POLARIX
Trial question
What is the role of polatuzumab vedotin in patients with previously untreated intermediate- or high-risk diffuse large B-cell lymphoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 879
879 patients (406 female, 473 male)
Inclusion criteria: patients, aged 18-80 years, with previously untreated intermediate- or high-risk diffuse large B-cell lymphoma
Key exclusion criteria: history of indolent lymphoma; contraindication to any component of the rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone regimen; previous receipt of anthracycline agents; and known CNS involvement
Interventions
N=440 Pola-R-CHP (polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone)
N=439 R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Primary outcome
Progression-free survival at 2 years
76.7
70.2
76.7 %
57.5 %
38.4 %
19.2 %
0.0 %
Pola-R-CHP
R-CHOP
Significant
increase ▲
NNT = 15
Significant increase in progression-free survival at 2 years (76.7% vs. 70.2%; HR 1.37, 95% CI 1.05 to 1.75)
Secondary outcomes
Significant increase in event-free survival (74.5% vs. 68.6%; HR 1.33, 95% CI 1.04 to 1.72)
No significant difference in overall survival (88% vs. 87%; HR 1.06, 95% CI 0.73 to 1.54)
Borderline significant increase in disease-free survival (83.7% vs. 78.2%; HR 1.43, 95% CI 1.02 to 2)
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients, aged 18-80 years, with previously untreated intermediate- or high-risk diffuse large B-cell lymphoma, Pola-R-CHP was superior to R-CHOP with respect to a progression-free survival at 2 years.
Reference
Hervé Tilly, Franck Morschhauser, Laurie H Sehn et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363.
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