POLARIX
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
Phase 3N = 879NCT03274492
- Population
- Previously untreated intermediate-risk or high-risk diffuse large B-cell lymphoma, aged 18 to 80 years.
- Design
- Double-blind, placebo-controlled, international phase 3 trial: six cycles of pola-R-CHP (polatuzumab vedotin replacing vincristine, with a placebo for vincristine) or R-CHOP (with a placebo for polatuzumab vedotin), plus two cycles of rituximab alone, 1:1 randomisation. ClinicalTrials.gov lists an actual enrolment of 1000, which the five-year paper explains as 879 global patients plus a 121-patient Chinese extension cohort.
- Primary endpoint
- PFS
- Arms
- R-CHOP (control, n = 439): Six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone plus placebo, then two cycles of rituximab alone
- Pola-R-CHP (experimental, n = 440): Six cycles of polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin and prednisone, then two cycles of rituximab alone
- People
- Tilly H, senior author Salles G
PFSHR 0.73 (95% CI 0.57–0.95)Δ 24-month PFS+6.5 pointsOSHR 0.94 (95% CI 0.65–1.37)Δ 24-month OS+0.1 pointsPFSHR 0.77 (95% CI 0.62–0.97)Δ 60-month PFS+5.8 points
Show the numbers
| Endpoint | Analysis | Pola-R-CHP | R-CHOP | Effect |
|---|---|---|---|---|
| PFSIntention-to-treat population (all 879 randomised patients, as defined in the full text)Investigator-assessed progression-free survival (stated primary end point). | primarymedian follow-up 28.2 monthsTilly 2022 | 76.7% at 2 y (72.7–80.8%) | 70.2% at 2 y (65.8–74.6%) | HR 0.73 (95% CI 0.57–0.95)P=0.02Two-year rates; stratified hazard ratio for progression, relapse or death by Cox regression. |
| OSIntention-to-treat population (all 879 randomised patients, as defined in the full text) | primarymedian follow-up 28.2 monthsTilly 2022 | 88.7% at 2 y (85.7–91.6%) | 88.6% at 2 y (85.6–91.6%) | HR 0.94 (95% CI 0.65–1.37)P=0.75Secondary end point; difference not statistically significant. |
| PFSGlobal intention-to-treat population (N = 879) | long term-updatemedian follow-up 64.1 monthsMorschhauser 2025 | 64.9% at 5 y (59.8–70.0%) | 59.1% at 5 y (53.9–64.3%) | HR 0.77 (95% CI 0.62–0.97)Five-year update; the abstract calls the PFS difference significant and gives no p-value. |
| OSGlobal intention-to-treat population (N = 879) | long term-updatemedian follow-up 64.1 monthsMorschhauser 2025 | — | — | HR 0.85 (95% CI 0.63–1.15)Not statistically significant per the abstract; the hazard ratio at the 2-year data cut was 0.94 (95% CI 0.67 to 1.33) in this report (0.94, 0.65 to 1.37 in the primary paper). |
| Endpoint | Analysis | Pola-R-CHP | R-CHOP | Effect |
|---|---|---|---|---|
| PFSIntention-to-treat population (all 879 randomised patients, as defined in the full text)Investigator-assessed progression-free survival (stated primary end point). | primarymedian follow-up 28.2 monthsTilly 2022 | 76.7% at 2 y (72.7–80.8%) | 70.2% at 2 y (65.8–74.6%) | HR 0.73 (95% CI 0.57–0.95)P=0.02Two-year rates; stratified hazard ratio for progression, relapse or death by Cox regression. |
| OSIntention-to-treat population (all 879 randomised patients, as defined in the full text) | primarymedian follow-up 28.2 monthsTilly 2022 | 88.7% at 2 y (85.7–91.6%) | 88.6% at 2 y (85.6–91.6%) | HR 0.94 (95% CI 0.65–1.37)P=0.75Secondary end point; difference not statistically significant. |
| PFSGlobal intention-to-treat population (N = 879) | long term-updatemedian follow-up 64.1 monthsMorschhauser 2025 | 64.9% at 5 y (59.8–70.0%) | 59.1% at 5 y (53.9–64.3%) | HR 0.77 (95% CI 0.62–0.97)Five-year update; the abstract calls the PFS difference significant and gives no p-value. |
| OSGlobal intention-to-treat population (N = 879) | long term-updatemedian follow-up 64.1 monthsMorschhauser 2025 | — | — | HR 0.85 (95% CI 0.63–1.15)Not statistically significant per the abstract; the hazard ratio at the 2-year data cut was 0.94 (95% CI 0.67 to 1.33) in this report (0.94, 0.65 to 1.37 in the primary paper). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.73 | 0.57–0.95 |
| OS | 0.94 | 0.65–1.37 |
| PFS | 0.77 | 0.62–0.97 |
| OS | 0.85 | 0.63–1.15 |
Appears in
Sources
Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trněný M, Sharman JP, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;386(4):351-363.
Morschhauser F, Salles G, Sehn LH, Herrera AF, Friedberg JW, Trněný M, et al. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025;43(35):3698-3705.