Epkinly bucks the delay trend

While Regeneron's Ordspono and, to an extent, Roche's Lunsumio have struggled in follicular lymphoma, AbbVie/Genmab's rival anti-CD20 T-cell engager Epkinly has pleasantly surprised. Epkinly's latest success has been the positive readout of its phase 3 Epcore FL-1 study, now toplined for PFS, on the basis of which a US filing has been made. This now faces a 30 November PDUFA date. In follicular lymphoma Epkinly has, since June 2024, had accelerated approval for third-line or later use; Epcore FL-1 could back a second-line indication, as well as confirming the earlier green light. Epcore FL-1 tested Epkinly plus Rituxan and Revlimid, versus Rituxan/Revlimid alone, and topline data from the active cohort have yielded an ORR of 96%, and a highly impressive PFS hazard ratio of 0.21, though Genmab said full data were being held back for December's ASH conference. Remarkably, this trial was once not expected to read out until 2028, before the timeline was brought forward to 2026 in February; in the event even this has been blown out of the water. Meanwhile, readout of Lunsumio's corresponding Celestimo study has been delayed from 2023/4 to some time this year, while Ordspono is mired in complete response letters.

A battle of four anti-CD20 T-cell engagers

Notes: AA=accelerated approval; CRL=complete response letter. Source: OncologyPipeline.