibody drug conjugate which targets a protein prominent in B-cell non-Hodgkin lymphoma, and Genentech is following up with a range of studies involving combos with its top cancer therapies.

Roche needs all the help it can get in cancer right now, with generics eating away at its top 3 franchise therapies.

“As many as 40 percent of people with diffuse large B-cell lymphoma do not respond to initial therapy or experience the return of their disease, at which point their treatment options are limited and the prognosis is very poor,” said Horning.


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