Zain Ebrahim

Zain Ebrahim sought clarification on the events tracking for the Epkinly first-line DLBCL trial, given the 2026 readout reiteration. He also asked about discussions with the FDA regarding the petosemtamab Phase 3 trial design and confidence in objective response rate (ORR) as a sufficient regulatory endpoint.

Answer

CMO Tahamtan Ahmadi stated that the company does not typically provide commentary on events tracking during calls. Chief Development Officer Judith Klimovsky confirmed that the two petosemtamab Phase 3 studies have dual endpoints of ORR and OS. She noted that using ORR as a surrogate endpoint, potentially associated with overall survival, is standard in areas of unmet medical need, and the company is comfortable with the current design and endpoints.

Zain Ebrahim asked for clarification on EPKINLY's first-line DLBCL trial events tracking relative to expectations and Genmab's confidence in objective response rate (ORR) as a sufficient regulatory endpoint for petosemtamab Phase III trials after the Merus acquisition.

Answer

CEO Jan van de Winkel, CMO Tahamtan Ahmadi, and Chief Development Officer Judith Klimovsky addressed the questions. Ahmadi declined to comment on specific events tracking for the EPKINLY first-line DLBCL trial, only stating that they do track them. Klimovsky confirmed that petosemtamab's two Phase III studies have dual endpoints of ORR and OS, which is standard for areas of unmet medical need where earlier endpoints can be surrogates for OS. She expressed satisfaction with the design and the dual endpoint, noting that the Origami 5 study also used ORR and PFS.