POLARIX Trial

POLARIX: Designed to evaluate PFS superiority of POLIVY® + R-CHP over R-CHOP in a head-to-head trial¹

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 was studied in a range of patients with previously untreated LBCL¹

Patient characteristics were well-balanced across POLARIX treatment arms^1,2

DLBCL, NOS represented ~85% of LBCL cases in POLARIX, similar to real world estimates^1,3

*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.

References:

1. POLIVY, Israeli MoH approved prescribing information,Aug 2022
2. Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;386(4):351​-363.
3. Li S, Young KH, Medeiros LJ. Diffuse large B-cell lymphoma. Pathology. 2018;50(1):74-87. 

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