Regeneron’s double-whammy, courtesy of Roche

Roche appears to have done enough to secure full US approval of Columvi in relapsed/refractory aggressive lymphoma after its phase 3 Starglo trial was toplined positive for overall survival this morning. Columvi secured accelerated approval in this setting last June, and Starglo is a potentially confirmatory study. What this means for Regeneron’s rival anti-CD20 T-cell engager odronextamab is less clear, however. Odronextamab’s own accelerated approval filing in relapsed/refractory DLBCL was hit with a US complete response letter last month, and once Columvi secures a full green light the FDA might be reluctant to hand accelerated approval to a similarly acting drug for the same use. Whether Columvi’s full approval is imminent will depend on the quality of the Starglo data; the 270-patient study’s readout was delayed from the second half of 2023, and Roche has said nothing about whether the OS result was clinically meaningful. Moreover, there are numerous moving parts in DLBCL, including the shift of autologous Car-T therapy from relapsed to the second-line setting, Polivy’s recent front-line full approval (despite the Polarix trial showing no OS benefit), and the availability on an accelerated basis of another anti-CD20 T-cell engager, Genmab/AbbVie’s Epkinly.

Key studies of Roche's anti-CD20 T-cell engagers

Notes: *ph1/2 trial, all others are ph3; **possible confirmatory study; ^investigator-initiated trial. Source: OncologyPipeline.