POLARIX was a double-blind, randomized, multicenter, phase 3 study of 879 patients1
Key Exclusion Criteria: Patients with a history of indolent lymphoma, a contraindication to any component of R-CHOP, previous receipt of anthracycline agents, and known CNS involvement
Stratification factors: IPI score (2 vs 3-5), Bulky disease (≥7.5cm vs absence), Geographic region§
IIPFS was calculated in a time-to-event analysis, in which investigator-assessed disease progression or relapse or death from any cause were counted as events.
POLIVY (1.8 mg/kg) or vincristine (1.4 mg/m2), along with rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), and doxorubicin (50 mg/m2) was administered by IV infusion on Day 1 of Cycles 1-6. All patients received oral prednisone 100 mg once daily on Days 1-5 of each of the first 6 cycles. Rituximab monotherapy (375 mg/m2) was administered on Day 1 of Cycles 7 and 8. Each cycle was 21 days.1
*Recommended dose of POLIVY is 1.8 mg/kg IV + R-CHP every 21 days for 6 cycles.
†In lieu of vincristine.
‡In lieu of POLIVY.
§Western Europe, United States, Canada and Australia vs Asia vs Rest of World.
¶Defined as time from randomization to the earliest occurrence of disease progression or relapse, death, an efficacy finding that led to non-protocol specified lymphoma treatment, or biopsy positive for residual disease.
#Based on PET-CT and determined by BICR.
POLIVY + R-CHP (n=440) | R-CHOP (n=439) | |||
---|---|---|---|---|
Age | >60 years, n (%) | 300 (68.2) | 308 (70.2) | |
Median (range) | 65.0 (19-80) | 66.0 (19-80) | ||
Sex, n (%) | Male | 239 (54.3) | 234 (53.3) | |
Female | 201 (45.7) | 205 (46.7) | ||
Geographic region, n (%)* | W. Europe, USA, CAN, AUS | 302 (68.6) | 301 (68.6) | |
Asia | 81 (18.4) | 79 (18.0) | ||
Rest of world | 57 (13.0) | 59 (13.4) | ||
ECOG PS, n (%)† | 0-1 | 374 (85.0) | 363 (82.7) | |
2 | 66 (15.0) | 75 (17.1) | ||
Bulky disease, n (%)*,‡ | 193 (43.9) | 192 (43.7) | ||
Ann Arbor stage, n (%)§ | I-II | 47 (10.7) | 52 (11.8) | |
III-IV | 393 (89.3) | 387 (88.2) | ||
IPI score, n (%)* | 2 | 167 (38.0) | 167 (38.0) | |
3-5 | 273 (62.0) | 272 (62.0) | ||
Histologic diagnosis, n (%) | DLBCL NOS (including GCB and ABC) | 373 (84.8) | 367 (83.6) | |
HGBL (including NOS and DHL/THL) | 43 (9.8) | 50 (11.4) | ||
Other large B cell‖ | 24 (5.5) | 22 (5.0) |
DLBCL, NOS represented ~85% of LBCL cases in POLARIX, similar to real world estimates1,16
*This variable was a stratification factor.
†Patients were to have a baseline ECOG PS score of 0-2 (on a 5-point scale, with higher numbers indicating greater disability). ECOG PS was not reported for 1 patient in the R-CHOP group.
‡Bulky disease was defined as the presence of 1 or more lesions that were 7.5 cm or larger in greatest dimension.
§Stages range from I to IV, with higher stages indicating more extensive disease.
IIOther large B-cell lymphomas by local diagnosis included EBV+ DLBCL, NOS, and T-cell/histiocyte rich large B-cell lymphoma.
ABC = activated B cell; AUS = Australia; BICR = blinded independent central review; CAN = Canada; CNS = central nervous system; DHL = double-hit lymphoma; EBV+ = Epstein-Barr virus-positive; ECOG PS = Eastern Cooperative Oncology Group performance status; EOT = end of treatment; GCB = germinal center B cell; IV = intravenous; LBCL = large B-cell lymphoma; PET-CT = positron emission tomography and computed tomography; THL = triple-hit lymphoma; USA = United States of America; W. Europe = Western Europe.
POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.
POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed February 27, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed February 27, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
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Data on File. South San Francisco, CA; Genentech, Inc. 2023.
Data on File. South San Francisco, CA; Genentech, Inc. 2023.
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