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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
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The phase III POLARIX study (NCT03274492) investigated polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus standard of care (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) as frontline treatment for patients with diffuse large B-cell lymphoma (DLBCL). Previously, the Lymphoma Hub has reported primary results from POLARIX and the Food and Drug Administration (FDA) approval of polatuzumab vedotin in combination with R-CHP in patients with previously untreated DLBCL. Below, we summarize results from the Asia subpopulation analysis of the POLARIX study investigating the safety and efficacy of polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).1
This was a double-blind, placebo-controlled, international phase III study. Previously untreated patients with DLBCL were included in the analysis from the Asia subpopulation and the China extension cohort. Patients included were
Patients were randomized to Pola-R-CHP (n = 141) and R-CHOP (n = 140). The study protocol, schedule of assessments, and treatment were the same across patients analyzed in this subpopulation and the global cohort; stratification factors included IPI score and bulky disease, defined as absent or present with a lesion >7.5 cm. The primary endpoint was progression-free survival (PFS) and the primary safety endpoint was the incidence of adverse events (AEs).
Overall, 281 patients were included in the study (Asia subpopulation, n = 160; China extension cohort, n = 121). The patient’s baseline demographics and clinical characteristics were balanced across the treatment arms (Table 1).
Table 1. Baseline patient demographics and clinical characteristics (intention-to-treat population)*
Characteristic, % (unless otherwise stated) |
Pola-R-CHP (n = 141) |
R-CHOP (n = 140) |
---|---|---|
Median age range, years |
19–79 |
23–78 |
Age |
|
|
<65 years |
58.9 |
52.1 |
≥65 years |
50.4 |
55.7 |
Country |
|
|
Mainland China |
53.2 |
53.6 |
Japan |
30.5 |
30.0 |
Republic of Korea |
10.6 |
11.4 |
Taiwan |
5.7 |
5.0 |
Ann Arbor stage |
|
|
I–II |
13.5 |
15.0 |
III–IV |
86.5 |
85.0 |
Extranodal sites |
|
|
0–1 |
82.3 |
86.4 |
2 |
17.7 |
13.6 |
Bulky disease† |
|
|
<7.5 cm |
68.8 |
66.4 |
≥7.5 cm |
31.2 |
33.6 |
ECOG Performance status |
|
|
0–1 |
82.3 |
86.4 |
2 |
17.7 |
13.6 |
LDH level |
|
|
Normal |
31.9 |
29.3 |
Elevated |
68.1 |
70.7 |
Median time from initial diagnosis to treatment initiation (IQR), days |
17 (10–29) |
15 (10–26) |
IPI score, %† |
|
|
2 |
38.3 |
37.9 |
3–5 |
61.7 |
62.1 |
Cell of origin‡ |
|
|
GCB |
30 |
40 |
ABC |
55 |
46 |
Unclassified |
15 |
14 |
DEL‡ |
|
|
DEL |
31.8 |
36.3 |
Non-DEL |
68.2 |
63.7 |
Double/triple hit lymphoma‡ |
|
|
Yes |
2.9 |
5.1 |
No |
97.1 |
94.9 |
Previous history of hepatitis B infection§ |
32.1‖ |
42.4 |
ECOG, Eastern Cooperative Oncology Group; IPI score, integrated pulmonary index; Pola-R-CHP, polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. *Data from Song, et al.1 |
Figure 1. Primary and key secondary efficacy outcomes (intention-to-treat population)*
DFS, disease free survival; EFS, even free survival; ORR, objective response rate; OS, overall survival; Pola-R-CHP, polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
*Adapted from Song, et al.1
Figure 2. Treatment-emergent Grade 3/4 AEs (safety-evaluable population)*
AE, adverse event; Pola-R-CHP, polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
*Adapted from Song, et al.1
These findings demonstrate the consistent efficacy and safety of Pola-R-CHP vs R-CHOP in the Asia and global populations of previously untreated patients with DLBCL enrolled in the POLARIX study. Of note, the subpopulation analysis is limited by a considerably smaller cohort and variability in follow-up compared with the entire study population.
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