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
Trial | Setting | Design | Primary endpoint |
---|---|---|---|
Columvi (glofitamab) | |||
NP3017* | r/r DLBCL | Uncontrolled | ORR 56%, mDoR 18.4mth (backs accelerated approval) |
Starglo** | r/r DLBCL | Chemo combo, vs Rituxan + chemo | OS, toplined positive 15 Apr 2024 (readout delayed from H2 2023) |
Globryte | r/r mantle cell lymphoma | Vs Rituxan + Revlimid or bendamustine | PFS (trial ends Feb 2026) |
Skyglo | 1L DLBCL | Polivy + R-CHP combo, vs Polivy + R-CHP | PFS (trial ends Jun 2026) |
Lunsumio (mosunetuzumab) | |||
GO29781* | 3L+ follicular lymphoma | Uncontrolled | ORR 80%, mDoR 22.8mth (backs accelerated approval) |
Sunmo | r/r CD20+ve aggressive lymphoma | Polivy combo, vs Rituxan + chemo | PFS (readout expected 2023/4) |
Celestimo** | 2L+ follicular lymphoma | Revlimid combo, vs Rituxan + Revlimid | PFS (interim analysis 2024) |
Marsun^ | r/r marginal zone lymphoma | Revlimid combo, vs investigator’s choice | PFS (trial ends Sep 2027) |
Morninglyte^ | 1L follicular lymphoma | Revlimid combo, vs Rituxan + chemo | PFS (trial ends Nov 2028) |
NCI-2024-02361^ | 1L follicular lymphoma | Vs Rituxan | PFS (trial ends Mar 2032) |
Notes: *ph1/2 trial, all others are ph3; **possible confirmatory study; ^investigator-initiated trial. Source: OncologyPipeline.
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