Genmab: epcoritamab succeeds in frontline DLBCL
The Phase 3 EPCORE DLBCL-2 trial of epcoritamab plus R-CHOP met its primary endpoint in newly diagnosed diffuse large B-cell lymphoma, cutting the risk of progression or death by 51% (HR 0.49, p<0.0001). It is the first positive Phase 3 for a bispecific combination in this setting. Genmab and AbbVie will now talk to regulators; overall survival has not yet been reported.
Switzerland
Idorsia: new aprocitentan data heading to AHA Hypertension
Idorsia will present new analyses of the Phase 3 PRECISION trial at the AHA Hypertension sessions on 10 October, focused on obese and cardiovascular-kidney-metabolic patients: 69% of trial patients were obese and 54% diabetic. The data support positioning the drug in resistant hypertension with metabolic disease.
Alentis: CSL deal worth up to $1.6bn
CSL will co-develop lixudebart, Alentis’ anti-claudin-1 antibody, in ANCA-associated vasculitis with kidney involvement. The Basel company gets $355m upfront and up to $1.2bn in milestones, and keeps 45% of global profits; CSL funds the rest of Phase 2 and the planned Phase 3.
Rest of Europe
Alvotech: FDA doubles Simlandi capacity
The FDA approved a second drug-substance suite in Reykjavik for Simlandi, Alvotech’s Humira biosimilar, doubling its capacity for the US market. The site’s July inspection closed as “VAI”, which clears the way for FDA decisions on four pending biosimilars: golimumab, aflibercept, denosumab and vedolizumab.
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