Table 1.
Demographics and baseline disease characteristics.
| BGB-3111–214 (MAGNOLIA study) | |
|---|---|
| Characteristics | R/R MZL (N = 68) |
| Age, years | |
| Median (range) | 70 (37–95) |
| Age category, n (%) | |
| ≥65 years and <75 years | 22 (32.4) |
| ≥75 years | 19 (27.9) |
| Sex, n (%) | |
| Male | 36 (52.9) |
| Female | 32 (47.1) |
| Baseline ECOG PS score, n (%) | |
| 0 | 39 (57.4) |
| 1 | 24 (35.3) |
| 2 | 5 (7.4) |
| Bulky disease, n (%) | |
| LDi >5 cm | 25 (36.8) |
| Bone marrow involvement, n (%)a | 29 (42.6) |
| Extranodal disease, n (%)b | 53 (77.9) |
| Refractory diseasec | 22 (32.4) |
| Evidence of FDG-avid disease by IRC, n (%) | |
| FDG-avid | 61 (89.7) |
| Non–FDG-avid | 7 (10.3) |
| MZL subtype, n (%) | |
| Extranodal (MALT) | 26 (38.2) |
| Nodal | 26 (38.2) |
| Splenic | 12 (17.6) |
| Unknownd | 4 (5.9) |
| Site of disease for MALT subtype, n (%) | |
| Gastric | 2 (7.7) |
| Cutaneous | 4 (15.4) |
| Nongastric/noncutaneous | 19 (73.1) |
| Unknown | 1 (3.8) |
| Baseline cytopeniae | 20 (29.4) |
| LDH (U/L) | |
| Median (range) | 204 (128.5–1,405) |
| LDH, n (%) | |
| Above normal | 16 (23.5) |
| Number of previous therapies | |
| Median (range) | 2 (1–6) |
| Time from end of last therapy to study entry (months) | |
| Median (range) | 20.6 (1–176.6) |
| Previous therapyf, n (%) | |
| Rituximab-based chemotherapy | 60 (88.2) |
| R-CVP | 25 (36.8) |
| BR | 22 (32.4) |
| R-CHOP | 17 (25.0) |
| Rituximab monotherapy | 15 (22.1)g |
| Rituximab + lenalidomide | 2 (2.9) |
| Radiation therapy | 15 (22.1) |
| Splenectomy | 7 (10.3) |
| Autologous hematopoietic stem cell transplant | 4 (5.9) |
Abbreviations: BR, bendamustine/rituximab; LDi, longest diameter; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CVP, rituximab plus cyclophosphamide, vincristine sulfate, and prednisone.
aDerived from baseline bone marrow biopsy/aspiration per investigator assessment.
bExtranodal disease is defined as patients with extranodal baseline target or nontarget lesions, or bone marrow involvement, as per investigator assessment.
cRefractory disease is defined as best overall response of stable disease or PD from last prior anticancer regimen.
dFour patients presented with both nodal and extranodal lesions; investigators were unable to classify the primary MZL subtype.
eCytopenia is defined as baseline neutrophils ≤1.5 × 109/L or baseline platelet ≤100 × 109/L or baseline hemoglobin ≤110 g/L.
fCategories are not mutually exclusive. A patient could have been included under multiple regimens.
gOf the 15 patients who received prior rituximab monotherapy, rituximab was the only prior treatment in 7 patients.