Roche enters phase 3 in first-line lymphoma with Columvi

Roche's new phase 3 trial adds Columvi, a CD20-targeted T-cell engager, on top of the approved Polarix regimen of Polivy plus R-CHP. The open-label study, to start before the end of the month, will enrol 1,130 patients with previously untreated CD20-positive large B-cell lymphoma, with PFS versus the Polarix regimen alone as its primary endpoint. Preliminary phase 1 data from the NP40126 trial presented at this year's ASCO showed Columvi to yield an ORR of 100% and three grade 1 cytokine release events. AbbVie's/Genmab's epcoritamab was the first CD20xCD3 bispecific to enter phase 3 in this setting, with recruitment initiated in February in the EPCORE-DLBCL-2 trial. Regeneron's odronextamab is lagging behind: filings in the EU in relapsed follicular lymphoma and diffuse large B-cell lymphoma were accepted by the EMA in August, and although Regeneron has already disclosed a broad phase 3 programme, consisting of five trials, none of these have started yet. Regeneron's latest update from August indicates that the confirmatory Olympia programme is expected to start before the end of 2023.