Selected phase 2 and phase 3 ongoing studies in untreated or relapsed or refractory MZL
| Compound . | Class . | Setting . | Phase . | N pts . | Primary end point . | Comparator . | ClinicalTrials.gov N (Title) . |
|---|---|---|---|---|---|---|---|
| Ibrutinib-rituximab | BTKi + anti-CD20 | EMZL first-line | 2 | 130 | CR, PFS | / | NCT03697512 (MALIBU, IELSG47 |
| Ibrutinib-rituximab | BTKi + anti-CD20 | EMZL, NMZL, SMZL first-line | 3 | 138 | CR | Placebo-rituximab | NCT04212013 |
| Copanlisib-rituximab | PI3Ki(αδ) + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03474744 (COUP-1) |
| Obinutuzumab | Anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03322865 (OLYMP-1) |
| Pembrolizumab-rituximab | Anti-PD-1 + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03474744 (POLE-1) |
| Venetoclax-rituximab | BCL2i + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 47 | CR | / | NCT04416451 |
| Mosunetuzumab-lenalidomide | Bispecific (CD3 × CD20) + IMID | FL, EMZL, NMZL, SMZL first-line | 2 | 52 | CR | / | NCT04792502 (BrUOG 401) |
| Mosunetuzumab-polatuzumab vedotin-obinutuzumab | Bispecific (CD3 × CD20) + anti-CD79b + anti-CD20 | FL, EMZL, NMZL, SMZL first-line | 2 | 42 | CR | / | NCT05169658 |
| Ibrutinib-rituximab-lenalidomide | BTKi + anti-CD20 + IMID | FL, EMZL, NMZL, SMZL first-line | 2 | 46 | CR | / | NCT02532257 |
| Acalabrutinib-tafasitamab | BTKi + anti-CD19 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 24 | CR | / | NCT04646395 (IELSG49) |
| Zanubrutinib-rituximab | BTKi + anti-CD20 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 372 | PFS | R-lenalidomide | NCT05100862 |
| Orelabrutinib | BTKi | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 80 | ORR | / | NCT03797456 |
| Zandelisib | PI3Kiδ | EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 180 | ORR | / | NCT03768505 (TIDAL) |
| Zandelisib-rituximab | PI3Kiδ + anti-CD20 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 534 | PFS | BR or R-CHOP | NCT04745832 (COASTAL) |
| SHC014748M | PI3Kiδ | FL, EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 122 | ORR | / | NCT04431089 |
| HMPL-689 | PI3Kiδ | FL, EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 81 (MZL) | ORR | / | NCT04849351 |
| Loncastuximab tesirine | Anti-CD19 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 50 | CR | / | NCT05296070 |
| Lisocabtagene maraleucel | CAR T CD19 | FL, MZL R/R (≥2 prior lines) | 2 | 188 | ORR, CR | / | NCT04245839) (TRANSCEND FL) |
| Epcoritamab | Bispecific (CD3 × CD20) | MZL R/R (≥2 prior lines) | 2a (expansion cohort) | 30 | ORR | / | NCT03625037 (GCT3013-01) |
| Tafasitamab-rituximab-lenalidomide | Anti-CD19 + anti-CD20 + IMID | FL, EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 618 | PFS | Placebo-R-lenalidomide | NCT04680052 (InMIND) |
| Compound . | Class . | Setting . | Phase . | N pts . | Primary end point . | Comparator . | ClinicalTrials.gov N (Title) . |
|---|---|---|---|---|---|---|---|
| Ibrutinib-rituximab | BTKi + anti-CD20 | EMZL first-line | 2 | 130 | CR, PFS | / | NCT03697512 (MALIBU, IELSG47 |
| Ibrutinib-rituximab | BTKi + anti-CD20 | EMZL, NMZL, SMZL first-line | 3 | 138 | CR | Placebo-rituximab | NCT04212013 |
| Copanlisib-rituximab | PI3Ki(αδ) + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03474744 (COUP-1) |
| Obinutuzumab | Anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03322865 (OLYMP-1) |
| Pembrolizumab-rituximab | Anti-PD-1 + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 56 | CR | / | NCT03474744 (POLE-1) |
| Venetoclax-rituximab | BCL2i + anti-CD20 | EMZL, NMZL, SMZL first-line | 2 | 47 | CR | / | NCT04416451 |
| Mosunetuzumab-lenalidomide | Bispecific (CD3 × CD20) + IMID | FL, EMZL, NMZL, SMZL first-line | 2 | 52 | CR | / | NCT04792502 (BrUOG 401) |
| Mosunetuzumab-polatuzumab vedotin-obinutuzumab | Bispecific (CD3 × CD20) + anti-CD79b + anti-CD20 | FL, EMZL, NMZL, SMZL first-line | 2 | 42 | CR | / | NCT05169658 |
| Ibrutinib-rituximab-lenalidomide | BTKi + anti-CD20 + IMID | FL, EMZL, NMZL, SMZL first-line | 2 | 46 | CR | / | NCT02532257 |
| Acalabrutinib-tafasitamab | BTKi + anti-CD19 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 24 | CR | / | NCT04646395 (IELSG49) |
| Zanubrutinib-rituximab | BTKi + anti-CD20 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 372 | PFS | R-lenalidomide | NCT05100862 |
| Orelabrutinib | BTKi | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 80 | ORR | / | NCT03797456 |
| Zandelisib | PI3Kiδ | EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 180 | ORR | / | NCT03768505 (TIDAL) |
| Zandelisib-rituximab | PI3Kiδ + anti-CD20 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 534 | PFS | BR or R-CHOP | NCT04745832 (COASTAL) |
| SHC014748M | PI3Kiδ | FL, EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 122 | ORR | / | NCT04431089 |
| HMPL-689 | PI3Kiδ | FL, EMZL, NMZL, SMZL R/R (≥2 prior lines) | 2 | 81 (MZL) | ORR | / | NCT04849351 |
| Loncastuximab tesirine | Anti-CD19 | EMZL, NMZL, SMZL R/R (≥1 prior line) | 2 | 50 | CR | / | NCT05296070 |
| Lisocabtagene maraleucel | CAR T CD19 | FL, MZL R/R (≥2 prior lines) | 2 | 188 | ORR, CR | / | NCT04245839) (TRANSCEND FL) |
| Epcoritamab | Bispecific (CD3 × CD20) | MZL R/R (≥2 prior lines) | 2a (expansion cohort) | 30 | ORR | / | NCT03625037 (GCT3013-01) |
| Tafasitamab-rituximab-lenalidomide | Anti-CD19 + anti-CD20 + IMID | FL, EMZL, NMZL, SMZL R/R (≥1 prior line) | 3 | 618 | PFS | Placebo-R-lenalidomide | NCT04680052 (InMIND) |
BCL2i, BCL2 inhibitor; CR, complete response rate; IMID: immunomodulatory drug; NA, not available; PD-1, programmed cell death 1 protein; PI3Ki, phosphatidylinositol 3-kinase inhibitor; R, rituximab; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone.