Table 2.
Ongoing phase 3 clinical trials with BsAbs in frontline FL
| Clinical trial | N | Description | Patients | Primary end point(s) | Start date/anticipated primary end point date |
|---|---|---|---|---|---|
| BsAbs in GELF+ patients | |||||
| MorningLyte | 790 | Mosun + Len vs R or O + CHOP or B | Grade 1-3A, FLIPI 2-5 | PFS | May 2024/November 2028 |
| EPCORE FL-2 | 1080 | 4-way randomization with main comparison between arm A (Epco + Len + R) and arm B (investigator’s choice of R or O + chemotherapy [CHOP or B]) Arm A1: shorter course Epco + Len + R Arm C: Len + R |
Stage II-IV, Grade 1-3A | CR30, PFS | February 2024/October 2028 |
| OLYMPIA-1 | 478 | Odro followed by Odro maintenance vs CIT (R-CVP, R-CHOP, or BR, all followed by R maintenance) |
Stage III-IV or stage II bulky, Grade 1-3A | CR30 | December 2023/April 2029 |
| OLYMPIA-2 | 733 | 1:1:1 randomization to R chemotherapy (CVP or CHOP) with R maintenance vs Odro chemotherapy (CVP or CHOP) vs Odro chemotherapy + Odro maintenance |
Stage III-IV or stage II bulky, Grade 1-3A | CR30 | November 2023/July 2029 |
| SOUNDTRACK-F1 | 1015 | 1:1:1 randomization: arms A and B (different schedules of AZD0486 + R) vs arm C (R-CVP, R-CHOP, or BR followed by R maintenance) |
Grade 1-3A | PFS | August 2024/April 2031 |
| BsAb in GELF− patients | |||||
| SWOG2308 | 600 | 4 weekly doses of R followed by 5 doses every 8 weeks vs 8 cycles of Mosun |
Grade 1-3A, low GELF | PFS | August 2024/March 2032 |
B, bendamustine; Epco, epcoritamab; Len, lenalidomide; Mosun, mosunetuzumab; O, obinutuzumab; Odro, odronextamab; R, rituximab.