KEY TAKEAWAYS
- The Phase 3 POLARIX study (NCT03274492) revealed that the combination of Pola-R-CHP improved PFS compared R-CHOP in previously untreated DLBCL.
- Consistency of PFS was evaluated in an Asia subpopulation, with 281 patients analyzed from the global ITT population and 121 from an ITT China extension cohort.
- Results showed that PFS met the consistency definition with the global population and was significantly better with Pola-R-CHP than R-CHOP (HR 0.64; 95% CI 0.40-1.03).
- Safety profiles were similar between the two treatment arms, including rates of grade 3-4 adverse events (AEs), serious AEs, grade 5 AEs, AEs leading to discontinuation of study treatment, and any-grade peripheral neuropathy.
- These findings indicate that Pola-R-CHP is efficacious and tolerable in both the Asian and global populations in the POLARIX study.
With comparable safety, the phase 3 POLARIX research (NCT03274492) found that adding polatuzumab vedotin to rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) significantly improved progression-free survival (PFS) in previously untreated diffuse large B-cell lymphoma. Patients were assigned a 1:1 chance of receiving either 6 cycles of Pola-R-CHP or 6 cycles of R-CHOP + 2 cycles of rituximab alone.
Consistency of PFS in an Asia subpopulation (defined as ≥50% of the risk reduction in PFS expected in the global population) was studied for POLARIX registration in China. A total of 281 patients were evaluated, including 160 patients from Asia who were included in the worldwide study’s intent-to-treat (ITT) group and 121 patients from an ITT China extension cohort. They were split into 2 groups: 141 received Pola-R-CHP, and 140 received R-CHOP.
The data cutoff was June 28, 2021, with a median follow-up of 24.2 months. Compared to R-CHOP, PFS was better with Pola-R-CHP (hazard ratio, 0.64; 95% CI, 0.40-1.03). Survival rates at 2 years were 74.2% (95% CI, 65.7-82.7) with Pola-R-CHP and 66.5% (95% CI, 57.3-75.6) with R-CHOP.
The results showed that Pola-R-CHP had comparable safety and efficacy compared to R-CHOP. The percentage of patients with Grade 3-4 adverse events (AEs) was 72.9% for Pola-R-CHP and 66.2% for R-CHOP, respectively. Likewise, the percentage of patients with serious AEs was 32.9% for Pola-R-CHP and 32.4% for R-CHOP. Grade 5 AEs were observed in 1.4% of patients in the Pola-R-CHP group and 0.7% in the R-CHOP group. Additionally, 5.0% of patients in the Pola-R-CHP group and 7.2% in the R-CHOP group experienced AEs leading to the discontinuation of the study treatment. Any-grade peripheral neuropathy was observed in 44.3% of patients in the Pola-R-CHP group and 50.4% in the R-CHOP group.
Overall, these results demonstrate the comparable safety and efficacy of Pola-R-CHP versus R-CHOP in both the Asian and global populations in POLARIX. The findings of this study suggest that Pola-R-CHP may be an effective and safe treatment option for adult patients with previously untreated DLBCL.
Source: https://ashpublications.org/blood/article/doi/10.1182/blood.2022017734/494074/Polatuzumab-vedotin-in-previously-untreated-DLBCL
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03274492
Song Y, Tilly H, Rai S, Zhang H, Jin J, Goto H, Terui Y, Shin HJ, Kim WSS, Cao J, Feng J, Eom HS, Kim TM, Tsai XC, Gau JP, Koh H, Zhang L, Song Y, Yang Y, Li W, Huang H, Ando K, Sharman JP, Sehn LH, Bu L, Wang X, Jiang Y, Hirata J, Lee C, Zhu J, Izutsu K. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the Phase 3 POLARIX trial. Blood. 2023 Jan 10:blood.2022017734. doi: 10.1182/blood.2022017734. Epub ahead of print. PMID: 36626583.
