Table 2.
Comparison of outcomes with approved monotherapies in MCL
| Study type | Therapy | Dose | N | Median OS (months) | Median PFS (months) | ORR (%) | CR/CRu (%) | PR (%) |
|---|---|---|---|---|---|---|---|---|
| Phase II29 | Bortezomib | 1.3 mg/m2, days 1, 4, 8, 11, every 21 days | 155 | 23.5 | 6.5 | 32 | 8 | 24 |
| Phase II30 | Lenalidomide | 25 mg/day PO on days 1–21 of a 28-day cycle | 134 | 19 | 4 | 28 | 8 | 20 |
| Phase II27 | Ibrutinib | 560 mg/day | 111 | NR, 58% at 18 m | 14 | 68 | 21 | 47 |
| Phase III31 | Temsirolimus | 175 mg weekly for 3 weeks followed by 75 mg weekly | 54 | 13 | 5 | 22 | 2 | 20 |
| 175 mg weekly for 3 weeks followed by 25 mg weekly | 54 | 10 | 3 | 6 | 0 | 6 |
Abbreviations: CR, complete response; CRu, complete response unconfirmed; m, months; N, evaluable patients; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression free survival; PO, per oral; PR, partial response.