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iNature
In the Phase 3 POLARIX study (NCT03274492), polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) had a similar safety profile in previously untreated diffuse large B-cell lymphoma in previously untreated diffuse large B-cell lymphoma, with a similar safety profile of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), significantly improving progression-free survival ( progression-free survival，PFS)
。
On January 10, 2023, Yuqin Song's team from Peking University published an online report entitled "Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the Phase 3 POLARIX trial" online in Blood (IF=25) magazine To characterize the efficacy and safety of Pola-R‐CHP to support its regulatory filing in China, an Asian subpopulation analysis
of the POLARIX study was conducted.
This subpopulation includes patients recruited from Asia during the global study phase, as well as a Chinese expansion cohort recruited after the completion of the global study to increase the number of
patients from China in the study.
THIS REPORT REPORTS THE EFFECTIVENESS AND SAFETY RESULTS
OF POLARIX'S ASIAN SUBPOPULATION ANALYSIS.
THE FINDINGS SHOWED THAT POLARIX-R-CHP WAS CONSISTENT
WITH R-CHOP EFFICACY AND SAFETY IN ASIAN AND GLOBAL POPULATIONS.
8%, 36.
0% and 48.
4% of all cases in China, Japan and South Korea, respectively The current standard of care (SoC) for DLBCL as the first line (1L) is anti-CD20 monoclonal antibody rituximab (rituximab, R) combined with CHOP regimen (cyclophosphamide + doxorubicin + vincristine + prednisone, cyclophosphamide, doxorubicin, vincristine, and prednisone) although R‐ CHOP is an effective therapy that produces a clinical response, but 30-40% of patients subsequently relapse or become difficult to treat
.
Until recently, attempts to improve the efficacy of R‐CHOP in the treatment of DLBCL have not provided meaningful results, and R‐CHOP remains SoC
.
Polatuzumab vedotin includes an anti-CD79b monoclonal antibody conjugated by a protease-cleaved linker to a potent microtubule inhibitor, monomethylauristatin E, CD79b, a subunit of the B-cell receptor, widely expressed in mature B-cell lymphomas, including DLBCL.
Antibodies bound to CD79b are rapidly internalized, making CD79b ideal for targeted delivery of cytotoxic drugs
.
Whether used alone or in combination with bendamustine and rituximab, Polatuzumab vedotin has shown good efficacy and controllable toxicity
in the treatment of relapsed/refractory DLBCL 。 Recently, polatuzumab vedotin in combination with rituximab + cyclophosphamide, axorubicin, and prednisone (Pola‐R‐CHP) in a phase 3 POLARIX study (NCT03274492) showed higher progression-free survival (PFS) compared with R‐CHOP (stratified hazard ratio [HR] 0.
73; 95% confidence interval (CI), 0.
57-0.
95); The security of the two scenarios is similar
.
To register POLARIX in China, the study assessed the consistency of PFS in Asian subpopulations (defined as ≥ 50% reduction in PFS risk in the global population).
Patients were randomized 1:1 into 6 cycles of Pola-R-CHP or R-CHOP plus 2 cycles of rituximab
.
A total of 281 patients were analyzed: 160 from Asia and 121 from the ITT China extended cohort
in the global study intention-to-treat (ITT) population.
Of these, 141 were randomized to the Pola-R-CHP group and 140 to the R-CHOP group
.
As of the data cut-off date (June 28, 2021; median follow-up 24.
2 months), PFS met a consistent definition of the global population, and Pola-R-CHP was superior to R-CHOP (hazard ratio 0.
64; 95% confidence interval [CI], 0.
40-1.
03).
The 2-year PFS for Pola-R-CHP and R-CHOP were 74.
2% (95% CI, 65.
7-82.
7) and 66.
5% (95% CI, 57.
3-75.
6),
respectively 。 The safety profile of Pola-R-CHP and R-CHOP was comparable, including grade 3-4 adverse event rates (AEs; Severe AEs (32.
9% vs 32.
4%), with grade 5 AEs (1.
4% vs 0.
7%), AEs leading to study treatment discontinuation (5.
0% vs 7.
2%), and any grade of peripheral neuropathy (44.
3% vs 50.
4%)
.
Kaplan-Meier plots for (A) Investigator – assessed PFS, (B) Investigator – EFS assessed, (C) OS and D) DFS (ITT) (from Blood) In summary, the results of this PFS analysis in Asian populations (HR 0.
64) met the consistency criteria for the primary findings of the POLARIX global study population, and the secondary efficacy analysis supported the primary endpoint finding showing Pola‐ Benefits of
R-CHP in EFS, CR rate at the end of treatment, and DFS.
At the time of analysis, OS data were immature, but there were fewer deaths in the Pola-R‐CHP group than in the R-CHOP group
.
Original link: https://doi.
org/10.
1182/blood.
2022017734
—END—
The content is [iNature]
