AbbVie and Genmab’s Epkinly might have recently lost ground to Roche’s rival CD20 T-cell engager Columvi, but the partners are making good on their promise to start several phase 3 trials this year. The Epcore DLBCL-4 trial, recently posted on clinicaltrials.gov, will test Epkinly plus Revlimid in relapsed/refractory DLBCL patients who have failed or are ineligible for autologous stem cell transplant. Genmab previously disclosed plans for two more pivotal studies this year, including one in transplant-eligible patients. Epkinly is already in the confirmatory Epcore DLBCL-1 trial in second-line DLBCL, but that’s testing monotherapy; readout of that study has been delayed from 2023 until late this year. Meanwhile, Columvi looks on the way to full approval following impressive results from the Starglo study. Both drugs received accelerated approval last year for third-line or later DLBCL. Epkinly also recently got the go-ahead in relapsed/refractory follicular lymphoma; here, Roche’s focus is on its other CD20 product, Lunsumio, which curiously is also in a pivotal trial in more aggressive forms of non-Hodgkin’s lymphoma. Lagging behind is Regeneron, whose odronextamab was knocked back by the FDA in late-line DLBCL and FL in March. Phase 3 trials of CD20 T-cell engagers in DLBCLTrialSettingRegimenReadoutEpkinly (AbbVie/Genmab)Epcore DLBCL-1 (confirmatory)r/r DLBCLMonotherapy, vs investigator's choice chemoExpected end 2024 (delayed from 2023)Epcore DLBCL-21L DLBCL+ R-CHOP, vs R-CHOPCompletes Jan 2025Epcore DLBCL-4r/r DLBCL+ Revlimid, vs Rituxan + gemcitabine + oxaliplatinCompletes Nov 2027Columvi (Roche)Starglor/r DLBCL+ gemcitabine + oxaliplatin, vs Rituxan + gemcitabine + oxaliplatinData presented at EHA 2024Skyglo1L DLBCL+ Pola-R-CHP, vs Pola-R-CHPCompletes Jun 2026Lunsumio (Roche)Sunmor/r aggressive B-cell NHL+ Polivy, vs Rituxan + gemcitabine + oxaliplatinCompletes May 2025Odronextamab (Regeneron)Olympia-31L DLBCL+ CHOP, vs Rituxan + CHOPCompletes Dec 2028Olympia-4r/r aggressive B-cell NHLMonotherapy, vs SoCCompletes Jul 2027Source: OncologyPipeline.
AbbVie and Genmab’s Epkinly might have recently lost ground to Roche’s rival CD20 T-cell engager Columvi, but the partners are making good on their promise to start several phase 3 trials this year. The Epcore DLBCL-4 trial, recently posted on clinicaltrials.gov, will test Epkinly plus Revlimid in relapsed/refractory DLBCL patients who have failed or are ineligible for autologous stem cell transplant. Genmab previously disclosed plans for two more pivotal studies this year, including one in transplant-eligible patients. Epkinly is already in the confirmatory Epcore DLBCL-1 trial in second-line DLBCL, but that’s testing monotherapy; readout of that study has been delayed from 2023 until late this year. Meanwhile, Columvi looks on the way to full approval following impressive results from the Starglo study. Both drugs received accelerated approval last year for third-line or later DLBCL. Epkinly also recently got the go-ahead in relapsed/refractory follicular lymphoma; here, Roche’s focus is on its other CD20 product, Lunsumio, which curiously is also in a pivotal trial in more aggressive forms of non-Hodgkin’s lymphoma. Lagging behind is Regeneron, whose odronextamab was knocked back by the FDA in late-line DLBCL and FL in March.
Phase 3 trials of CD20 T-cell engagers in DLBCL
| Trial | Setting | Regimen | Readout |
|---|
| Epkinly (AbbVie/Genmab) |
| Epcore DLBCL-1 (confirmatory) | r/r DLBCL | Monotherapy, vs investigator's choice chemo | Expected end 2024 (delayed from 2023) |
| Epcore DLBCL-2 | 1L DLBCL | + R-CHOP, vs R-CHOP | Completes Jan 2025 |
| Epcore DLBCL-4 | r/r DLBCL | + Revlimid, vs Rituxan + gemcitabine + oxaliplatin | Completes Nov 2027 |
| Columvi (Roche) |
| Starglo | r/r DLBCL | + gemcitabine + oxaliplatin, vs Rituxan + gemcitabine + oxaliplatin | Data presented at EHA 2024 |
| Skyglo | 1L DLBCL | + Pola-R-CHP, vs Pola-R-CHP | Completes Jun 2026 |
| Lunsumio (Roche) |
| Sunmo | r/r aggressive B-cell NHL | + Polivy, vs Rituxan + gemcitabine + oxaliplatin | Completes May 2025 |
| Odronextamab (Regeneron) |
| Olympia-3 | 1L DLBCL | + CHOP, vs Rituxan + CHOP | Completes Dec 2028 |
| Olympia-4 | r/r aggressive B-cell NHL | Monotherapy, vs SoC | Completes Jul 2027 |
